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A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
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The In4M Study: Integrating 4 Measures to Assess Physical Function in Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the measurement characteristics of these different sources of physical function data in a cancer population undergoing cytotoxic chemotherapy.
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A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to use the shared decision-making (SDM) tool in clinical conversations to test whether these SDM tools affect patient understanding, treatment fidelity, or outcomes in patients with lung cancer.
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A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
Rochester, MN
This study will assess the ability of the Pathos platform to predict which patients will respond to certain colorectal cancer drug treatments. To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with the rate of first line response.
To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with progression free survival.
To demonstrate that for patients with advanced colorectal cancer who meet the endpoint of first line response, prediction scores ...
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Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.
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A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression
Rochester, MN
The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).
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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses.
Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.
Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study ...
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Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
Rochester, MN
The purpose of this study is to assess the toxicity and effectiveness of bevacizumab with APG-157 for recurrent high grade glioma patients with disease progression after bevacizumab.
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A Study to Assess Dynamic Changes in Plasma Proteome to Identify Early Detection and Treatment Response Biomarkers for HGSOC
Rochester, MN
This study aims to identify candidate High Grade Serous Cancer (HGSC) early detection and chemotherapy treatment response biomarkers. For the purpose of this study we define high grade serous cancers to include invasive cancers arising in the ovary and/or fallopian tubes (FT). Using mass spectrometry we will deeply profile and quantitate dynamic changes in the plasma proteome and N-gylcocapture sub-proteome that occur as a consequence of surgical debulking and platinum-based chemotherapy.
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A Study to See if the Depth of Tumor Invasion of Esophageal Carcinoma Predicts Lymph Node Involvement and Cancer Free Survival
Rochester, MN
The purpose of this study is to see if different depths of submucosal tumor invasion in esophageal cancer can predict lymph node involvement and survival.
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A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
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ALPN-202 With PD-1 Inhibition in Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate ALPN-202 with PD-1 inhibition to treat adults with advanced solid tumors or lymphoma.
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A Study to Explore Cancer Patient Experiences and Their Decisions About Sharing Genetic Cancer Screening Information with Family Members
Rochester, MN
The purpose of this study is to characterize the beliefs and attitudes of cancer patients who received a positive result from a genetic cancer screen as part of the Mayo Clinic Intercept study (IRB#18-000326, PI: Samadder). This data will be collected using semi-structured, one-on-one interviews.
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Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
Jacksonville, FL; Rochester, MN
The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.
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Care Processes and Person Centered Care of Patients with Neuroendocrine Tumors
Rochester, MN
Given that neuroendocrine tumors (NETs) represent a rare condition with complex treatment decisions and a lack of concrete guidance for physicians, shared-decision making (SDM) is particularly challenging.In an effort to improve PCC, we hope to identify care processes throughout the clinical encounter that are important to patients. Identifying these processes would allow for standardization of the care environment without focusing on specific provider characteristics. As such, changes to the institutional and system-level processes could be made in more actionable and systematic ways.
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Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer (FRAPPE)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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PRT3789 Monotherapy And In Combo W/Docetaxel In Participants W/Advanced Or Metastatic Solid Tumors W/SMARCA4 Mutation
Jacksonville, FL; Rochester, MN
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
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A Trial To Find Out If REGN5678 Is Safe And How Well It Works Alone Or In Combination With Cemiplimab For Adult Participants With Metastatic Castration-Resistant Prostate Cancer And Other Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at ...
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Neoadjuvant dual checkpoint blockade with PD1 and LAG-3 inhibition in resectable Non-small cell lung Cancer
Rochester, MN; Jacksonville, FL
The purpose of this study is toassess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥50%, as measured by rate of major pathologic response (MPR).
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A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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Sequential Treatments Or Combinations Including Dasatinib, Quercetin, Fisetin And/or Temozolomide For The Treatment Of Previously Treated Glioma With Residual Disease
Rochester, MN
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They ...
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A Study Of BH-30643 In Subjects With Locally Advanced Or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the ...
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A Study to Evaluate Enfortumab Vedotin to Treat Metastatic Squamous Cell Carcinoma of the Penis
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to estimate the best response of enfortumab vedotin treatment for patients with metastatic squamous cell carcinoma of the penis (PSCC).
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A Study to Evaluate Zanubrutinib to Treat Patients with B-cell Malignancies
Rochester, MN
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one ...
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Combination Therapies with Adagrasib in Patients with Advanced NSCLC With KRAS G12C Mutation
Rochester, MN; Jacksonville, FL
The purpoes of this study is to evaluate the clinical effectiveness of combination therapies with adagrasib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with TPS ≥ 1% and KRAS G12C mutation
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Virtual Reality Intervention To Improve Psychological Symptom Burden For Cancer Patients Undergoing Treatment
Jacksonville, FL
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to ...
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Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary effectiveness of JANX007 administered as a single agent in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
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Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with ...
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A Phase Ⅲ Study Of Rilvegostomig In Combination With Fluoropyrimidine And Trastuzumab Deruxtecan As The First-line Treatment For HER2-positive Gastric Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD-L1 CPS ≥ 1. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
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Impact Of Restricted Medication Access On Care Of Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to evaluate differences in time to fill lenalidomide, pomalidomide and thalidomide (iMiDs) prescribed by a health-system provider (HSP) when the health-system specialty pharmacy is either 1) in both the limited distribution (LDD) network and payor network, 2) in the LDD network but payor lock out, or 3) not in the LDD network. To accomplish this aim, we will perform a mixed methods study using quantitative data to evaluate time to medication access and qualitative data using surveys to assess patient and provider experiences.
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Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF).
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Study of LY2784544 Testing Alternative Dosing in Participants with Myeloproliferative Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms.
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A Study of X4P-001 in Patients with Advanced Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the study is to test different doses of X4P-001 given alone and in combination with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.
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A Comprehensive Evaluation Of Immunity In Lymphoma Patients
Rochester, MN
The purpose of this study is to address the current knowledge gaps by providing comprehensive and dynamic characterization of the different components of the immune system in patients diagnosed with lymphoma.
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A Study to Evaluate Intravenous Ascorbic Acid (Vitamin C) as an Adjunct to Pazopanib in the First-Line or Post-immunotherapy Setting for Metastatic or Unresectable Clear Cell Renal Cell Carcinoma (ccRCC)
Rochester, MN
This randomized phase II trial studies how well pazopanib hydrochloride with or without ascorbic acid work in treating patients with kidney cancer that has spread to other places in the body or cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ascorbic acid may help pazopanib hydrochloride stop tumor growth and improve treatment survival. Giving pazopanib hydrochloride and ascorbic acid may work better in treating patients with kidney cancer.
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The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
No Locations
The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared to LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.
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Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Rochester, MN
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
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A Drug-drug Interaction Study of Avapritinib and Midazolam to Treat Unresectable or Metastatic Gastrointestinal Stromal Tumors and Other Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to investigate the effect of Avapritinib on the pharmacokinetics of Midazolam in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) or other advanced solid tumors.
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Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Rochester, MN
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
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Project Survival-Prospective Biomarker Discovery
Scottsdale/Phoenix, AZ
This sample-collection study is open to participants in several categories: healthy volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed with pancreatitis or any stage of pancreatic cancer. All participants will submit urine, saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue samples if biopsy/ies or surgery is part of the care being provided by their doctor. In partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early detection of pancreatic cancer, to determine prognosis of patients, and to find the most appropriate treatments for patients.
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Study of BMF-219, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), and Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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A Study to Analyze Symptoms and Quality of Life Issues in Women Living with Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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A Study of STRO-001 in Patients with Advanced B-Cell Malignancies
Jacksonville, FL
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and preliminary effectiveness of STRO-001 given intravenously every 2 weeks to patients with advanced b-cell malignancies.
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Lurbinectedin + Doxorubicin In Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma, and to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
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An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy.
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A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor activity.
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Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).
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A Study to Review the Safety of Familial Adenomatous Polyposis/Erlotinib Study
Scottsdale/Phoenix, AZ
The purpose of this study is to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, who provide consent for the review of their medical records. There have been reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. A review of literature found insufficient data to determine whether or not there is a longer term safety risk to the participant in MAY2016-07-01.
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Study of DCC-3014 in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of DCC-3014 in patients with solid tumors including, but not limited to, prostate, breast, gastric, ovarian, and non-small cell lung cancer, as well as tumor types with high macrophage content or high expression of CSF-1 such as tenosynovial giant cell tumor. There will be an Escalation Phase and an Expansion Phase in this study.
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A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.
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Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Scottsdale/Phoenix, AZ
The purpose of the study is to provide access to continued treatment for subjects who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and for whom the Investigator feels may have potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.
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A Study to Evaluate AZD1775 in Women with Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for uterine cancer, AZD1775.
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Outcomes Database To ProspectivelY ASSEss The Changing TherapY Landscape In Renal Cell Carcinoma (ODYSSEY RCC)
Rochester, MN
The purpose of this study is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.
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A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.
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Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Rochester, MN
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial will determine whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources.
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Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced).
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A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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Phase 3 Study Of T-DXd And Rilvegostomig Versus SoC In Advanced HER2-expressing Biliary Tract Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
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A Study of SC-007 in Subjects With Advanced Cancer
Rochester, MN
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
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First-in-Human Study of FLX925 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This first-in-human clinical trial is a Phase 1/1b, open-label, sequential-group, dose-escalation and cohort expansion study evaluating the safety, and antitumor activity of FLX925 in people with relapsed or refractory Acute Myeloid Leukemia.
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Digital Biomarker And Omics-Based Assessment Of Surgical Resiliency In Children Undergoing Solid Tumor Resection
Rochester, MN
The purpose of this study is to demonstrate 1) feasibility of digital biomarker assessment using wearable in children with solid tumors who undergo surgery and 2) alterations in circulating proteins and metabolites indicative of a stressed state will persist postoperatively and correlate with clinical signs of recovery.
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Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL in hematologic morphologic complete remission or complete remission with incomplete hematologic recovery. The secondary objectives include; evaluation of morphologic relapse free survival (RFS), evaluation of overall survival (OS), assessment of the the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase, assessment of adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL, and assessment of flow cytometry based MRD status on Day 64 of ...
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A Phase 3, randomized, open-label, controlled study comparing the efficacy and safety of zanidatamab to trastuzumab, each in combination with physician’s choice chemotherapy, for the treatment of participants with metastatic HER2-positive breast cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.
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Efficacy And Safety Of Nemtabrutinib (MK-1026) In Participants With Hematologic Malignancies (MK-1026-003)
Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
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Study To Evaluate The Efficacy And Safety Of Ersodetug In Patients With Inadequately Controlled Hypoglycemia Due To Tumor-Associated Hyperinsulinism
Rochester, MN
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in participants with inadequately controlled hypoglycemia due to islet-cell (insulinomas) and non-islet cell tumor hyperinsulinism.
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Study Of Lurbinectedin In Combination With Doxorubicin Versus Doxorubicin Alone As First-line Treatment In Participants With Metastatic Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
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A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Rochester, MN
The purpose of this study is to assess whether minimal residual disease (MRD) driven finite calabrutinib plus venetoclax (AV) treatment is non-inferior to MRD-driven finiteenetoclax plus obinutuzumab (VO) treatment with respect to progression-free survival (PFS).
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A Study To Evaluate Personalized Molecular Marker And Immunoprofiling To Transform Hepatocellular Carcinoma Treatment
Jacksonville, FL
The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.
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Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy Or Plus Camizestrant In HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, Or PALB2m Advanced Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.
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Study Of Datopotamab Deruxtecan Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
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Study of VS-6766 + Adagrasib in KRAS G12C NSCLC Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
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Novel Total Body Photography System for Accessible and Accurate Skin Cancer Screening
Rochester, MN
The overall goal of this pilot study is to assess initial quality and feasibility of a novel protoype TBP system that may be used in the future for accurate and accessible skin cancer screening called Skinmap. Skinmap’s automatic anatomical registration will be sufficient to permit accurate alignment of baseline overlays on current imagery for visual and automated detection of changes 1mm or greater on 95% of exposed skin in baseline and current image sets. The teams of Triangulate Labs and Mayo Clinic Enterprise Dermatology propose to validate, refine, and explore the clinical utility of Skinmap.
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A Study of Selpercatinib Following Definitive Locoregional Treatment in Participants with Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to compare Event-Free Survival (EFS) of participants in the primary analysis population with Stage II-IIIA RET fusion-positive Non-small Cell Lung Cancer (NSCLC) treated with selpercatinib versus placebo.
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Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are unfit for radical cystectomy (RC) during an 84-day induction period comprised of four consecutive 21-day dosing cycles.
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Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade, Non-muscle Invasive Bladder Cancer
Jacksonville, FL; Rochester, MN
The primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.
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Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
Scottsdale/Phoenix, AZ; Rochester, MN
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.
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International Precision Medicine Consortium for Neurooncology Research
Rochester, MN
The purpose of this study is to collect minimal risk normal samples, both prospectively collected and those stored at the patient's home institution and any outside institutions, along with clinical data. For this same end, the study provides for a wide scope of research, including detailed genetic analysis, and provides mechanisms for reporting of results back to participants and/or their treating physicians.
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A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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An Investigational Scan (Ga-68 PSMA-11 PET/CT) For Detection Of Disease Recurrence Or Progression In Patients With Glioma
Rochester, MN
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a ...
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Calaspargase Pegol On The Coagulation System In Pediatric Acute Lymphoblastic Leukemia (ALL) Patients
Rochester, MN
The purpose of this study is to evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in Pediatric Acute Lymphoblastic Leukemia (ALL) patients.
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In-home Intravesical Chemotherapy For The Treatment Of Bladder Cancer, INVITE Trial
Jacksonville, FL
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. ...
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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,
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Hereditary Cancer Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a clinical registry database of all patients seen at Mayo Clinic Florida who have completed genetic testing through Mayo Clinic Florida or are seen due to a previously identified hereditary cancer risk.
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A Study Of Abenacianine (VGT-309) To Identify Cancer When Undergoing Surgery For Cancer In The Lung
Rochester, MN
The purpose of this study is assess the efficacy of abenacianine with near-infrared (NIR) imaging as an adjunct for lesion visualization and surgical guidance when compared to standard surgical techniques in subjects undergoing surgery for suspected or proven cancer in the lung.
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Dynamics Of Clinical Trial Discussions In Oncology To Identify Patient Barriers And Help Develop A Patient-centered Intervention To Increase Participation In Clinical Trials
Rochester, MN
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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INCB161734 For Advanced Or Metastatic Solid Tumors With KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
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Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia
Scottsdale/Phoenix, AZ
The primary hypothesis of the study is that treatment with either once-daily or twice-daily pacritinib results in a greater proportion of patients with thrombocytopenia and myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥ 50% reduction in total symptom score from baseline to Week 24 as measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0.
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A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open label study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
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NLA101 in Adults Receiving High Dose Chemotherapy for AML
Jacksonville, FL; Rochester, MN
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.
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PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination with Anti-PD-1/L1 in Patients with Locally Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of a pharmacologically active dose (PAD) range of PTT-936, which may include identification of the MTD, administered as a single agent in patients with advanced unresectable or metastatic solid tumors who have progressed after exhaustion of standard of care (SOC) or a SOC is not available.
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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Participants With Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
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A Study to Examine Financial Distress in Patients Undergoing Treatment of Locally-advanced Rectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.
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A Study to Evaluate Belinostat and Guadecitabine or ASTX727 to Treat Unresectable and Metastatic Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess how well belinostat and SGI-110 (guadecitabine) or ASTX727 work in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat and guadecitabine may lower the chance of chondrosarcoma growing or ...
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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INCB161734 For Advanced Or Metastatic Solid Tumors With KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
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The Effects of Acute and Chronic Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase ...
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Immune Archetecture of Stage 4 Triple-Negative Breast Cancer
Jacksonville, FL
The purpose of this study is to identify who may or may not be a good fit for specific cancer treatments. Investigators will be attempting to identify markers that may make someone resistant to specific therapies in order to avoid harsh treatments that would not be effective or target more effective treatments at the offset.
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A Study to Evaluate AVID200 in Myelofibrosis Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of AVID200. Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-β1 and TGF-β3. The study team hypothesizes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. ...
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Collection of Primary Retroperitoneal Sarcoma Data, Radiological, and Pathological Material for the Transatlantic Australasian Retroperitoneal Sarcoma Working Group
Jacksonville, FL
The purpose of this study is to prospectively collect standardized clinical data and radiological and pathological material from primary retroperitoneal sarcomas RPS patients treated with surgery at reference centers. Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
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A Study Evaluating AMG 424 in Subjects With Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Prior clinical experience with CD38-targeting antibodies, including daratumumab, establish this molecule as an important therapeutic target in multiple myeloma. CD38 is a type II transmembrane glycoprotein with both ectoenzymatic and signal transductionfunctions. CD38 dimerization is required for its catalytic activity (Desphande et al, 2017).Dimeric CD38 possesses both ADP ribosyl cyclase and cADPR hydrolyase activities; the former generates cyclic ADP ribose (cADPR) from NAD+ and the latter generates ADPR. CD38-mediated cADPR generation enables calcium release from intracellular stores, leading to a variety of cell type-specific physiological outcomes (Schuber and und, 2004; Lee and Aarhus, 1991). A distinct mode of CD38-dependent signal ...
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A Study of Leukemia Inhibitory Factor Biomarker Monitoring Progression and Treatment Response of Locally-advanced Unresectable and Metastatic Pancreatic Cancer Therapies
Jacksonville, FL
The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.
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A Study of Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with MCL-1 Dependence ≥ 40%
Jacksonville, FL; Rochester, MN
The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.
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A Study of ABBV-085, an Antibody Drug Conjugate, for Patients with Advanced Solid Cancer Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and drug/body interactions of ABBV-085, and to determine the recommended future study dose (alone or in combination with standard therapies) for people who have advanced solid tumors.
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Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma
Rochester, MN
This Phase II studyis designed to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma (PTCL). The total number of patients could be extended to 30 pending on the degree of response observed at an interim analysis. Tipifarnib will be administered until disease progression then followed approximately every 12 weeks for survival until either death or 12 months after accrual of the last study subject, whichever occurs first.
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Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas
Rochester, MN
The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans. This study is also designed to measure how much Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143 (AT-406) interacts with proteins related to cancer that the drug is targeted to affect (pharmacodynamics).
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Developing Criteria for Treatment of Neurofibromatosis Type 1 Associated Optic Pathway Glioma
Rochester, MN
The purpose of this research study is to understand the natural history of vision in patients with OPG and determine if there are factors (e.g. age at diagnosis, male/female, tumor location, features of the MRI exam, etc) that predict future vision loss or change in tumor size.
Another purpose of the study is to collect and store blood and tissue samples to use for future research to evaluate if there are certain variations in DNA, RNA, or proteins that predict the likelihood of an OPG to grow or cause vision loss.
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A Study to Evaluate HH2853 in Patients with Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (how a drug moves within the body) and clinical activity of HH2853, an EZH1/2 Inhibitor, in patients with relapsed/refractory Non-Hodgkin's lymphomas or advanced solid tumors.
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A Study to Examine Financial Distress in Patients Undergoing Treatment of Locally-advanced Rectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.
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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Rochester, MN
The purpose of this study is to compare the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma.
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Phase II Single-arm Study of Tepotinib Combined with Cetuximab
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the preliminary anti-tumor activity, safety, and tolerability, and to explore the pharmacokinetics (PK) of tepotinib in combination with cetuximab in participants with RAS/BRAF oncogene wild-type left-sided metastatic colorectal cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition factor (MET) amplification.
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Study Of GI-102 And PD-1 In Glioblastoma
Rochester, MN
The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.
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Investigations of Reproductive Cancers in Women (PROACTION:)
Rochester, MN
The purpose of this study is to validate a non-invasive diagnostic test with both high-sensitivity and negative predictive value (NPV) for its ability to rule out endometrial cancer.
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Iobenguane I-131 Or Crizotinib And Standard Therapy In Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma Or Ganglioneuroblastoma
Rochester, MN
Despite recent improvements in outcome for children with newly diagnosed high-risk neuroblastoma, cure rates remain unsatisfactory.Further, these gains have been the result of interventions during the Consolidation (tandem autologous stem cell transplant) and Post-Consolidation (dinutuximab immunotherapy) phases of treatment, while rates of disease control during Induction have not improved in recent COG trials. The current phase 3 trial seeks to improve the event-free survival (EFS) for children with high-risk neuroblastoma through early integration of promising novel targeted therapies: targeted radiopharmaceutical therapy with 131I-MIBG or the ALK inhibitor, crizotinib. After enrollment, patients will receive one cycle of Induction chemotherapy. Subsequent therapy ...
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Specimen Collection from Participants Due for Colorectal Cancer Screening, Surveillance, or Treatment
Rochester, MN
The purpose of this study is to collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.
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A Study of RLY-4008 in Patients with Intrahepatic Cholangiocarcinoma and Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), safety profile, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of RLY-4008 in patients with ICC and other advanced solid tumors.
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Patient and Caregiver Perspective About Financial Distress of Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to understand the need and gap in interventions addressing financial burden from a patient perspective, and develop a psychoeducational intervention directed towards decreasing financial distress in patients undergoing cancer treatment based on the knowledge gained.
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A Study to Assess a New Personalized Tool for Colorectal Cancer Peritoneal Disease Treatment
Rochester, MN
The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.
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5-strain Probiotic Formulation in Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Jacksonville, FL
The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF-038 in early-stage breast cancer patients receiving aromatase inhibitors after 3- and 12-month treatment.
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A Study to Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of ...
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A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Rochester, MN
The purpose of this study is to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, Also, to assess the Duration of Response (DOR) 6 months from initial response.
Additionally, to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
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A Study of NB003 in Patients With Advanced Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of NB003 in subjects with Advanced Solid Tumors.
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Solitary Bone Plasmacytomas to Elucidate Their Pathogenesis and Risk of Progression to Multiple Myeloma
Rochester, MN
The purpose of this study is to obtain archived residual formalin-fixed-paraffin-embedded tissue from diagnostic biopsies of solitary bone plasmacytomas for cytogenetic and proteomic testing followed by correlations to their radiographic and clinical features. Clinical, radiographic, and laboratory features of solitary bone plasmacytomas will be evaluated to determine if they can define patients at risk of rapidly progressing to multiple myeloma.
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Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Rochester, MN
The purpose of this study is to evaluating the clinical outcomes of grid therapy.
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Quality of life in older adults with lymphomas
Scottsdale/Phoenix, AZ
The purpose of this study is to identify factors important to decision-making for older adults with indolent lymphomas and to identify minimum clinically significant differences in QOL domains are important to older patients in their decision-making about clinical management. And to characterize longitudinal health-related quality of life (QOL) for older adults with indolent lymphomas.
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A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.
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A Study to Evaluate TAB006, as Monotherapy and in Combination with Toripalimab, in Patients with Previously Treated, Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of multiple doses of TAB006 as monotherapy and in combination with toripalimab to treat advanced malignancies.
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A Study to Evaluate DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study
Rochester, MN
The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.
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Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this trial is to identify the RP2D of STI-6129 by assessing the safety, preliminary effectiveness and pharmacokinetics in treating subjects with relapsed/refractory multiple myeloma (RRMM).
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A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke (EAISE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the effectiveness, safety, tolerability, and pharmacokinetics (PK) of elezanumab in subjects with acute ischemic stroke to potentially accelerate recovery and/or provide more complete recovery by decreasing neuronal damage and enhancing restoration of neuronal activity.
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Blood And Urine Identification Of Methylated DNA Markers In Invasive Bladder Carcinoma
Rochester, MN
The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. Diagnostic accuracy on urine can be compared with that on plasma using paired samples.
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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (ASCLEPIuS)
Rochester, MN
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (phase 2 portion of the study).
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Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Jacksonville, FL
The purpose of this study is to compare three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
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Circulating Tumor DNA (cTDNA) Based in NGS (Next Generation Sequencing) Assays for Oncology Patients With Solid Tumors
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of NGS assays using circulating tumor DNA for the detection of mutations associated solid tumors.
The performance characteristics of these assays for detecting ctDNA mutation in oncology patients will be assessed by comparing the mutation results obtained from these assays to those obtained by orthogonal methods, including tissue-based assays and results from a ctDNA assay by Guardant on blood.
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A Study Of PARG Inhibitor ETX-19477 In Patients With Advanced Solid Malignancies (ERADIC8)
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.
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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. Mayo Clinic will be pariticipating in Part B5, Sparse PK : ART0380 in combination with Irinotecan.
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Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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JAB-23E73 In Adult Participants With Advanced Solid Tumors With KRAS Alteration
Rochester, MN
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
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Screening and Staging of Benign vs Malignant Pelvic Abnormalities
Rochester, MN
The purpose of this study is to integrate GEHC’s AIR Recon DL (ARDL) technique to current protocols while reducing overall scan time.
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A Study To Assess BMS-986458 Alone And In Combination With Anti-lymphoma Agents In Relapsed/Refractory Non-Hodgkin Lymphomas
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader (LDD) of BCL6 (BCL6 LDD), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
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A Study of PF-08052666/SGN-MesoC2 in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that ...
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A Study To Assess Efficacy And Safety Of Pembrolizumab With Or Without Sacituzumab Tirumotecan (MK- 2870) In Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Jacksonville, FL; Rochester, MN
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
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Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety ...
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Escalating Dose Study in Subjects with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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Expanded Access Ga68 PSMA PET Imaging
Rochester, MN
The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.
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A Qualitative Study of Mayo Clinic Calabresi Scholars and Former Scholars
Rochester, MN
To learn from scholars and former scholars of the Mayo Clinic Cancer Center’s “Paul Calabresi Clinical Oncology (K12) Training Program” in their own words what helped them and what did not help them from a career development standpoint.
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A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
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Study of E7386 in Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination with Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
Rochester, MN
Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg bid and trametinib 2 mg once daily in combination therapy and continue on treatment until disease progression, death, or unacceptable adverse event.
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A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Rochester, MN
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: -can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
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A Study Using the New TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients with Metastatic, Persistent, Recurrent, or Progressive Solid Tumors
Scottsdale/Phoenix, AZ
This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in treating patients with a solid tumor that has spread from the primary site (place where it started) to other places in the body (metastatic), progressed for a long time (persistent), come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from ...
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A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
Scottsdale/Phoenix, AZ
A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.
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Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Jacksonville, FL; Rochester, MN
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and INCB039110, a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with INCB039110 in subjects with relapsed/refractory B-cell malignancies.
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Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
Scottsdale/Phoenix, AZ
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
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A Study of PROQOL (Patient Reported Outcome Quality of Life) Tool in the Hematology and Oncology Population
Rochester, MN
The purpose of this study is to assess if the electronic patient reported outcome quality of life (PROQOL) tool will be beneficial to hematology and oncology patients, helping to improve their quality of life by communicating symptoms and needs to busy clinicians.
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Establishing a Possible Correlation Between Chest Wall and Breast Lymphedema
Rochester, MN
The purpose of this study is to address current gaps in research by further establishing a possible correlation between chest wall and breast lymphedema, as measured by the Delfin Moisture Meter D Compact, to a decreased quality of life (LymQOL-midline questionnaire) as well as decreased shoulder function (DASH questionnaire).
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Phase III Study Of Datopotamab Deruxtecan Versus Docetaxel In Previously Treated TROP2-positive Advanced Non-squamous NSCLC Without AGA
Eau Claire, WI; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated TROP2 QCS-NMR positive advanced or metastatic non-squamous NSCLC without AGA, and to assess the clinical performance of the investigational IVD device.
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Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Study will not ...
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Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.
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Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objective of this study is to assess the safety and tolerability, including the maximum tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of ASP2215.
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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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A Study to Evaluate AMG 701 in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine (during the escalation portion) if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects with relapsed / refractory multiple myeloma.
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A Study of Rociletinib (CO-1686) for Patients with a Mutant form of Non-Small Cell Lung Cancer.
Scottsdale/Phoenix, AZ
To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
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A Study of AO-176 as Monotherapy Combinated with Bortezomib and Dexamethasone in Adults with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AO-176, including dose-limiting toxicities (DLT), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) when administered as monotherapy, and in combination with dexamethasone (AO-176+DEX) in adult patients with Relapsed/Refractory Multiple Myleoma (R/R MM).
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
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VSV-hIFNbeta-NIS in Treating Patients With Stage IV or Recurrent Endometrial Cancer
Rochester, MN
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells.
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A Trial of ZL-1201 in Subjects with Advanced Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
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Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Scottsdale/Phoenix, AZ
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD
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An Open-label, Phase 2 Basket Study of Neratinib in Patients with Solid Tumors with Somatic Activating HER Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the effectiveness and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.
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Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Rochester, MN
The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.
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A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of MT-0169 and establish the MTD (maximum tolerated dose)/ RP2D (recommended phase 2 dose). Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease. The study will also examine how the body handles MT-0169. This will be done by looking at the pharmacokinetics of MT-0169after a single dose and after repeat doses in people ...
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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Real-time Disease Monitoring of Metastatic Breast Cancer to Optimize Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to identify subtype-specific signatures for breast cancer using genomic positioning of plasma DNA fragments, and to validate changes in ctDNA levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.
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A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of TAB001 in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2) evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4) evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of TAB001, 2) evaluate the utility of PD-L1 & ...
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Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA
Rochester, MN
Will rigosertib, with an aggressive infusion dose, improve overall survival of MDS better than the treatments available today?
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Selinexor in Advanced Liposarcoma
Jacksonville, FL; Rochester, MN
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 total patients will be randomized to study treatment (selinexor or placebo).
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Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or sporadic meningiomas that have NF2 mutations.
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A Study of the Safety and Tolerability of MEDI1873 for Treating Adult Subjects with Select Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of MEDI1873 for the treatment of adult subjects who have selected advanced solid tumors.
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A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
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I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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A Study to Assess the Safety, Tolerability, and Effectiveness of KPT-9274 to Treat Patients who have Advanced Solid Malignancies or Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.
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XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).
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A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus
Scottsdale/Phoenix, AZ
The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone, and to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing.
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A Study to Evaluate Web-Based Physical Activity Intervention in Children and Adolescents with Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission
Rochester, MN
The primary purpose of this study is to compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.
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A Study of the Safety, Effectiveness and Maximum Tolerated Dose of Oral PQR309 for Patients with Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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Melanoma In-transit Tissue Bank and Molecular Analysis for Personalized Therapies
Rochester, MN; Jacksonville, FL
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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American Society of Hematology Research Collaborative’s Data Hub Multiple Myeloma Program
Rochester, MN
The purpose of this long-term data collection of patients with benign or malignant hematologic diseases is to collect patient demographics, disease characteristics, genomic and molecular data, laboratory data, pathology, radiographic reports, clinical status, quality of life, mediations, and dosing information.
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Retrospective Chart Review of Real-World Treatment Outcomes of Locally Advanced Unresectable Or Metastatic Urothelial Cancer Based on HER2 Expression
Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the real-world Objective Response Rate (rwORR) to standard therapy in subjects with locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC) by human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry (IHC) and in situ hybridization (ISH) scoring.
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HTN Management and Cardiovascular Adverse Event Prevention in B-Cell Malignancies Undergoing BTKi
Rochester, MN
The purpose of this study is to prospectively define the incidence of new and/or worsening hypertension in patients with B-cell malignancies on Bruton Tyrosine Kinase Inhibitors.
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Recruitment/Treatment of Minority Patients on Cancer Trials at Mayo Clinic
Rochester, MN
The short-term goal of this study is to inform the process and mechanisms to enrich URM patient accrual to interventional cancer treatment trials. The long-term goal is to build a patient-centered cancer practice and clinical trial patient population that is reflective of the diverse communities served by Mayo Clinic.
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Study to Test the Safety and Tolerability of PF-07257876 in Participants with Selected Advanced Tumors
Jacksonville, FL; Rochester, MN
The purpose of this FIH study is to assess the safety and tolerability, effectiveness, pharnacokinetcs (PK), and pharmacodynamics (PD) of increasing dose levels of PF-07257876; to identify the MTD and potential RP2D of PF-07257876; and to select the RP2D for further studies in development. This study will enroll patients with advanced cancers with no curative therapy (NSCLC, SCCHN, and OvCa) whose tumors have either failed prior PD-1 or PD-L1 therapies (NSCLC or SCCHN); or platinum-based chemotherapy (OvCa). In addition, patients’ tumors must have demonstrated PD-L1 expression > 1%.
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Dietary and Topical Magnesium Replacement or Supplementation in Patients with Lymphoma
Rochester, MN
The purpose of this research study is to find out if being on a magnesium rich diet and using a magnesium lotion on the skin will help to keep the magnesium blood level in a normal range or increase the magnesium level if it is slightly below the normal range or in the low end of the normal range. We also want to learn about the side effects and quality of life when patients are receiving different forms of magnesium.
Ancient Minerals Magnesium Lotion is an over-the-counter lotion that can be bought at a drug store or ...
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Dose Escalation Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies
Scottsdale/Phoenix, AZ
This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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A Study to Determine Immune System Response in Newly Diagnosed Lymphoma Patients Starting First Line Therapy
Rochester, MN
The study aims to determine whether the baseline immune profile detected in the peripheral blood of patients with lymphoma differs from that of age- and sex-matched controls.
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Understanding Financial Toxicity in Management of Advanced Prostate Cancer from Qualitative Approach
Rochester, MN
The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.
This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.
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A Study to Evaluate Non-Operative Management and Early Response Assessment in Rectal Cancer
Rochester, MN
The purpose of this study is to determine if the complete clinical response rate of patients with Stage I-IIIB (cT1-3, N0-1, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy is greater than 50%.
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Long-term Safety and Effectiveness Study for Participants with Advanced Tumors who are Currently on Treatment or in Follow-up in a Pembrolizumab Trial
Rochester, MN
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.
Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.
Participants who were in the First Course Phase of study treatment in their parent study will enter ...
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DAREON™-9: A Study To Test How Well Different Doses Of BI 764532 Are Tolerated By People With Small Cell Lung Cancer When Taken Together With A Single Agent Chemotherapy
Jacksonville, FL
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study ...
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Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).
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A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study to evaluate the safety and tolerability of GI-102 to define the MTD and/or RP2D.
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MMRC Horizon One Adaptive Platform Trial Evaluating Therapies In RRMM
Rochester, MN
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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Testing Teclistamab (TECVAYLI) In Combination With Iberdomide For Hard-to-Treat Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, ...
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Study Of Tirabrutinib Vs Rituximab/Temozolomide For Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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Expanded Access Ga68 PSMA PET Imaging
Rochester, MN
The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.
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A Qualitative Study of Mayo Clinic Calabresi Scholars and Former Scholars
Rochester, MN
To learn from scholars and former scholars of the Mayo Clinic Cancer Center’s “Paul Calabresi Clinical Oncology (K12) Training Program” in their own words what helped them and what did not help them from a career development standpoint.
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A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
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Study of E7386 in Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination with Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
Rochester, MN
Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg bid and trametinib 2 mg once daily in combination therapy and continue on treatment until disease progression, death, or unacceptable adverse event.
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A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Rochester, MN
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: -can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
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A Study Using the New TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients with Metastatic, Persistent, Recurrent, or Progressive Solid Tumors
Scottsdale/Phoenix, AZ
This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in treating patients with a solid tumor that has spread from the primary site (place where it started) to other places in the body (metastatic), progressed for a long time (persistent), come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from ...
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A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
Scottsdale/Phoenix, AZ
A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.
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Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Jacksonville, FL; Rochester, MN
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and INCB039110, a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with INCB039110 in subjects with relapsed/refractory B-cell malignancies.
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Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
Scottsdale/Phoenix, AZ
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
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A Study of PROQOL (Patient Reported Outcome Quality of Life) Tool in the Hematology and Oncology Population
Rochester, MN
The purpose of this study is to assess if the electronic patient reported outcome quality of life (PROQOL) tool will be beneficial to hematology and oncology patients, helping to improve their quality of life by communicating symptoms and needs to busy clinicians.
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Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA
Rochester, MN
Will rigosertib, with an aggressive infusion dose, improve overall survival of MDS better than the treatments available today?
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Selinexor in Advanced Liposarcoma
Jacksonville, FL; Rochester, MN
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 total patients will be randomized to study treatment (selinexor or placebo).
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Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or sporadic meningiomas that have NF2 mutations.
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A Study of the Safety and Tolerability of MEDI1873 for Treating Adult Subjects with Select Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of MEDI1873 for the treatment of adult subjects who have selected advanced solid tumors.
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A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
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Establishing a Possible Correlation Between Chest Wall and Breast Lymphedema
Rochester, MN
The purpose of this study is to address current gaps in research by further establishing a possible correlation between chest wall and breast lymphedema, as measured by the Delfin Moisture Meter D Compact, to a decreased quality of life (LymQOL-midline questionnaire) as well as decreased shoulder function (DASH questionnaire).
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Phase III Study Of Datopotamab Deruxtecan Versus Docetaxel In Previously Treated TROP2-positive Advanced Non-squamous NSCLC Without AGA
Eau Claire, WI; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated TROP2 QCS-NMR positive advanced or metastatic non-squamous NSCLC without AGA, and to assess the clinical performance of the investigational IVD device.
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A Study of AO-176 as Monotherapy Combinated with Bortezomib and Dexamethasone in Adults with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AO-176, including dose-limiting toxicities (DLT), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) when administered as monotherapy, and in combination with dexamethasone (AO-176+DEX) in adult patients with Relapsed/Refractory Multiple Myleoma (R/R MM).
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
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VSV-hIFNbeta-NIS in Treating Patients With Stage IV or Recurrent Endometrial Cancer
Rochester, MN
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells.
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A Trial of ZL-1201 in Subjects with Advanced Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
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Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Scottsdale/Phoenix, AZ
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD
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An Open-label, Phase 2 Basket Study of Neratinib in Patients with Solid Tumors with Somatic Activating HER Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the effectiveness and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.
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Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Rochester, MN
The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.
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Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Study will not ...
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Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.
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Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objective of this study is to assess the safety and tolerability, including the maximum tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of ASP2215.
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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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A Study to Evaluate AMG 701 in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine (during the escalation portion) if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects with relapsed / refractory multiple myeloma.
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A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of MT-0169 and establish the MTD (maximum tolerated dose)/ RP2D (recommended phase 2 dose). Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease. The study will also examine how the body handles MT-0169. This will be done by looking at the pharmacokinetics of MT-0169after a single dose and after repeat doses in people ...
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of MT-0169 and establish the MTD (maximum tolerated dose)/ RP2D (recommended phase 2 dose). Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease. The study will also examine how the body handles MT-0169. This will be done by looking at the pharmacokinetics of MT-0169after a single dose and after repeat doses in people ...
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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Real-time Disease Monitoring of Metastatic Breast Cancer to Optimize Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to identify subtype-specific signatures for breast cancer using genomic positioning of plasma DNA fragments, and to validate changes in ctDNA levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.
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A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of TAB001 in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2) evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4) evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of TAB001, 2) evaluate the utility of PD-L1 & ...
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XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).
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A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus
Scottsdale/Phoenix, AZ
The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone, and to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing.
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A Study to Evaluate Web-Based Physical Activity Intervention in Children and Adolescents with Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission
Rochester, MN
The primary purpose of this study is to compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.
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A Study to Assess the Safety, Tolerability, and Effectiveness of KPT-9274 to Treat Patients who have Advanced Solid Malignancies or Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.
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A Study of the Safety, Effectiveness and Maximum Tolerated Dose of Oral PQR309 for Patients with Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first in human study in patients with deleted Methylthioadenosine phosphorylase (MTAP) advanced or metastatic solid tumors is to detertamine dose escalation in part one and dose expansion in specific MTAP-deleted tumor types.
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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tisotumab vedotin is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur.
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Surgical Drain Fluid for Detection of Molecular Residual Disease in Patients With Non-small Cell Lung Cancers
Rochester, MN
The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.
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A Study to Investigate LYL845 in Adults With Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
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Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to characterize the safety and tolerability of MRTX1133 as monotherapy or combined with cetuximab in patients with advanced KRAS G12D-mutant solid tumors, and to evaluate the pharmacokinetics (PK) of MRTX1133.
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A Phase 3 Study To Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy In Previously Treated Head And Neck Squamous Cell Carcinoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
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Dual BET And CBP/p300 Inhibitor In Patients With Targeted Advanced Solid Tumors And Hematological Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
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Using Virtual Community Health Workers To Connect Patients To Cancer Research Studies
Jacksonville, FL
The purpose of this study is to quantitatively examine, via a post-test only survey, a tailored intervention utilizing virtual human technology (VHT) to improve communication with rural and ethnic/racial minority patients and their willingness to participate in clinical research as an ultimate means to increase the diversity of NCI-sponsored clinical trials (CCTs).
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A Study to Evaluate the Safety and Tolerability of HMPL-306 to Treat Advanced or Metastatic Solid Tumors with IDH Mutations
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
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Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Jacksonville, FL
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer
No Locations
This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single agent and in combination with enzalutamide, as well as determine the maximum tolerated dose (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: - In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) - ...
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Collection and Storage of Tissue and Blood Samples From Patients With Cancer
Rochester, MN
This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.
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A Study to Evaluate the Impact of a Pharmacist-led Oral Anticancer Medication (OAM) Program on Patient Outcomes
La Crosse, WI
The purpose of this study is to evaluate the impact of integrating a pharmacist-led OAM education program within the interdisciplinary oncology team at the Stephen and Barbara Slaggie Family Cancer Center and Blood Disorders Center within Mayo Clinic Health System – La Crosse.
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A Study to Evaluate AL102 to Treat Patients with Progressing Desmoid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of AL102 in patients with progressive desmoid tumors.
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Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score
Albert Lea, MN; Rochester, MN; Jacksonville, FL
The puporse of this trial is to compare less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses ...
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Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
Rochester, MN
The purpose of this study is to find the maximum tolerated dose of iberdomide for patients newly diagnosed with multiple myeloma, and to determine response rate during induction treatment when combined with daratumumab, bortezomib and dexamethansone.
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A Study To Evaluate Oncologic Outcomes And Quality Of Life In Sinonasal Cancer Patients
Rochester, MN
This is a multi-site study with several other leading centers studying sinonasal cancers. The purpose of this study is to gain a better understanding of the treatment and significant morbidity associated with sinonasal cancer and identify the impact this disease has on quality of life. In addition, several additional endpoints will focus on survival and optimal treatment strategies. Additional components will also included genomic and molecular analysis of tumor tissue as we search for novel targets for therapy.
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A Study Of SPX-303, A Bispecific Antibody Targeting LILRB2 And PD-L1 In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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PSMA PET For Metastatic Adenoid Cystic Carcinoma (ACC)
Rochester, MN
The purpose of this study is to evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
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Gut Microbiome In Solid Tumor Management
Rochester, MN
The purpose of this research is to study the impact of the bacteria in the intestine (gut) on the efficacy and side effects of the anticancer therapies.
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Equity Of Cancer Screening And Follow-up For Lung Cancer
Rochester, MN
The purpose of this study is to elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: (1) Characterize the delivery of evidence-based interventions (EBIs) for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening (LCS) at multiple levels of influences; (2) Identify potentially modifiable care gaps across the LCS continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients ...
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Scottsdale/Phoenix, AZ
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). ...
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A Study to Assess Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Rochester, MN
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the ...
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Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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Study of Cell-surface Proteins in Renal Tumors for Future Exploration of New Anticancer Therapies
Rochester, MN
In this study, we propose to use a combination of cell-surface capture and mass spectrometry on patient tumors to identify tumor-associated cell-surface proteins that are targetable with next-generation immunotherapies. These therapeutic antibodies and their derivatives have transformed the therapeutic landscape of cancer patients. Only 20% of cell-surface proteins have been investigated so far for drug development. Untargeted proteomics has been the gold standard to identify tumor-associated proteins. However, it suffers from low sensitivity for cell-surface proteins. Cytosolic proteins are much more abundant and soluble than cell-surface proteins which results in limited resolution of the entire cell-surface proteome.
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JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and/or refractory multiple myeloma.
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Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Rochester, MN
This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.
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Study of rSIFN-co for Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, disease response, and drug /body interactions of rSIFN-co at different dose levels to demonstrate optimal dosage for patients with advanced solid tumors.
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Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
Rochester, MN
This phase II trial studies how well glembatumumab vedotin works in treating patients with middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the body (metastatic) or has returned at or near the same place after a period of time during which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink the tumor by binding to tumor cells and delivering tumor-killing substances to them.
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Melanoma In-transit Tissue Bank and Molecular Analysis for Personalized Therapies
Rochester, MN; Jacksonville, FL
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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A Study of AO-176 as Monotherapy Combinated with Bortezomib and Dexamethasone in Adults with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AO-176, including dose-limiting toxicities (DLT), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) when administered as monotherapy, and in combination with dexamethasone (AO-176+DEX) in adult patients with Relapsed/Refractory Multiple Myleoma (R/R MM).
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
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VSV-hIFNbeta-NIS in Treating Patients With Stage IV or Recurrent Endometrial Cancer
Rochester, MN
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells.
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A Trial of ZL-1201 in Subjects with Advanced Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
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Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Scottsdale/Phoenix, AZ
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD
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An Open-label, Phase 2 Basket Study of Neratinib in Patients with Solid Tumors with Somatic Activating HER Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the effectiveness and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.
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Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Rochester, MN
The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.
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A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of MT-0169 and establish the MTD (maximum tolerated dose)/ RP2D (recommended phase 2 dose). Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease. The study will also examine how the body handles MT-0169. This will be done by looking at the pharmacokinetics of MT-0169after a single dose and after repeat doses in people ...
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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Real-time Disease Monitoring of Metastatic Breast Cancer to Optimize Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to identify subtype-specific signatures for breast cancer using genomic positioning of plasma DNA fragments, and to validate changes in ctDNA levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.
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A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of TAB001 in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2) evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4) evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of TAB001, 2) evaluate the utility of PD-L1 & ...
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A Study to Assess the Safety, Tolerability, and Effectiveness of KPT-9274 to Treat Patients who have Advanced Solid Malignancies or Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.
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A Study of the Safety, Effectiveness and Maximum Tolerated Dose of Oral PQR309 for Patients with Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
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Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
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Pragmatic Comparative Clinical Trial to Determine Optimal Initial Therapy for Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed Multiple Myeloma.
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A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway
Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX0902 as monotherapy or in combination with selected cancer therapeutic agents in patients having advanced solid tumor malignancies harboring mutations in the KRAS-MAPK pathway.
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Molecular Analysis To Drive Individualized Care In Lung Cancer
Rochester, MN
The purpose of this study is to determine if robotic biopsies provide sufficient material for whole genomics and transcriptomics, transcriptome anomalies are confined to tumor cells as opposed to background lung parenchyma, and whole genomics may provide further pathologic insight in cases where de novo primary may be difficult to discern from metastatic disease.
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Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Jacksonville, FL
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
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Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate
Rochester, MN
The purpose of this study is to develop tests for early detection of lung cancer or lung fibrosis based on multiomics analyses of patients’ breath condensates.
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177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.
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A Study to Collect Surgical Tumor Samples for Prostate Cancer-derived Tissue Graft
Rochester, MN
The purposes of this study are to collect prostate surgical samples from metastatic patients to establish xenograft tumor lines for future testing of potential therapies and for understanding mechanisms of therapy resistance via DNA/RNA sequencing, to collect patient blood samples for future DNA/RNA sequencing , and to collect patient urine samples for future prostate cancer related biomarker detection and DNA/RNA sequencing.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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A Study to Evaluate Infigratinib to Treat Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of infigratinib in approximately 218 adult subjects with invasive urothelial carcinoma with susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements]; hereafter referred to collectively as "FGFR3 alterations") who are within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy and ineligible for cisplatin-based (neo)adjuvant chemotherapy or with residual disease after neoadjuvant therapy.
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A Study to Evaluate the Safety, Effectiveness and Tolerability of APG-2575 in Patients with Waldenström Macroglobulinemia
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-2575, alone or in combination with other therapeutic agents (ibrutinib or rituximab), in patients with Waldenström Macroglobulinemia (WM).
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In Vitro 3D Cell Culture Models Validation for Tumor Drug Sensitivity after Tissue Removal
Rochester, MN
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the rate of sustained MRD negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.
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A Study Of The Pan-KRAS Inhibitor LY4066434 In Participants With KRAS Mutant Solid Tumors
Scottsdale/Phoenix, AZ
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
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Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
Rochester, MN; Jacksonville, FL
The purpose of this early feasibility study (EFS) is to evaluate the safety of delivering Aliya pulsed electric fields ablation in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
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Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
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A Study To Evaluate ARV-806 In Adults With Advanced Cancer That Has The KRAS G12D Mutation
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is ...
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Study To Improve Health-related Quality Of Life (HRQOL) In Black Prostate Cancer Patients (CaPQoL) Through Whole Person Survivorship Care
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.
Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, ...
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A Study Of Tolododekin Alfa (ANK-101) In Combination With An Anti-PD-1/PD-L1 Antibody In Participants With Advanced Non-Small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
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Patient Perspectives on Bladder Cancer Care
Jacksonville, FL; Rochester, MN
The purpose of this study is to explore thoughts and experiences of bladder cancer patients who underwent radical cystectomy at Mayo Clinic Florida through qualitative interviews.
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Testing For Spread Of Stomach Cancer To Abdominal Cavity
Rochester, MN
The purpose of this study is to establish a clinical useful gene expression panel for detecting and predicting peritoneal relapse and survival to address the unmet clinical need for a simple and accurate staging of the peritoneum in gastric cancer.
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A Study To Learn How Research Sites Successfully Recruited To A Geriatric Oncology Trial That Relied On Electronic Patient-reported Outcomes (EPRO)
Rochester, MN
The purpose of this study is to analyze how research sites successfully recruit geriatric oncology patients using electronic-reported patient outcomes.
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Understanding Treatment Preferences In Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this research is to understand how people with lymphoma make decisions about treatment and why. Study participation involves partaking in one virtual focus group session with a group of up to 8 people with lymphoma and up to two group moderators. Participants will be asked questions about what they prefer in a lymphoma treatment and how they have made decisions on treatment of their lymphoma in the past. Questions may be about past experiences as well as future hypothetical situations. We hope that what we learn from these discussions will help us to improve care for people ...
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Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that is recurrent, metastatic, or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, can interfere with tumor growth by blocking the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.
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A Study to Assess the Effectiveness, Safety, and Drug/Body Interactions of Rovalpituzumab for Third-Line and Later Treatment of Patients with Small Cell Lung Cancer that has Returned or is Resistant to Treatment
Rochester, MN
The purpose of this study is to determine the effectiveness, safety, and drug/body interactions of rovalpituzumab tesirine as a third-line or later treatment for patients who have small cell lung cancer that has returned or is resistant to other treatments.
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Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.
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Defibrotide for Patients with Hepatic Veno-occlusive Disease: A Treatment IND Study
Rochester, MN
Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.
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Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients with Advanced Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.
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Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia
No Locations
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma
Rochester, MN
The purpose of this study is to develop and validate a new disease-specific, quality-of-life (QOL) index for sporadic Vestibular Schwannoma (VS) that addresses key shortcomings of previous instruments.
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PSMA PET For Metastatic Adenoid Cystic Carcinoma (ACC)
Rochester, MN
The purpose of this study is to evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
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Gut Microbiome In Solid Tumor Management
Rochester, MN
The purpose of this research is to study the impact of the bacteria in the intestine (gut) on the efficacy and side effects of the anticancer therapies.
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Equity Of Cancer Screening And Follow-up For Lung Cancer
Rochester, MN
The purpose of this study is to elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: (1) Characterize the delivery of evidence-based interventions (EBIs) for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening (LCS) at multiple levels of influences; (2) Identify potentially modifiable care gaps across the LCS continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients ...
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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Study of rSIFN-co for Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, disease response, and drug /body interactions of rSIFN-co at different dose levels to demonstrate optimal dosage for patients with advanced solid tumors.
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Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
Rochester, MN
This phase II trial studies how well glembatumumab vedotin works in treating patients with middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the body (metastatic) or has returned at or near the same place after a period of time during which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink the tumor by binding to tumor cells and delivering tumor-killing substances to them.
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Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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A Study to Estimate the Clinical Benefit of REGN2810 for Patients with Advanced Squamous Cell Skin Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the clinical benefit of REGN2810 for patients who have metastatic (in lymph nodes or distant) squamous cell skin cancer or locally advanced squamous cell skin cancer that cannot be removed with surgery.
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SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Scottsdale/Phoenix, AZ
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). ...
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A Study to Assess Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Rochester, MN
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the ...
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Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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Study of Cell-surface Proteins in Renal Tumors for Future Exploration of New Anticancer Therapies
Rochester, MN
In this study, we propose to use a combination of cell-surface capture and mass spectrometry on patient tumors to identify tumor-associated cell-surface proteins that are targetable with next-generation immunotherapies. These therapeutic antibodies and their derivatives have transformed the therapeutic landscape of cancer patients. Only 20% of cell-surface proteins have been investigated so far for drug development. Untargeted proteomics has been the gold standard to identify tumor-associated proteins. However, it suffers from low sensitivity for cell-surface proteins. Cytosolic proteins are much more abundant and soluble than cell-surface proteins which results in limited resolution of the entire cell-surface proteome.
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JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Rochester, MN
This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.
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Phase III Copanlisib in Rituximab-refractory iNHL
Rochester, MN
Assess the efficacy and safety of copanlisib monotherapy
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Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy
Rochester, MN; Albert Lea, MN; Mankato, MN
The primary purpose of this study is to evaluate whether topical CBD improves chemotherapy-induced peripheral neuropathy (CIPN), compared to placebo, and to evaluate side effects from topical CBD cream use, compared to placebo.
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Study of MK-8242 Alone and in Combination with Cytarabine in Participants with Acute Myelogenous Leukemia (P07649)
Scottsdale/Phoenix, AZ; Rochester, MN
This is a study of MK-8242 alone and in combination with cytarabine in adult participants with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms. Arm A is for participants with refractory or recurrent AML who are considered ineligible for standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy. Arm B is for participants with recurrent AML following an initial complete remission (CR) or ...
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Cancer screening practices of individuals with Lynch Syndrome
Rochester, MN
This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
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A Study to Evaluate Gleolan to Enhance Tumor Visualization in Patients with Newly-diagnosed or Recurrent Meningioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX).
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A Study To Investigate Efficacy & Safety Of Intratumoral INT230-6 Compared To US Standard Of Care In Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.
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A Study to Evaluate the Effectiveness and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects with Mycosis Fungoides
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the effectiveness and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.
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Evaluation of the Value of Exosomal DEL-1 and miRNA Levels as Biomarkers for Breast Cancer
Jacksonville, FL
The purpose of this study is to measure DEL-1 levels and develop and validate methods for measurement of the exosomal T-RNAs( miR 1274b and mirR 720) as well as four miRs ( miR 21, let-7a, miR 125b and miR 100) in pre and post tumor resection plasma samples from women with newly diagnosed localized breast cancer.
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Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and/or refractory multiple myeloma.
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A Study to Evaluate the Effectiveness and Safety of Cobomarsen (MRG-106) in Subjects with Mycosis Fungoides Who Have Completed the SOLAR Study
Scottsdale/Phoenix, AZ
The main purpose of this study is to evaluate the effectiveness and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time ...
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Global Trial in APG2575 for Patients With CLL/SLL
Jacksonville, FL
The purpose of this study is to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
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A Study to Analyze the Safety and Effectiveness of the NanoKnife® System in Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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Cancer-Related Fatigue Amongst Cutaneous Oncology Patients
Rochester, MN
The purpose of this study is to identify the severity of cancer-related fatigue (CRF) amongst cutaneous oncology patients within the dermatologic surgery department at Mayo Clinic Rochester. We aim to delineate the spectrum of CRF as it relates to tumor incidence and patient perception of incidence.
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Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).
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Metastatic Leiomyosarcoma Biomarker Protocol
Rochester, MN; Jacksonville, FL
The primary objectives of this study are to examine the correlation of change in ctDNA with objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), and to examine the correlation of change in ctDNA with progression free survival (PFS).
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Study of INBRX-109 in Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients With Advanced or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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A Study To Compare Standard Therapy To Treat Hodgkin Lymphoma To The Use Of Two Drugs, Brentuximab Vedotin And Nivolumab
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL who have a rapid early response (RER) as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy. Also, to compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles ...
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Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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Phase 2 Study with TTI-622 and TTI-621 in Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of ths study is to find out more about the side effects of two new drug combinations for lymphoma, TTI-621 and pembrolizumab and TTI-622 and pembrolizumab, and what doses of TTI-621 and TTI-622 are safe for people to take. In addition, we want to learn if the drug combinations help your cancer.
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A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) by IRR of ripretinib vs sunitinib using modified Response Evaluation Criteria in Solid Tumors v1.1 – GIST-specific (mRECIST). Also, to compare the overall survival (OS) of ripretinib vs sunitinib.
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A Study to Explore Tumor Biology in Metastatic Esophageal and Gastric Cancer Patients
Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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Financial Toxicity Among Patients In Phase I Clinical Trials
Rochester, MN
As medical care in the United States becomes increasingly expensive, cost stewardship is a necessary component of delivering high value care. Cancer patients require additional protection from unmanageable costs, as the average out of pocket (OOP) cost during the first month of diagnosis is as high as $2900. Financial toxicity (FT) describes the adverse impact that the cost of treatment imposes upon our patients. Over the last five years, FT has become a well-recognized adverse impact of a cancer diagnosis. FT not only decreases the patient's quality of life, but also patients who file bankruptcy during cancer treatment ...
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Rochester, MN
The purpose of this study is to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, Also, to assess the Duration of Response (DOR) 6 months from initial response.
Additionally, to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
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A Study of NB003 in Patients With Advanced Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of NB003 in subjects with Advanced Solid Tumors.
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Solitary Bone Plasmacytomas to Elucidate Their Pathogenesis and Risk of Progression to Multiple Myeloma
Rochester, MN
The purpose of this study is to obtain archived residual formalin-fixed-paraffin-embedded tissue from diagnostic biopsies of solitary bone plasmacytomas for cytogenetic and proteomic testing followed by correlations to their radiographic and clinical features. Clinical, radiographic, and laboratory features of solitary bone plasmacytomas will be evaluated to determine if they can define patients at risk of rapidly progressing to multiple myeloma.
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Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Rochester, MN
The purpose of this study is to evaluating the clinical outcomes of grid therapy.
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Quality of life in older adults with lymphomas
Scottsdale/Phoenix, AZ
The purpose of this study is to identify factors important to decision-making for older adults with indolent lymphomas and to identify minimum clinically significant differences in QOL domains are important to older patients in their decision-making about clinical management. And to characterize longitudinal health-related quality of life (QOL) for older adults with indolent lymphomas.
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A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.
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Immune Response to Antigens
Jacksonville, FL
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
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Risk Stratified De-escalated De-intensified Treatment for High Risk Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.
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Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.
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BCL2 Inhibitor Venetoclax With Daratumumab-Lenalidomide-Dexamethasone Or Venetoclax-Rd for Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose Dd combination (Arm A), Rd combination (Arm B) or daratumumab, lenalidomide and dexamethasone (Arm C) in patients with newly diagnosed t(11;14) multiple myeloma (MM).
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Loneliness in Cancer Patients: A Qualitative Study
Rochester, MN
The purpose of this study is to characterize, using the patients’ own words, the experience of loneliness (or lack of privacy) that may be felt on inpatient units.
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Sarcopenia Impact Among Older Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between baseline sarcopenia and high-grade chemotherapy toxicity during the first 4 cycles of treatment measured by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0, the Patient-Reported Outcomes (PRO) version of the CTCAE(PRO-CTCAE), and treatment discontinuation in older patients (≥60 years) with hematologic malignancies.
The hypothesis is that for older patients with hematologic malignanclies, sarcopenia is associated with higher likelihood of high-grade treatment-related chemotherapy toxicity and a higher rate of treatment discontinuation during the first 4 cycles of treatment.
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A Study to Assess the Safety and Dose Escalation of Pegtomarginase (PT01) for Subjects with Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of PT01 administered intravenously in subjects with advanced malignancies.
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A Study to Evaluate ION251 to Treat Patients with Relapsed/Refractory Multiple Myleoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.
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CC-4047 in Treating Patients With Myelofibrosis
Rochester, MN
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer cells by blocking blood flow to the cancer.
PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well it works in treating patients with myelofibrosis.
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GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Rochester, MN
The purpose of this study is to evaluate whether CAN-2409 + prodrug added to standard of care immune checkpoint inhibitor (ICI) therapy will be safe and improve the outcome for Non-small Cell Lung Cancer (NSCLC) patients that have stable disease or readiographic progression after at least 18 weeks of ICI therapy or that have refractory disease after at least 9 weeks of ICI therapy.
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Sym021 in Combination with Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients with Advanced Biliary Tract Carcinomas
Rochester, MN
The purpose of this study is to evaluate the preliminary effectiveness of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan) in Biliary Tract Cancer by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. This study will also evaluate the safety and tolerability profile of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan).
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Study of Molecular Circulatory Biomarkers in Hormone Sensitive and Castration Recurrent Prostate Cancer
Rochester, MN
The purpose of this study is to collect blood and urine samples from men already diagnosed with advanced prostate cancer. The blood and urine specimens obtained from you and other participants during this research will be processed to look for proteins, protein products and genetic markers of cancer and its treatments that may have been shed in blood and urine specimens you volunteer to donate. These markers can potentially guide us to give specific treatments to the patients in future and also to develop "precision medicine". This way we increase the chance for the drugs to be effective and limit ...
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KTX-100 MMSET Catalytic Inhibitor that Suppresses H3K36me2 in Patients with Relapsed and Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and schedule and/or a recommended Phase 2 dose (RP2D) and schedule of KTX-1001 for patients with relapsed and refractory multiple myeloma.
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Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Rochester, MN
Primary Objectives In the Dose Escalation Phase:
- To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.
In the Dose Expansion Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Objectives In the Dose Escalation Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR ...
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Study of CPI-0610 in Myelofibrosis (MF)
Jacksonville, FL
This study aims to determine the efficacy of CPI-0610 + ruxolitinib compared with placebo + ruxolitinibin patients with naive myelofibrosis (MF).
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A study of how current treatments impact the course of relapsed myeloma and the effect of the treatments on the quality-of-life measurements.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine the impact of standard of care therapies for TCR MM, in a real-world setting, on patient-reported symptoms, functioning, and QoL, measured prospectively using questionnaires. The secondary goal is to asses clinical endopoints associated with standard of care therapies for TCR MM, in a real-world setting during 12 months of observation.
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A Study of Vesicles, Prostate Cancer
Rochester, MN
The purpose of this study is to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) and circulating tumor DNA (ctDNA) across time and treatments.
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A Study To Investigate ALE.P02 As Monotherapy In Adult Patients With Selected CLDN1+ Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
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A Study To Follow Durability Of Patient Responses From Studies UT001 And TC-BC-12
Jacksonville, FL; Rochester, MN
The purposes of this study are to determine the durability of response in patients with low grade upper tract urothelial carcinoma (LG-UTUC) treated with JELMYTO in Study UT001 who completed the study with a durable response, and the durability of response in patients with low grade non-muscle invasive bladder cancer (LG-NMIBC) treated with UGN-102 in Study TC-BC-12 who completed the study with a durable response.
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A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma
Scottsdale/Phoenix, AZ
Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
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Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Rochester, MN; Mankato, MN
The purpose of this study is to conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
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A Safety Study of SGN-CD19A for Leukemia and Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).
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Combination of Serabelisib and Insulin Suppressing Diet in Subjects With Advanced Solid Tumors with PIK3CA Mutations
Rochester, MN
The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.
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Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of Perampanel on seizure frequency in adult patients with brain-tumor with and without seizures associated with glioma.
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A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL. MOR00208 is an investigational drug. RTX and BEN are both approved in many countries for the treatment of lymphomas. The combination of both is considered and recommended by some medical authorities in some other countries as an option to treat DLBCL.
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Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
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Validation of a Blood Assay for the Detection of BRAF Mutation Status in Patients with Metastatic Melanoma
Rochester, MN
The purpose of this study is to validate an internally developed assay for the detection of BRAF V600E mutations in cfDNA from the peripheral blood of patients with melanoma.
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A Study to Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs to Treat Patients with Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
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The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
Rochester, MN
The purpose of this study is to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials.
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Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery
Rochester, MN
The objective of this study is to determine intensity of I-123 uptake in follicular thyroid lesions before surgery and correlate with final pathology findings.
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A Study to Evaluate the Effectiveness and Safety of P276-00 for Mantle Cell Lymphoma that has Returned and/or is Resistant to Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.
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A Study Using Momelotinib in Transfusion-Dependent Adults with Primary Myelofibrosis, Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This study will evaluate the transfusion independence response rate in transfusion-dependent adults with myelofibrosis following treatment with momelotinib.
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Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous ...
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A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
Rochester, MN
The primary objectives for this study are to compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and/or 2nd line metastatic pancreatic cancer patients, and to determine which, if any, patients benefit from each investigational arm.
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A Study to Evaluate the Safety and Effectiveness of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
Rochester, MN
The purpose of this 2 cohort study is to evaluate the effectiveness of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 in whom first line outcome data are available and (2) matched control HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first ...
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Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (MANTRA)
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.
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A Study to Evaluate the Effectiveness and Safety of Rivaroxaban as Prophylaxis Treatment for Venous Thromboembolism (VTE) in Ambulatory Cancer Patients
Rochester, MN
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult patients with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
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A Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Basal Cell Nevus Syndrome (BCNS; Gorlin Syndrome).
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Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of SP-2577 (seclidemstat) as a single agent and in combination with topotecan and cyclophosphamide (TC) in patients with relapsed or refractory Ewing sarcoma and select sarcomas.
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A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
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A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the effectiveness and safety of Momelotinib (MMB) to Danazol (DAN) in treating and reducing disease related symptoms, the need for blood transfusions, and splenomegaly, in adults with primary Myelofibrosis (MF), post-polycythemia vera MF or post-essential thrombocythemia MF.
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to c The study ...
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Hairy Cell Leukemia Patient Data Registry
Rochester, MN
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 600 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends ...
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A Study to Assess Safety and Effectiveness of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The purpose of this dose-escalation study is to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of venetoclax, in combination with gilteritinib, in subjects with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
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A Study to Evaluate the Effectiveness and Safety of Pemigatinib in Previously-treated, Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of pemigatinib in participants with previously-treated, locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
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Clinical Features, Prognostic Factors, Local Control Modalities, Survival, and Outcomes of Ewing Sarcoma in Pediatric and Adult Patients
Rochester, MN
The purpose of this study is to compare clinical features and outcomes for children and adults with Ewing Sarcoma at the same institution and add to the limited clinical literature on adults with Ewing Sarcoma.
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Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
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A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383.
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Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of a ddPCR assay for the detection of mutations associated with uveal melanoma. The performance characteristics of the ddPCR assay for the detection of ctDNA mutation in uveal melanoma patients will be assessed by comparing the mutation results obtained for the ddPCR assay on blood to those obtained on paired paraffin embedded tumors.
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Long-term Follow Up of Patients Previously Enrolled in MC1137 (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to extend the follow up on the BEAUTY study (MC1137) cohort and collect additional blood samples to evaluate for minimal residual disease and tissue at the time of any breast cancer recurrence.
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A Study to Evaluate the Development of Patient Derived Xenografts in Patients With Breast Cancer
Rochester, MN
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).
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Metastatic Leiomyosarcoma Biomarker Protocol
Rochester, MN; Jacksonville, FL
The primary objectives of this study are to examine the correlation of change in ctDNA with objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), and to examine the correlation of change in ctDNA with progression free survival (PFS).
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Study of INBRX-109 in Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients With Advanced or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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A Study To Compare Standard Therapy To Treat Hodgkin Lymphoma To The Use Of Two Drugs, Brentuximab Vedotin And Nivolumab
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL who have a rapid early response (RER) as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy. Also, to compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles ...
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Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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Phase 2 Study with TTI-622 and TTI-621 in Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of ths study is to find out more about the side effects of two new drug combinations for lymphoma, TTI-621 and pembrolizumab and TTI-622 and pembrolizumab, and what doses of TTI-621 and TTI-622 are safe for people to take. In addition, we want to learn if the drug combinations help your cancer.
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A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) by IRR of ripretinib vs sunitinib using modified Response Evaluation Criteria in Solid Tumors v1.1 – GIST-specific (mRECIST). Also, to compare the overall survival (OS) of ripretinib vs sunitinib.
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A Study to Explore Tumor Biology in Metastatic Esophageal and Gastric Cancer Patients
Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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Financial Toxicity Among Patients In Phase I Clinical Trials
Rochester, MN
As medical care in the United States becomes increasingly expensive, cost stewardship is a necessary component of delivering high value care. Cancer patients require additional protection from unmanageable costs, as the average out of pocket (OOP) cost during the first month of diagnosis is as high as $2900. Financial toxicity (FT) describes the adverse impact that the cost of treatment imposes upon our patients. Over the last five years, FT has become a well-recognized adverse impact of a cancer diagnosis. FT not only decreases the patient's quality of life, but also patients who file bankruptcy during cancer treatment ...
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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Phase 2 Study of VGT-309 in Lung Cancer
Rochester, MN
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
Scottsdale/Phoenix, AZ
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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Clinicopathological and Molecular Characteristics Associated With Acquired Resistance to Kinase Inhibitors in Thyroid Cancer
Rochester, MN
Objectives
The purpose of this study is to understand the clinicopathological and molecular characteristics associated with acquired resistance to kinase inhibitors in thyroid cancer.
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Ulixertinib in People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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Investigating Memory and Physical Activity after Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).
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Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer that has been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment ...
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A Study to Analyze the Association Between Financial and Health Insurance Literacy and Financial Distress in Patients Being Treated for Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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A Study to Assess the Effectiveness and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Study of MK-1026 in Patients with Selected Hematologic Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Testing Low Dose Tamoxifen For Invasive Breast Cancer, The (LoTam) Trial
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to ...
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Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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CJNJ-67652000 And Prednisone For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer And SPOP Gene Mutations
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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A Study Of Home-Based Therapy For Glioma
Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the feasibility of the remote chemotherapy management and patient monitoring platform GHoST Protocol among patients with glioma undergoing systemic therapy.
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NBTXR3 With or Without Cetuximab LA-HNSCC
Jacksonville, FL
The purpose of this study is to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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INCB039110 Combined With INCB024360 and/or INCB039110 Combined With INCB050465 in Advanced Solid Tumors
Rochester, MN
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 2 parts (Part 1a and Part 1b). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (INCB039110) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and INCB039110 in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion ...
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Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155)
Rochester, MN
This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites. During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose ...
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A Trial of TTI-621 for Patients With Hematologic Malignancies and Selected Solid Tumors
Rochester, MN; Jacksonville, FL
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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Safety Study of VAL-083 in Patients with Recurrent Malignant Glioma
Rochester, MN
The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
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A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Scottsdale/Phoenix, AZ
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.
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Phase 1/2 Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
Rochester, MN
Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD, and clinical activity evaluation of orally administered AG-221 in subjects with advanced hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical activity of AG-221 in select populations.
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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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Study of AMG 650 in Adult Participants With Advanced Solid Tumors
Rochester, MN
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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International Hepatobiliary Neoplasia Registry and Biorepository
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This study is being done to:
1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.
2. A second purpose of this study is to obtain blood and tissue samples from participants ...
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A Study to Evaluate the Effectiveness, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV).
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A Study Evaluating the Effectiveness of Oral Vismodegib in Various Histologic Subtypes of High Risk or Locally Advanced Basal Cell Carcinoma
Jacksonville, FL
The purpose of this study is to investigate the safety and effectiveness of oral vismodegib therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC). The term 'histologic subtype' refers to how the cells and tumor tissue looks under the microscope. Three different 'histologic subtypes' of basal cell skin cancer (infiltrative/morpheaform, nodular and superficial) will be examined in this study.
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working.
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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A Safety Study of SEA-TGT (SGN-TGT) in Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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A Study to Assess Financial Burden and Its Impact on Quality of Life in Patients with Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Study to Evaluate the Safety, Tolerability and Preliminary Antitumor Activity of INCB059872 in Patients with Relapsed/Refractory Ewing Sarcoma
Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.
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A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study to Evaluate Feasibility of In Vivo Sensitivity Screen Using Direct Tumor Microinjection and FDG-PET in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of Phase I of this study is to evaluate the safety and tolerability of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) / higher risk myelodysplastic syndromes (HR-MDS) / MDS/MPN to determine the recommended dose of CTX-712. The purpose of Phase II of this study is to assess the effiectiveness of CTX-712 in patients with R/R AML/HR-MDS by determination of complete remission (CR) rates.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.
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Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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Once-daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
Jacksonville, FL
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide or abiraterone.
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Cardio-Oncology Clinic Registry
Rochester, MN
The purpose of this study is to establish a retrospective and prospective clinical registry of patients seen in the cardio-oncology clinic to characterize trends in the composition and outcomes of the population seen in the clinic, as well as initial clinical analyses on cardiovascular toxicities.
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ICCaRE Consortium Pilot Project 1: Feasibility Of A Point Of Prostate Cancer Diagnosis Intervention For Newly Diagnosed Black Men
Jacksonville, FL
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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Study of Ociperlimab in Combination With Tislelizumab in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objectives of this study are to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion.
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Solid Tumor Monoclonal B-cell Lymphocytosis Screening
Rochester, MN
The purpose of this study is to determine whether monoclonal B-cell lymphocytosis (MBL) has an impact on clinical outcomes among patients with a diagnosis of a solid tumor.
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A Study to Determine Baseline Levels for Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
Rochester, MN
The purposes of this study are to determine the levels of prostate cancer-derived extracellular vesicles pre- and post-local therapy (radical prostatectomy or radiation therapy), to correlate analysis for PSA levels and prostate cancer-derived extracellular vesicles, and to determine baseline levels of prostate cancer-derived extracellular vesicles in patients undergoing different lines of primary local treatment.
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FT576 in Subjects With Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the recommended phase II dose for FT576 when administered as monotherapy and in combination with daratumumab, and to evaluate the safety and tolerability of FT576 when administered as monotherapy and in combination with daratumumab
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Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP Deletion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography for Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer
Jacksonville, FL
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may ...
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Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Rochester, MN
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
We would like to see if use of topical ketoconazole will improve rashes in patients with EGFR inhibitor-induced rash.
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A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), ...
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Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected Non-Small Cell Lung Cancer.
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A Phase 1 Study Of XL309 (ISM3091) Alone And In Combination In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.
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Perceived Financial Hardship in Patients with Multiple Myeloma and Their Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to examine the agrrement in perception of finacial hardship (FH) and the perceived stress in patients with multiple myeloma (MM) and their caregivers (CG). Additionally, we will describe protective buffering/emotional disclosure in patients with MM and their CGs and examine their association with FH, and perceived stress.
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Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Rochester, MN
The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
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Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).
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Viral Therapy In Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer or Metastatic Breast Cancer
Rochester, MN
This phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
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Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
Scottsdale/Phoenix, AZ
This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the ...
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Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
Rochester, MN
The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.
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Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in NMIBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer
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A Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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A Comprehensive Translational Research Platform for Colorectal Cancer
Rochester, MN
The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or ...
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Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Rochester, MN; Jacksonville, FL
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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International Hepatobiliary Neoplasia Registry and Biorepository
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This study is being done to:
1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.
2. A second purpose of this study is to obtain blood and tissue samples from participants ...
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A Study to Evaluate the Effectiveness, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV).
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A Study Evaluating the Effectiveness of Oral Vismodegib in Various Histologic Subtypes of High Risk or Locally Advanced Basal Cell Carcinoma
Jacksonville, FL
The purpose of this study is to investigate the safety and effectiveness of oral vismodegib therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC). The term 'histologic subtype' refers to how the cells and tumor tissue looks under the microscope. Three different 'histologic subtypes' of basal cell skin cancer (infiltrative/morpheaform, nodular and superficial) will be examined in this study.
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SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Study to Evaluate the Safety, Tolerability and Preliminary Antitumor Activity of INCB059872 in Patients with Relapsed/Refractory Ewing Sarcoma
Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.
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Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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A Study of Cemiplimab in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Scottsdale/Phoenix, AZ
The primary objective is to estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with Cemiplimab as a monotherapy.
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A Study of XmAb ®18087 in Subjects With NET and GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and tolerability profile of XmAb18087 in subjects with advanced, well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST), and to identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on Days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET and advanced GIST, separately.
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Safety Study of SEA-TGT (SGN-TGT) in Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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A Study to Assess Financial Burden and Its Impact on Quality of Life in Patients with Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Study of AMG 650 in Adult Participants With Advanced Solid Tumors
Rochester, MN
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working.
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study to Evaluate Feasibility of In Vivo Sensitivity Screen Using Direct Tumor Microinjection and FDG-PET in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of Phase I of this study is to evaluate the safety and tolerability of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) / higher risk myelodysplastic syndromes (HR-MDS) / MDS/MPN to determine the recommended dose of CTX-712. The purpose of Phase II of this study is to assess the effiectiveness of CTX-712 in patients with R/R AML/HR-MDS by determination of complete remission (CR) rates.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
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Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
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Pragmatic Comparative Clinical Trial to Determine Optimal Initial Therapy for Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed Multiple Myeloma.
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A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway
Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX0902 as monotherapy or in combination with selected cancer therapeutic agents in patients having advanced solid tumor malignancies harboring mutations in the KRAS-MAPK pathway.
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Molecular Analysis To Drive Individualized Care In Lung Cancer
Rochester, MN
The purpose of this study is to determine if robotic biopsies provide sufficient material for whole genomics and transcriptomics, transcriptome anomalies are confined to tumor cells as opposed to background lung parenchyma, and whole genomics may provide further pathologic insight in cases where de novo primary may be difficult to discern from metastatic disease.
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Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Jacksonville, FL
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
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Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate
Rochester, MN
The purpose of this study is to develop tests for early detection of lung cancer or lung fibrosis based on multiomics analyses of patients’ breath condensates.
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177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.
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A Study to Collect Surgical Tumor Samples for Prostate Cancer-derived Tissue Graft
Rochester, MN
The purposes of this study are to collect prostate surgical samples from metastatic patients to establish xenograft tumor lines for future testing of potential therapies and for understanding mechanisms of therapy resistance via DNA/RNA sequencing, to collect patient blood samples for future DNA/RNA sequencing , and to collect patient urine samples for future prostate cancer related biomarker detection and DNA/RNA sequencing.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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A Study to Evaluate Infigratinib to Treat Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of infigratinib in approximately 218 adult subjects with invasive urothelial carcinoma with susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements]; hereafter referred to collectively as "FGFR3 alterations") who are within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy and ineligible for cisplatin-based (neo)adjuvant chemotherapy or with residual disease after neoadjuvant therapy.
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In Vitro 3D Cell Culture Models Validation for Tumor Drug Sensitivity after Tissue Removal
Rochester, MN
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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A Study to Evaluate the Safety, Effectiveness and Tolerability of APG-2575 in Patients with Waldenström Macroglobulinemia
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-2575, alone or in combination with other therapeutic agents (ibrutinib or rituximab), in patients with Waldenström Macroglobulinemia (WM).
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Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the rate of sustained MRD negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.
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A Study Of The Pan-KRAS Inhibitor LY4066434 In Participants With KRAS Mutant Solid Tumors
Scottsdale/Phoenix, AZ
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
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First in Human Study of TORL-4-500 in Participants With Advanced Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer
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InBody Band 3 Fitness Tracker to Improve Health Outcomes and Quality of Life in Black Prostate Cancer Survivors
Jacksonville, FL; Rochester, MN
The objective of this study is to test the acceptability and feasibility of combining a commercially available smartwatch, which tracks critical biometric data for the prediction of disease progression in individuals with cancer, with human feedback based on smartwatch activity data tailored to meet each patient’s needs.
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DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy in patients with advanced or metastatic solid tumors.
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Tools to evaluate treatment tolerability in older patients with sarcoma
Rochester, MN
Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated ...
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Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors
Rochester, MN
The purpose of this study is to determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.
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A Study of CMB305 and Atezolizumab in Patients with Sarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to examine the use of CMB305 in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein.
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Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Jacksonville, FL
The objectives of this study are to create a proteomic profile (Host Response) using plasma from patients before and after anti-cancer therapy, and to associate the changes in the levels of plasma proteins with response to treatment (ORR) as defined by RECIST 1.1 /other validated clinical scale to assess response.
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STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
Scottsdale/Phoenix, AZ
The main objective of this study is to describe and evaluate safety and effectiveness of MBG453 (sabatolimab) in combination with FDA approved Hypomethylating Agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI)).
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Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
Albert Lea, MN; Mankato, MN; Rochester, MN
This trial will be an evaluation of rose geranium in sesame oil nasal spray versus nasal saline. Rose geranium in sesame oil nasal spray is a compounded preparation, containing 0.2 mL (4 drops) of pharmaceutical grade rose geranium oil to 119.8 mL of pharmaceutical grade sesame oil and then put into 30mL bottles. This is the same compound that was used in the aforementioned study of patients with hereditary hemorrhagic telangiectasia (2). Isotonic nasal saline will contain 0.9% sodium chloride with benzalkonium chloride, as a preservative, in a 30 mL bottle.
Treatment duration
The therapy will ...
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Preclinical drug testing and assay development for lung adenocarcinoma characterized by the expression of ASCL1
Rochester, MN
The purpose of this study is to perform preclinical testing in patient samples and experimental models.
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A Study of Contribution of 3D Models in Resection of Renal Cell Cancer
Rochester, MN
The purpose of this study is to evaluate the impact on surgical planning and patient acceptance and understanding of 3D kidney tumor models prior to surgery.
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A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
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Social Determinants Of Migrant Health Factors Impacting Prostate Cancer Care And Survivorship Among Sub-Saharan African And Caribbean Immigrant Men
Rochester, MN
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.
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Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.
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FrαDcs Or Placebo For Patients With Advanced Stage Ovarian Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether vaccination with folate receptor alpha dendritic cells (FRalphaDCs) given to patients with advanced ovarian, fallopian tube, or primary peritoneal cancer can delay or prevent cancer recurrence, when compared with a placebo. FRalphaDCs are a vaccine made from patients' white blood cells that have been cultured in the laboratory to induce immune responses to the cancer.
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Mapping Patient-Centered Decision-Making In
Metastatic Cancer Care Delivery In Florida
Jacksonville, FL
The purpose of this study is to explore and describe metastatic breast cancer (mBC) and metastatic urothelial cancer (mUC) patient perspectives on and experiences with treatment decision-making, including how patients evaluate various treatment options, associated benefits, risks and drawbacks as well as how perceptions and preferences change over time.
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Zanzalintinib Versus Everolimus In Participants With Locally Advanced Or Metastatic Neuroendocrine Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
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Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of BL-M05D1 In Subjects With Solid Tumors
Scottsdale/Phoenix, AZ
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
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IFX_HU2.0 As An Adjunctive Therapy To Pembrolixumab In Checkpoint Inhibitor Naive Subjects With Advanced Or Metastatic Merkel Cell Carcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) between subjects treated with intralesional administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab, and subjects treated with placebo followed by pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Do Patients Diagnosed With Cancer Suffer From "scan-itis"?
Rochester, MN
The purpose of this study is to determine what patients experience when they return for scans or other testing during their oncology follow-up visits after their initial cancer diagnosis.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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Multiple Myeloma Patient Registry
Jacksonville, FL
The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.
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A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion.
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A Study to Examine the Effect of Ginger on the Gut Microbiome
Mankato, MN
The purpose of this study is to estimate the impact of a 6‐week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects..
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A Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Participants with Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated with Janus Kinase (JAK) Inhibitor
Rochester, MN
The purpose of this study is to evaluate the percentage of spleen (largest lymph organ in the body) response and symptom response of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to Janus Kinase (JAK) inhibitor treatment.
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Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Rochester, MN
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with ...
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Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-to-mesenchymal transitions. AXL was identified as a potential therapeutic target in chronic lymphocytic leukemia (CLL). TP 0903 was shown to induce apoptosis in CLL B-cells taken directly from patients.TP-0903 was equally potent against CLL cells regardless of risk-factor. TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with ...
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Safety and Immunogenicity of PolyPEPI1018 Vaccine in the Treatment of Metastatic Colorectal Cancer (OBERTO)
Rochester, MN
TREOS' Phase I clinical trial will investigate the safety, tolerability, and immunogenicity of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. This study will also explore the accuracy of prediction of pre-existing and newly induced CD8+ T cell responses in each patient using the PEPI Test and T lymphocyte infiltration detected in accessible biopsy sites.
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Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
Rochester, MN
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a single-agent comparator in countries that do not permit its use at this time.
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Breast Cancer Genome Guided Therapy Study (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this research study is to better understand the reasons why or why not breast cancers are destroyed by standard chemotherapy. This information will be used to develop new and better cancer therapies.
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Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells. PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in ...
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A Global, Randomized, Placebo-controlled Phase 3 Study of Fruquintinib in Patients with Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...
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A Study to Evaluate CC-96191 to Treat Participants With Relapsed or Refractory Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and effectiveness of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
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A Phase 2, Multicenter, Randomized Study of AP26113
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of two different dosing regimens of AP26113 in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with crizotinib.
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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (HIMALAYA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for advanced HCC. The patients cannot be eligible for locoregional therapy.
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A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Jacksonville, FL
The purpose of this study is to assess the safety, effectiveness, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).
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Safety of MT-401-OTS in Patients with Relapsed AML or MDS
Jacksonville, FL
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations.
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Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Jacksonville, FL
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia without a deletion 5q cytogenetic abnormality.
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Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
Rochester, MN
This phase II trial studies how well sapanisertib works in treating patients with acute lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Cancer Distress
Rochester, MN
The purpose of this study is to explore patient feedback regarding how physician behaviors influence their distress level.
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A Platform Study In Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
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Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
No Locations
This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
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A Study to Evaluate Whether Probiotics for Gut Microbiome Will Target Cancer Immune Microenvironment in Breast and Lung Cancer
Jacksonville, FL
The purpose of this study is to evaluate whether engineering gut microbiome using probiotics will alter host immunological response to breast and lung cancers.
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A Study of Intravital Microscopy (IVM) in Human Solid Tumors
Jacksonville, FL
The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
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A Study of ONC201 for Patients with H3 K27M-mutant and/or Midline High Grade Gliomas
Rochester, MN
The purpose of this project is to provide expanded access to ONC201 for patients with previously-treated H3 K27M-mutant and/or midline high grade gliomas who cannot access ONC201 through clinical trials.
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A Study to Evaluate the Safety and Effectiveness of Metformin and Nelfinavir with Bortezomib in Patients with Relapsed and/or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of administering metformin in combination with nelfinavir in patients with relapsed/refractory multiple myeloma.
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A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ
This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608 in combination with sorafenib, or BBI503 in combination with sorafenib. The study population is adult patients with advanced hepatocellular carcinoma who have not received systemic chemotherapy.
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A Study to Evaluate the Safety and Tolerability of DCC-2618 in Patients with Advanced Malignancies
Jacksonville, FL
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an expansion phase.
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A Study of CG-806 in Patients with Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
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The Young Women's Breast Cancer Study
Rochester, MN
The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment ...
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Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
Rochester, MN
The study is a multicenter, open label Phase I/II trial. 1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion) 2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225 alone (Phase 2 portion)
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A Study to Evaluate the Safety and Effectiveness of AB928-Based Treatment Combinations to Treat Patients with Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical activity, safety and tolerability of etruma-based treatment combinations.
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Cediranib Maleate and Selumetinib in Treating Patients With Solid Malignancies
Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib in treating patients with solid malignancies. Cediranib maleate and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the tumor.
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Rochester, MN
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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A Study of Vulvovaginal Symptoms in Premenopausal Stage 0-III Breast Cancer Patients Treated on Aromatase Inhibitors and Ovarian Suppression
Jacksonville, FL
The purpose of this study is to evaluate the change of vulvovaginal symptoms score from baseline to 6 months in premenopausal women with stage 0-III breast cancer treating with ovarian suppression in combination with aromatase inhibitors.
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CC-220-MM-001: A Phase 1b/2a Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
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Study of the Theranostic Pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to Identify and Treat Subjects with GPC3+ Unresectable HCC
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
A single arm, open-label Phase 1/1b study of the theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable HCC
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Dose-Escalation Study of cevostamab (BFCR4350A) in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Scottsdale/Phoenix, AZ
This is a phase I, multicenter, open-label, dose-escalation study of cevostamab (BFCR4350A) administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).
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Pancreatic Cancer Detection Consortium
Rochester, MN
The purpose of this study is to develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at high-risk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts. Additionally to follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes and to make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
Rochester, MN
AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients ...
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Extracorporeal Photopheresis And Mogamulizumab For The Treatment Of Erythrodermic Cutaneous T Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma.
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Study Using Chromogranin A As Surveillance Biomarker In Patients With CARcinoids
Rochester, MN
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
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Phase 3 Study Of Daraxonrasib (RMC-6236) In Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
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Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose ...
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A Study To Evaluate The Adverse Events, And Efficacy Of Intravenous (IV) Of Telisotuzumab Adizutecan In Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...
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Cholangiocarcinoma Liquid Biopsy Monitoring for Treatment Response and Prognostic Outcomes
Rochester, MN
The purpose of this study is to investigate the utility of using a PUMA (Proteins, mUtations, Methylated DNA, and Aneuploidy markers) platform to prognosticate and assess treatment response in patients with cholangiocarcinoma.
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A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
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Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a ...
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A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study consists of two parts to explore BGB-16673 recommended dosing: a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts).
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Phase 2 Study of VGT-309 in Lung Cancer
Rochester, MN
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
Scottsdale/Phoenix, AZ
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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Clinicopathological and Molecular Characteristics Associated With Acquired Resistance to Kinase Inhibitors in Thyroid Cancer
Rochester, MN
Objectives
The purpose of this study is to understand the clinicopathological and molecular characteristics associated with acquired resistance to kinase inhibitors in thyroid cancer.
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Ulixertinib in People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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Investigating Memory and Physical Activity after Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).
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Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer that has been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment ...
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A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A Study to Analyze the Association Between Financial and Health Insurance Literacy and Financial Distress in Patients Being Treated for Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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A Study to Assess the Effectiveness and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Study of MK-1026 in Patients with Selected Hematologic Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Testing Low Dose Tamoxifen For Invasive Breast Cancer, The (LoTam) Trial
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to ...
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Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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CJNJ-67652000 And Prednisone For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer And SPOP Gene Mutations
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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A Study Of Home-Based Therapy For Glioma
Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the feasibility of the remote chemotherapy management and patient monitoring platform GHoST Protocol among patients with glioma undergoing systemic therapy.
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NBTXR3 With or Without Cetuximab LA-HNSCC
Jacksonville, FL
The purpose of this study is to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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Safety Study of VAL-083 in Patients with Recurrent Malignant Glioma
Rochester, MN
The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
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A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Scottsdale/Phoenix, AZ
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.
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Phase 1/2 Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
Rochester, MN
Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD, and clinical activity evaluation of orally administered AG-221 in subjects with advanced hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical activity of AG-221 in select populations.
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Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Scottsdale/Phoenix, AZ
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
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Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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A Phase 1B Dose-escalation Study of TRC105 in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma
Jacksonville, FL; Rochester, MN
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with advanced soft tissue sarcoma.
The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft tissue sarcoma by RECIST 1.1.
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A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Rochester, MN
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
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Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155)
Rochester, MN
This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites. During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose ...
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A Trial of TTI-621 for Patients With Hematologic Malignancies and Selected Solid Tumors
Rochester, MN; Jacksonville, FL
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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A Study of Cemiplimab in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Scottsdale/Phoenix, AZ
The primary objective is to estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with Cemiplimab as a monotherapy.
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A Study of XmAb ®18087 in Subjects With NET and GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and tolerability profile of XmAb18087 in subjects with advanced, well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST), and to identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on Days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET and advanced GIST, separately.
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Rochester, MN; Jacksonville, FL
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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International Hepatobiliary Neoplasia Registry and Biorepository
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This study is being done to:
1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.
2. A second purpose of this study is to obtain blood and tissue samples from participants ...
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A Study to Evaluate the Effectiveness, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV).
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A Study Evaluating the Effectiveness of Oral Vismodegib in Various Histologic Subtypes of High Risk or Locally Advanced Basal Cell Carcinoma
Jacksonville, FL
The purpose of this study is to investigate the safety and effectiveness of oral vismodegib therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC). The term 'histologic subtype' refers to how the cells and tumor tissue looks under the microscope. Three different 'histologic subtypes' of basal cell skin cancer (infiltrative/morpheaform, nodular and superficial) will be examined in this study.
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SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Study to Evaluate the Safety, Tolerability and Preliminary Antitumor Activity of INCB059872 in Patients with Relapsed/Refractory Ewing Sarcoma
Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.
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Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Safety Study of SEA-TGT (SGN-TGT) in Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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A Study to Assess Financial Burden and Its Impact on Quality of Life in Patients with Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Study of AMG 650 in Adult Participants With Advanced Solid Tumors
Rochester, MN
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study to Evaluate Feasibility of In Vivo Sensitivity Screen Using Direct Tumor Microinjection and FDG-PET in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working.
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of Phase I of this study is to evaluate the safety and tolerability of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) / higher risk myelodysplastic syndromes (HR-MDS) / MDS/MPN to determine the recommended dose of CTX-712. The purpose of Phase II of this study is to assess the effiectiveness of CTX-712 in patients with R/R AML/HR-MDS by determination of complete remission (CR) rates.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.
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Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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Cardio-Oncology Clinic Registry
Rochester, MN
The purpose of this study is to establish a retrospective and prospective clinical registry of patients seen in the cardio-oncology clinic to characterize trends in the composition and outcomes of the population seen in the clinic, as well as initial clinical analyses on cardiovascular toxicities.
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ICCaRE Consortium Pilot Project 1: Feasibility Of A Point Of Prostate Cancer Diagnosis Intervention For Newly Diagnosed Black Men
Jacksonville, FL
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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Study of Ociperlimab in Combination With Tislelizumab in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objectives of this study are to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion.
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Once-daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
Jacksonville, FL
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide or abiraterone.
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Solid Tumor Monoclonal B-cell Lymphocytosis Screening
Rochester, MN
The purpose of this study is to determine whether monoclonal B-cell lymphocytosis (MBL) has an impact on clinical outcomes among patients with a diagnosis of a solid tumor.
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A Study to Determine Baseline Levels for Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
Rochester, MN
The purposes of this study are to determine the levels of prostate cancer-derived extracellular vesicles pre- and post-local therapy (radical prostatectomy or radiation therapy), to correlate analysis for PSA levels and prostate cancer-derived extracellular vesicles, and to determine baseline levels of prostate cancer-derived extracellular vesicles in patients undergoing different lines of primary local treatment.
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FT576 in Subjects With Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the recommended phase II dose for FT576 when administered as monotherapy and in combination with daratumumab, and to evaluate the safety and tolerability of FT576 when administered as monotherapy and in combination with daratumumab
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Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP Deletion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography for Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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A Study to Evaluate DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study
Rochester, MN
The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.
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A Study to Evaluate TAB006, as Monotherapy and in Combination with Toripalimab, in Patients with Previously Treated, Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of multiple doses of TAB006 as monotherapy and in combination with toripalimab to treat advanced malignancies.
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Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this trial is to identify the RP2D of STI-6129 by assessing the safety, preliminary effectiveness and pharmacokinetics in treating subjects with relapsed/refractory multiple myeloma (RRMM).
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A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke (EAISE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the effectiveness, safety, tolerability, and pharmacokinetics (PK) of elezanumab in subjects with acute ischemic stroke to potentially accelerate recovery and/or provide more complete recovery by decreasing neuronal damage and enhancing restoration of neuronal activity.
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Blood And Urine Identification Of Methylated DNA Markers In Invasive Bladder Carcinoma
Rochester, MN
The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. Diagnostic accuracy on urine can be compared with that on plasma using paired samples.
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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (ASCLEPIuS)
Rochester, MN
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (phase 2 portion of the study).
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Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Jacksonville, FL
The purpose of this study is to compare three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
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Circulating Tumor DNA (cTDNA) Based in NGS (Next Generation Sequencing) Assays for Oncology Patients With Solid Tumors
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of NGS assays using circulating tumor DNA for the detection of mutations associated solid tumors.
The performance characteristics of these assays for detecting ctDNA mutation in oncology patients will be assessed by comparing the mutation results obtained from these assays to those obtained by orthogonal methods, including tissue-based assays and results from a ctDNA assay by Guardant on blood.
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A Study Of PARG Inhibitor ETX-19477 In Patients With Advanced Solid Malignancies (ERADIC8)
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.
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A Study of PF-08052666/SGN-MesoC2 in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that ...
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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. Mayo Clinic will be pariticipating in Part B5, Sparse PK : ART0380 in combination with Irinotecan.
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Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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JAB-23E73 In Adult Participants With Advanced Solid Tumors With KRAS Alteration
Rochester, MN
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
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Screening and Staging of Benign vs Malignant Pelvic Abnormalities
Rochester, MN
The purpose of this study is to integrate GEHC’s AIR Recon DL (ARDL) technique to current protocols while reducing overall scan time.
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A Study To Assess BMS-986458 Alone And In Combination With Anti-lymphoma Agents In Relapsed/Refractory Non-Hodgkin Lymphomas
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader (LDD) of BCL6 (BCL6 LDD), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
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A Study To Assess Efficacy And Safety Of Pembrolizumab With Or Without Sacituzumab Tirumotecan (MK- 2870) In Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Jacksonville, FL; Rochester, MN
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
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Consent Forms In Cancer Research: Examining The Effect Of Length On Readability
Rochester, MN
The objectives of this study are to determine whether cancer patients report that shorter, or less wordy, consent forms are helpful to them as they decide about whether or not to enroll in a cancer clinical trial, and to determine whether shorter consent forms result in a greater percentage of patients’ enrolling in a cancer clinical trial, based on whether or not the patient has signed a mock consent form.
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A Study Of Single Patient Investigational Drug CPI-613 For Use In Treatment-Refractory, Metastatic Prostate Cancer
Rochester, MN
This is a single patient study of an investigational drug CPI-613 for treatment of metastatic prostate cancer.
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A Clinical Study Using MEDI-551 in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
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Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
Scottsdale/Phoenix, AZ
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced hematologic malignancies.
This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study ...
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Safety and Efficacy Study of MLN0128 in Combination With Exemestane or Fulvestrant in Postmenopausal Women With ER/PR+ Metastatic Breast Cancer
Rochester, MN; Rochester, MN
This is a phase 1b/2 study of the safety and efficacy of MLN0128 in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer that has progressed on treatment with everolimus in combination with exemestane or fulvestrant.
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Cancer of the Uterus and Treatment of Stress Urinary Incontinence
Rochester, MN
Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical health and decrease costs for both patients and the health care system. At the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo surgery within weeks of their diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and concurrent surgery performed. This would spare the patient two surgeries, decrease the emotional distress associated with SUI symptoms, decrease the costs associated with SUI for the patient and possibly improve overall quality of life. ...
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Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety ...
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Escalating Dose Study in Subjects with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
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Mayo Clinic Vestibular Schwannoma Quality of Life Index Assessment
Rochester, MN
The purpose of the study is to conduct cognitive testing of the recently published Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index.
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A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.
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IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome
Rochester, MN
The primary objective of this study is to determine the safety and tolerability of utilizing the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of advanced, previously treated myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML), including determining the maximum tolerated dose (MTD).
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Retrospective Study of Adult Acute Myeloid Leukemia and the Impact on Clinical Characteristics & Outcomes After Therapy
Jacksonville, FL
The purpose of this study is to perform a retrospective review of adult patients diagnosed with AML at all 3 Mayo Clinic sites over the past 25 years in order to identify prior exposures documented at presentation.
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Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
Rochester, MN
The purpose of this study is to determine safety and measure biodistribution of two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging.
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A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Scottsdale/Phoenix, AZ
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the ...
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A Study Of AL101 In Patients with Adenoid Cystic Carcinoma Bearing Activating Notch Mutations
Rochester, MN
The primary purpose of this study is to assess the clinical activity of AL101 using radiographic assessments and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Adenoid Cystic Carcinoma (ACC) patients with activating Notch mutations.
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A Study Comparing Gemcitabine with or without AZD 1775 in Treating Patients with Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
The purpose of this study is to compare gemcitabine hydrochloride in combination with AZD 1775 to gemcitabine hydrochloride given alone to treat patients with ovarian, primary peritoneal, or fallopian tube cancer that has returned after a period of time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA) molecules that contain instructions for the proper development and functioning of cells, which in turn stops the tumor from growing. AZD 1775 may block specific protein activity and may increase the effectiveness of gemcitabine hydrochloride by preventing the protein from repairing damaged tumor cells without causing harm to normal cells. It ...
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Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug, alisertib, is an investigational drug. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the lab that it may have an effect on a type of cell that produces platelets. This cell is called a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and MF.
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A Study to Assess Myocardial Blood Flow Changes in Oncology Patients
Rochester, MN
The primary purpose of this study is to determine if ICI administration causes microvascular damage/endothelial function.
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A Study of Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Jacksonville, FL; Rochester, MN
The NIR-DT-301 Phase 3, double-blind, placebo-controlled study is being conducted to determine the efficacy, safety, and tolerability of nirogacestat in participants with progressing desmoid tumors.
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Study of BLU-667 in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU-667 administered orally in patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.
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Immune Control of Breast Cancer Tumor Dormancy
Rochester, MN
The Primary Aim of this study is to quantify BDTC in breast cancer patients at different stages of cancer. As part of this aim we will establish the proliferation status of the tumor cells. We will in parallel examine CTC to determine the correlation between BDTC and CTC. The Second Aim is to determine role of tumor associated immune responses in maintaining tumor dormancy. Knowledge gained will provide the rationale for an in depth study of breast cancer tumor dormancy and immune response. Ultimately, the information gained will help us to design of immune intervention strategies that prevent cancer recurrence.
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Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the effectiveness of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
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Oxybutynin Chloride in Managing Hot Flashes
Rochester, MN
This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects.
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A Study to Evaluate the DermaSensor Tool on Skin Lesions Suggestive of Skin Cancer
Rochester, MN
The objective of this study is to investigate the sensitivity and specificity of the DermaSensor device in evaluating skin lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma, and to compare the sensitivity of DermaSensor to that of dermatopathology and primary care physicians' empiric diagnosis.
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Novel HSF1 Pathway Inhibitor NXP800 In Patients with Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose for NXP800.
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Surgical Drain Fluid for Detection of Molecular Residual Disease (MRD) in Bladder, Renal and Urothelial Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with bladder, renal or urothelial cancer.
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Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
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A Feasibility Study To Evaluate The Safety Of The TheraSphere Glioblastoma (GBM) Device In Patients With Recurrent GBM
Jacksonville, FL
The purpose of this study is to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent glioblastoma (GBM).
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MC1R-targeted Alpha-particle Monotherapy And Combination Therapy Trial With Nivolumab In Adults With Advanced Melanoma
Rochester, MN; Jacksonville, FL
In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma.
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Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).
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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
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A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.
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A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (SubQSA)
Jacksonville, FL; Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
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A Study Of CGM In GBM
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare standard glucose monitoring versus continuous glucose monitoring (CGM) with endocrinology-guided intervention in newly diagnosed glioblastoma (GBM) patients receiving standard-of-care therapy.
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A Study of the Safety and Effectiveness of HBI-8000 with Nivolumab to Treat Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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Novel Study Interventions and Combinations in Participants with Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with CRC.
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S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
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Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory).
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Pafolacianine for Localization of Pediatric Extracranial Solid Tumors
Rochester, MN
The purpose of this study is to determine the utility of NIR fluorescent imaging using the molecular imaging agent CYTALUX for identifying lesions in children and adolescent patients with primary or metastatic solid tumors.
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A Study To Assess The Safety And Tolerability Of CFT7455 In Relapsed/Refractory Non-Hodgkin's Lymphoma Or Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of CFT7455 administered orally in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) administered once a day (QD) as a single agent and in combination with dexamethasone.
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Melanoma Care Barriers In United States Latinx Population
Scottsdale/Phoenix, AZ
The purpose of this study is to provide qualitative analysis of barriers to melanoma care in the United States Latinx Population.
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SC Versus IV Isatuximab In Combination With Pomalidomide And Dexamethasone In RRMM
Jacksonville, FL
The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd.
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Study Of Bcl-2 Inhibitor BGB-11417 In Participants With Mature B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.
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A Study Of SGN-CEACAM5C In Adults With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The puprose of the study is to test the safety of SGN-CEACAM5C in participants with Advanced solid tumors.
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Long Term Outcomes in Pancreas Cancer Patients
Rochester, MN
The purpose of this study is to access long-term quality of life, complications, and implications of treatments on patients who are long-term survivors of pancreas cancer and were treated at Mayo Clinic.
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Robotic vs. Open NSM for Early Stage Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
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Engineering Gut Microbiome To Target Breast Cancer
Jacksonville, FL
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
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A Collaborative Intervention For Improving Cancer Pain Management In Rural And Hispanic Cancer Survivors (ASCENT)
Rochester, MN; Scottsdale/Phoenix, AZ
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially well matched for these patients, and can ...
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CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)
Rochester, MN
The purpose of this study is to determine the sensitivity and specificity of a blood test (DLCST) for the detection of lung cancer in a screening setting using the reference of Chest CT screening and a histologic diagnosis of lung cancer.
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A Study of the Bacteria Found in Cancerous and Non-cancerous Breast Tissue
Rochester, MN
The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.
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Black Prostate Cancer Survivors
Jacksonville, FL
The purpose of this study is to investigate the experiences and challenges faced by Black men in their journey of surviving prostate cancer. By exploring various aspects of survivorship, including physical, emotional, and social dimensions, this research aims to provide valuable insights into the unique needs of this population and inform the development of targeted support interventions.
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A Registry For People With Lung Cancer
Rochester, MN
The purpose of this study is to determine 3- and 5-year disease-free survival (DFS) among patients undergoing pulmonary segmentectomy for lung cancer. Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
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SRG-514 Administered Intraoperatively To Patients Undergoing Breast-conserving Cancer Surgery
Rochester, MN
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
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Group Curriculum for Improving Survivorship Outcomes in Adolescent and Young Adult Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to develop the curriculum and assess its feasibility and impact on equipping young adults to better manage these aspects of survivorship: follow up medical care, work/school life, relationships and coping with the emotional impact of cancer survivorship.
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CAncer Survivor CArdiomyopathy DEtection (CASCADE) Pilot Study
Rochester, MN
The purpose of this study is to improve the cardiovascular care of adult cancer survivors by contributing much-needed evidence regarding optimal surveillance and treatment recommendations. This application’s objective is to obtain the data necessary to plan an adequately powered randomized clinical trial (RCT) across a nation-wide network that will define prospectively the clinical and economic efficacy of a screening program that uses AI-ECG and/or NT-pro-BNP in an at-risk adult cancer survivor population.
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A Study Using Bioimpedance Spectroscopy versus Tape Measurement in Catching and Intervening in the Early Onset of Lymphedema
Jacksonville, FL
The purpose of this study is to compare the use of Bioimpedance Spectroscopy versus tape measurements for follow-up arm measurements after regional treatment for breast cancer. Catching the smallest increases in fluid buildup and intervening early may result in a decrease in the rate of progressions to chronic lymphedema.
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Broad Evidence of Systemic Immune Activation in Long Term Survivors of Advanced Ovarian Cancer
Rochester, MN
The purpose of this study is to determine if long-term ovarian cancer survivors after receipt of a vaccine targeting folate receptor alpha will have persistent T cell and antibody responses to folate receptor alpha and will have broad evidence of systemic immune activation.
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A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery
Jacksonville, FL
The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
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Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study
Rochester, MN
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an ...
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Prostate Imaging Using MRI +/- Contrast Enhancement
Rochester, MN
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.
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A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Jacksonville, FL
The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib combination therapies of Part 2.
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A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of trhis study is to evaluate CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm).
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Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-based Classifier in Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to prospectively validate a new Artificial Intelligence (AI)-based model developed by our team to analyze TVUS images for early EC detection.
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Group Meaning-Centered Psychotherapy For The Improvement Of Wellbeing In Caregivers Of Patients With Advanced Cancer
Rochester, MN; Jacksonville, FL
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual ...
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A Study of Patients Undergoing Neoadjuvant Therapy for Resectable Non-small Cell Lung Cancer to Evaluate Perioperative Circulating Tumor DNA as a Prognostic Biomarker
Jacksonville, FL
The purpose of this study is to determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
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Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma
Rochester, MN
This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma (RRMM)).
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Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma
Rochester, MN
Laboratory studies suggest that the study drug may stop cancer cells from growing by affecting an interaction between proteins in the cells referred to as cAMP-response element-binding protein and ß-catenin.
The purpose of this research study is to determine the highest safe dose of study drug that may be used when it is given together with a chemotherapy drug to patients with cancer of the pancreas.
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A Study to Evaluate Pevonedistat, Azacitidine (or Decitabine), and Venetoclax (PAVE) to Treat Acute Myelogenous Leukemia (AML) Patients
Rochester, MN
The purpose of this study is to determine a recommended phase 2 dose (RP2D) of pevonedistat, azacitidine (or decitabine), and venetoclax to treat Acute Myelogenous Leukemia.
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Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.
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A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to measure how patient anxiety changes using a validated patient reported outcome measure, to measure radiotherapy completion rates in the American Indian/Alaska Native (AI/AN) community, and to measure patient perception of information received using a validated patient reported outcome measure.
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A Study to Compare Conventional Heart Echo Measurements with Newer 2 and 3 Dimensional Measurements of Mechanical Heart Strain after Trastuzumab Infusion
Rochester, MN
The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.
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Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Rochester, MN; Jacksonville, FL
This randomized pilot clinical trial studies topical cryotherapy (a procedure in which an extremely cold liquid is used to freeze and destroy abnormal tissue) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy may help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.
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A Study of Unesbulin Combined with Dacarbazine to Treat Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The primary purpose of this study is to determine the maximum tolerated dose (MTD) and overall safety profile of PTC596 in combination with dacarbazine for the treatment of advanced Locally Recurrent, Unresectable or Metastatic Relapsed/Refractory Leiomyosarcoma (LMS).
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A Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis
Jacksonville, FL
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
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MDM2 Inhibitor AMG-232 and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Subjects With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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Carboplatin and Gemcitabine Hydrochloride With or Without VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II trial studies the side effects and how well carboplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking ...
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A Study to Evaluate Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma
Rochester, MN
The purpose of this study is to compare the effectiveness of Carboplatin-Paclitaxel with INCMGA00012 vs. Carboplatin-Paclitaxel with placebo in participants with inoperable, locally-advanced or metastatic Squamous Cell Anal Carcinoma (SCAC) not previously treated with systemic chemotherapy.
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Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer
Albert Lea, MN
The purpose of this study is to determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation therapy (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
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Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) at 3 months post-radiotherapy for prostate cancer.
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Clinical Trial of the ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Recurrent Brain Tumors
Rochester, MN
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Rochester, MN
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with ...
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Genetic Testing in Screening Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Rochester, MN; Scottsdale/Phoenix, AZ
This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
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hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
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Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This phase II trial studies how well olaparib and cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin ...
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Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in ...
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Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in ...
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Comparison of Mitoxantrone-Based Salvage Therapies (MEC vs CLAG-M) in Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ
The purpose of this study is to determine potential differences between the 2 therapeutic regimens.
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Evaluating Patient Reported Outcomes in Radiation Therapy, The PRO-RT Study
Rochester, MN
The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo device enabled patient specific data aggregation, will increase the completeness and accuracy of the Outcomes Registry and improve patient engagement with the care teams, post radiation, by acquiring linked outside EHR information facilitating improved collection of patient reported outcome surveys, and biometric data via a wearable device.
With a rise in health care costs, there is an urgent need to evaluate patient outcomes and the value of care levering real patient, big data from the ...
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A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...
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A Phase 1b/2 Study of Onvansertib (PCM-075) in
Combination with FOLFIRI and Bevacizumab for
Second-Line Treatment of Metastatic Colorectal Cancer
in Patients with a KRAS Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
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A Study to Analyze Supine Breast MRI
Rochester, MN
The purpose of this study is to characterize the changes occurring in breast tumor-associated properties/ dimensions between the prone and supine imaging positions and to develop a dataset of supine-positioned MRIs that can be translated into an operative setting for real-time visualization.
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to test an experimental combination of two drugs, ABT-888 and Cyclophosphamide (CP), which we hope may eventually lead to promising new therapies for cancer.
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Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
Rochester, MN
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to compare the effectiveness and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy.
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A Study to Evaluate Trifluridine/Tipiracil in Combination with Irinotecan to Treat Biliary Tract Cancers
Rochester, MN
The purpose of this study is assess the effectiveness of trifluridine/tipiracil plus irinotecan in treating advanced, refractory biliary tract cancers (BTCs).
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3D Surface Scanning
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the potential for using a 3D scan of a patient’s treatment surface as a surrogate for a conventional CT simulation in electron radiation therapy.
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A Study to Evaluate Ribociclib Plus Letrozole to Treat Cancer of the Ovary, Fallopian Tube or Peritoneum
Rochester, MN
The purpose of this study is to evaluate the response to treatment with Ribociclib and Letrozole in patients with low-grade serous cancer of the ovary, fallopian tube or peritoneum.
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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
Rochester, MN
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
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A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with cetrelimab and cetrelimab alone.
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Accelerated vs Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Rochester, MN
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
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A Study to Evaluate Ramucirumab Plus Trifluridine/Tipiracil to Treat Patients with Previously-treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/Gastroesophageal Junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with TAS-102 vs. paclitaxel and ramucirumab.
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Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
Rochester, MN
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
Rochester, MN
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib ...
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Collection of Specimens and Clinical Data for Patients with Recurrent or Metastatic Breast Cancer or Male Breast Cancer
Rochester, MN
The purpose of this study is to collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer. The biospecimens will be used for analysis of genetic alterations in germline and tumor DNA and for tracking of response to therapy using blood-based liquid biopsy approaches.
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Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors ...
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Radiation Treatment Planning Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to integrate a novel head and neck segmentation algorithm into the current clinical standard operating procedure for radiation treatment planning within the Mayo Clinic Department of Radiation Oncology Practice.
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Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)
Rochester, MN
The purpose of this study is to test the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel.
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Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Rochester, MN
The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.
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Group Curriculum for Improving Survivorship Outcomes in Adolescent and Young Adult Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to develop the curriculum and assess its feasibility and impact on equipping young adults to better manage these aspects of survivorship: follow up medical care, work/school life, relationships and coping with the emotional impact of cancer survivorship.
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Broad Evidence of Systemic Immune Activation in Long Term Survivors of Advanced Ovarian Cancer
Rochester, MN
The purpose of this study is to determine if long-term ovarian cancer survivors after receipt of a vaccine targeting folate receptor alpha will have persistent T cell and antibody responses to folate receptor alpha and will have broad evidence of systemic immune activation.
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A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery
Jacksonville, FL
The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
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A Study to Compare Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
Rochester, MN
The purpose of this study is to compare a mobile health and social media physical activity intervention versus wearing a physical activity tracker among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels ...
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A Study to Compare Docetaxel/Prednisone to Docetaxel/Prednisone Combined with OGX-011 in Men with Prostate Cancer
Rochester, MN
The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone.
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Evaluating Bladder CARE™, A New Non-Invasive Urine Test, For Bladder Cancer Detection In Inconclusive Cases
Rochester, MN
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:
• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?
Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), ...
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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, And Elotuzumab, Pomalidomide, And Dexamethasone Or Pomalidomide, Bortezomib, And Dexamethasone In Participants With Relapsed Or Refractory Myeloma Who Have Received An Anti-CD38 Antibody And Lenalidomide
Rochester, MN
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
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Azacitidine and Sonidegib in Treating Patients With Myeloid Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/IB trial studies the side effects, best dose, and efficacy of azacitidine and erismodegib in treating patients with myeloid malignancies. The hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo. Erismodegib binds to the Hh cell surface receptor Smo, which may result in the suppression of the Hh signaling pathway and the inhibition of cancer cells. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed ...
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Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Rochester, MN
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
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A Study to Evaluate Nasal Vestibulitis Symptoms in Patients Undergoing Systemic Antineoplastic Therapy
Rochester, MN; Mankato, MN; Albert Lea, MN; Austin, MN
The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy.
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Three-Dimensional Ultrasound in the Determination of Tumor Volume and Myometrial Invasion in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.
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A Study to Evaluate AVB-S6-500 with Paclitaxel vs Paclitaxel in Patients with Platinum-resistant Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate AVB-S6-500 in combination with paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer to compare the effectiveness and of AVB-S6-500 in combination with Pac versus placebo plus Pac.
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A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this phase 3, randomized, double-blind, multicenter study is to compare Oral Ixazomib (MLN9708) plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.
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Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well lenalidomide and dexamethasone work in treating patients with relapsed or refractory multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells.
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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy In Previously Treated Advanced Or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations Or Other Genomic Alterations (MK-2870-004)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations.
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Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Rochester, MN
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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S1406 A Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...
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Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Scottsdale/Phoenix, AZ
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
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Phase 2 Nab®-Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects with Locally Advanced Pancreatic Cancer (LAPC)
Scottsdale/Phoenix, AZ
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
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A Study of Cediranib and Olaparib Combined, Compared to Either Drug Alone, or to a Standard Chemotherapy in Treating Patients who have a Return of Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN
The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Rochester, MN
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
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A Study to Evaluate Nasal Vestibulitis Symptoms in Patients Undergoing Systemic Antineoplastic Therapy
Rochester, MN; Mankato, MN; Albert Lea, MN; Austin, MN
The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy.
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Three-Dimensional Ultrasound in the Determination of Tumor Volume and Myometrial Invasion in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.
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Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well lenalidomide and dexamethasone work in treating patients with relapsed or refractory multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells.
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Study of ASTX727 vs IV Decitabine in MDS and CMML
Rochester, MN
Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.
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Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal ...
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Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Rochester, MN
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.
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A Study to Evaluate Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
Eau Claire, WI; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN; La Crosse, WI
The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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A Study of Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)
La Crosse, WI
The purpose of this study is to evaluate the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.
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A Study to Evaluate AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment
Rochester, MN
The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone.
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The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Albert Lea, MN; Mankato, MN
The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.
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A Study of Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients with Previously Treated Multiple Myeloma or Plasma Cell Leukemia
Rochester, MN
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
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A Study of Catequentinib, Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of AL3818 (catequentibub, anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
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A Long Term Follow Up of Mammography Screening
Rochester, MN
The purpose of this study is to execute a long-term retrospective observational cohort study of women who underwent screening mammography (defined as digital mammography or tomosynthesis).
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Colorectal Cancer Screening/Microbiome Collection
Jacksonville, FL
The purpose of this study is to evaluate the integration of cancer genetic testing into a cancer clinical practice aimed towards patients of various ethnic populations in Arizona and Florida – including, but not limited to, Hispanic/Latino, Native American/Alaskan, African American, and Asian by self-report.
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A Study to Evaluate EAA181 to Treat Newly-diagnosed Multiple Myeloma
Rochester, MN; La Crosse, WI
The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
Rochester, MN
The purpose of this study is to compare hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable).
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Reduced Dose Hypofractionated Radiotherapy For Indolent Non-hodgkin Lymphoma
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of thisstudy is to evaluate reduction of radiotherapy dose for patients with indolent NHL by conducting a prospective randomized phase 2 study comparing reduced dose hypofractionated ISRT of 9 Gy delivered over 3 fractions (BED 12 Gy) to standard of care 24 Gy delivered over 12 fractions (BED 29Gy), while simultaneously evaluating prognostic value of pre-radiation functional imaging parameters and molecular markers to predict treatment response and failure.
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Study Of Quemliclustat And Chemotherapy Versus Placebo And Chemotherapy In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
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A Study to Assess the Effectiveness of Osimertinib Plus Savolitinib in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) Following Prior Osimertinib
Rochester, MN
The purpose of this study (the SAVANNAH study) is tol investigate the effectiveness of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following treatment with osimertinib.
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Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Rochester, MN
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
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Broad Evidence of Systemic Immune Activation in Long Term Survivors of Advanced Ovarian Cancer
Rochester, MN
The purpose of this study is to determine if long-term ovarian cancer survivors after receipt of a vaccine targeting folate receptor alpha will have persistent T cell and antibody responses to folate receptor alpha and will have broad evidence of systemic immune activation.
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A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery
Jacksonville, FL
The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
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Prostate Cancer Cell Lines Using Biopsies of Early Stage Prostate Cancer Patients and Research on Cancer Mechanisms Through Its Genes and Proteins
Rochester, MN
The purpose of this study aims to establish a total of 30 new primary prostate cancer cell lines using a portion of biopsy tissue from early-stage prostate cancer patients and to collect protein characterization data showing high expression for each cell line. The primary objective is to discover specific genes and proteins that show excessive expression differences in each group of prostate cancer cell lines. The specific genes and proteins obtained here will be used to find customized anticancer candidates for prostate cancer patients in the future. As a final objective, we aim to build a new classification of existing ...
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A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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A Study to Evaluate Gemcitabine in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
Rochester, MN; Jacksonville, FL
The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).
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Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).
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A Study to Evaluate Docetaxel With or Without Bintrafusp Alfa to Treat Patients with Advanced Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and Combined with Chemotherapy or Tislelizumab to Treat Patients with Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish the safety and tolerability, and to determine the recommended Phase 2 dose (RP2D) for LYT-200.
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A Study to Evaluate Effectiveness and Safety of MBG453 in Combination with Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of MBG453, or placebo added to azacitidine, in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.
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A Study Comparing X-396 (Ensartinib) to Crizotinib in Patients with ALK Positive Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness and safety of X-396 (ensartinib) versus crizotinib in patients who have ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
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A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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A Study to Evaluate Genetic Testing in Guiding Treatment for Patients with Brain Metastases
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evauate how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.
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Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy
Rochester, MN
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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Vinorelbine Tartrate and Cyclophosphamide in Combination with Bevacizumab or Temsirolimus in Treating Patients with Recurrent or Refractory Rhabdomyosarcoma
No Locations
This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide work in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop ...
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Dinaciclib, Bortezomib, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when given together with dexamethasone in treating patients with relapsed multiple myeloma. Dinaciclib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer cells.
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Etiology, Prevention And Therapy Navigation Of Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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A Trial of TTI-621 in Combination With Doxorubicin in Patients With Leiomyosarcoma
Jacksonville, FL
The purpose of this study to evaluate TTI-621 combined with Doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma.
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Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma
Rochester, MN
This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with ...
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A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Rochester, MN
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Rochester, MN
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and ...
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers
Rochester, MN; Jacksonville, FL
This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential ...
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A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.
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A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma and FGFR2 gene fusions or FGFR2 gene mutations or amplifications
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of ARQ 087 capsules.
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A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
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A Study in Subjects with Malignant Pleural Mesothelioma to Assess ADI-PEG 20 with Pemetrexed and Cisplatin
Rochester, MN
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
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An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the effect of ixazomib+dexamethasone (ixa+dex) versus pomalidomide+dexamethasone (pom+dex) on progression-free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to lenalidomide but not refractory to proteasome inhibitors.
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Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)
Rochester, MN
The purpose of this study is to test the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel.
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Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
Rochester, MN
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
Rochester, MN
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib ...
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Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Rochester, MN
The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.
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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
Rochester, MN
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
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A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with cetrelimab and cetrelimab alone.
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Accelerated vs Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Rochester, MN
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
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Pilot Study of Care at Home for Monitoring Brain Tumor Patients
Rochester, MN
The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.
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A Study to Evaluate A Resilient Living Program for Patients with Advancer Cancer and Their Caregivers
Rochester, MN
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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Study Of SX-682 Alone And In Combination With Oral Or Intravenous Decitabine In Subjects With Myelodysplastic Syndrome
Jacksonville, FL
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Learning From Patients How They Were Educated On Chemotherapy Side Effects
Rochester, MN
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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Combination Chemotherapy in Treating Patients with Non-Metastatic Extracranial Ewing Sarcoma
Rochester, MN
This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
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Ruxolitinib Phosphate (Oral JAK Inhibitor INCB18424) in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well giving ruxolitinib phosphate (oral JAK inhibitor INCB18424) works in treating patients with relapsed or refractory diffuse large B-cell or peripheral T-cell non-hodgkin lymphoma and are ineligible to stem cell transplant or have recurrent disease after stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Lenalidomide and AT-101 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Jacksonville, FL
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
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A Study to Assess AC220 Given in Combination with Induction and Consolidation Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML)
Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
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Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of nal-IRI in combination with 5-FU/LV and oxaliplatin in patients not previously treated for metastatic pancreatic adenocarcinoma to select a regimen for further development.
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Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer
Rochester, MN
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
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Study of Magrolimab Combination Therapy to Treat Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment
The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination ...
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Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
Rochester, MN
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some ...
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Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of these phase I/II trial studies is to analyze the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium, and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body. Drugs used in chemotherapy, such as liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study of Adding AMG 479 to First Line Chemotherapy in Patients with Optimally Debulked Epithelial Ovarian Cancer
Rochester, MN
The purpose of this study is to determine the value of adding AMG 479 (a fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin (first line chemotherapy) for the treatment of patients who have ovarian epithelial cancer that has been surgically removed to less than 1 cm thick.
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A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Jacksonville, FL
Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
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A Study Comparing Temozolomide and Selumetinib for Treating Patients with Metastatic Melanoma of the Eye
Rochester, MN
The purpose of this study is to compare the effectiveness of temozolomide to selumetinib for the treatment of patients who have melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.
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A Phase 1 Dose Escalation and Expansion Study of TGR-1202 + Ruxolitinib in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, or Polycythemia Vera Resistant to Hydroxyurea
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
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Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Rochester, MN
This randomized phase II trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective ...
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Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
Rochester, MN
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
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Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.
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A Study to Assess the Safety and Tolerability of ADI-PEG 20 Combined with Pemetrexed and Cisplatinin in Subjects with Tumors Requiring Arginine
Rochester, MN
The purpose of this study is to assess the safety and tolerability of ADI-PEG 20 combined with pemetrexed and cisplatin in patients with tumors requiring arginine such as advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non squamous non-small cell lung cancer (stage IIIB/IV), metastatic uveal melanoma, advanced liver cell cancer or recurrent high-grade glioma.
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Study of Cisplatin-Induced Peripheral Neuropathy in Patients with Germ Cell Tumor
Rochester, MN
The purpose of this study is to investigate the incidence, characteristics of, and changes in chronic neuropathy symptoms related to cisplatin and evaluate the natural history of platinum induced peripheral neuropathy during active treatment and the first 12 months post chemotherapy.
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Cisplatin and Gemcitabine Hydrochloride With or Without ATR Kinase Inhibitor VX-970 in Treating Patients With Metastatic Urothelial Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer that has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin ...
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A Study to Evaluate The Effect of Diet and Exercise on Biomarkers Associated with Obesity and Breast Cancer in Overweight Women with Early Stage Breast Cancer
Rochester, MN
The primary purpose of this study is to investigate the relationship between a technology-assisted diet and exercise program which is easily implemented in an outpatient setting and the levels of biomarkers that have been associated with breast cancer recurrence risk in overweight women with stage 0, I, or II breast cancer.
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Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
Rochester, MN
The purpose of this study is to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma.
Additionally, to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes ...
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MC1733, Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter pylori Neutrophil-activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer
Rochester, MN
To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer.
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A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma
Rochester, MN
This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).
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A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
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A Study of Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That Is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well trametinib works in treating patients with epithelioid hemangioendothelioma that has spread to other places in the body, nearby tissue or lymph nodes, or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Evaluate APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
Jacksonville, FL; Rochester, MN
This study is designed to investigate whether a new experimental treatment known as APR 246 will be an effective and safe treatment option for patients with MDS.
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A Study Comparing Combination Chemotherapy to Gemcitabine Hydrochloride and Nab-Paclitaxel Given Before Surgery for Treating Patients who have Pancreatic Cancer that can be Removed by Surgery
Rochester, MN
The purpose of this study is to assess the best 2-year overall survival when comparing fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) to gemcitabine hydrochloride and nab-paclitaxel, given before surgery for treating patients who have pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy ...
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A Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer (CASCARA)
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine the proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria 1 year, with 6 cycles of carboplatin and cabazitazel followed by continued abiraterone.
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Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
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Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
Rochester, MN
This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Scottsdale/Phoenix, AZ
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
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A Study to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.
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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
Scottsdale/Phoenix, AZ; Rochester, MN
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used ...
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A Study To Compare Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Rochester, MN
The purpose of this study is to to determine the individual treatment effect of somatostatin and whether duration of antibiotic therapy coupled with octreotide provides improved outcomes after pancreaticoduodenectomy.
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MEDI5752 In Combination With Carboplatin Plus Pemetrexed In Unresectable Pleural Mesothelioma
Jacksonville, FL; Rochester, MN
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
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Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.
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A Study to Evaluate Treatment of Established Chemotherapy-induced Neuropathy with Fingolimod
Rochester, MN
The purpose of this study is to determine if the use of Fingolimod can reduce neuropathy caused by chemotherapy.
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Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Rochester, MN
The purpose of this study is to evaluate nurse-based care coordination compared to usual care on 30-day risk-adjusted readmission rates among high risk patients.
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A Study of the Safety and Effectiveness of Using Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Jacksonville, FL
The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure during induction chemotherapy for patients with acute myeloid leukemia (AML).
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A Study to Evaluate 9-ING-41 As a Single Agent or in Combination with Ruxolitinib in Myelofibrosis Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness of 9-ING-41, either by itself or in combination with Ruxolitinib, in patients with advanced myelofibrosis. 9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has both pre-clinical anti-fibrotic activity and activity against myelofibrosis. 9-ING-41 may reduce the dose of Ruxolitinib needed for optimal therapeutic response and/or reverse myelosuppression so than an adequate dose of Ruxolitinib can be tolerated for an adequate duration to confer an optimal therapeutic outcome.
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Combination Chemotherapy in Treating Younger Patients with Newly Diagnosed, Non-Metastatic Desmoplastic Medulloblastoma
Rochester, MN
This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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A Study of Performing Surgery for Resectable Malignant Pleural Mesothelioma After Radiation Therapy
Rochester, MN
The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.
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A Study Using Clofarabine and Cytarabine in Treating Children with Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
No Locations
Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
The purpose of this trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
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Short-course Radiation Therapy for Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).
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A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.
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A Study of Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer
La Crosse, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaouate how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.
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Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.
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A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
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Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will ...
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DNA Damage Using HERY-MNT Technology Can Predict Chemotherapy Induced Toxicity In Women With Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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Long-Term Follow-Up Of Patients Who Have Participated In Children's Oncology Group Studies
Rochester, MN
This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.
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A Study of Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia
Rochester, MN
The purpose of this study is to assess the effectiveness and long term side effects of using combined tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by ...
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A Study To Investigate The Safety And Tolerability Of Ziftomenib In Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, Or 7+3+Quizartinib In Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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Lenalidomide or Observation in Treating Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
Rochester, MN
This phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.
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Analyses Of Metabolic Agents Following Brain Radiation
Rochester, MN
The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.
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Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Empty Bladder Impact During Radiation Therapy for Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether an empty bladder during radiation therapy delivery for prostate cancer affects patient-reported urinary symptoms related to treatment.
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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Jacksonville, FL
The purpose of this study is to test whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts.
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Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them ...
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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A Study To Compare Standard Chemotherapy To Therapy With CPX-351 And/or Gilteritinib To To Treat Newly-diagnosed AML With Or Without FLT3 Mutations
Rochester, MN
The purpose of this study is to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
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Telehealth Assessments With Glioma Receiving Oral Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the safety, feasibility and acceptability of telehealth assessments for patients with GBM receiving oral chemotherapy.
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A Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Rochester, MN
The purpose of this extension study is for subjects who participated in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01, ASTX727-02, ASTX727-04).
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A Study of Niraparib Combined with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone to Treat Metastatic Prostate Cancer
Scottsdale/Phoenix, AZ
The objectives of this study are to determine if Niraparib, Abiraterone Acetate (AA), and Prednisone compared with AA and Prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated mCSPC provides superior effectiveness in improving radiographic progression-free survival (rPFS), to assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC, to characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of ...
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A Multicenter Study In Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence For Rapid Lung Cancer Detection - The ON-SITE Study
Jacksonville, FL
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
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A Study Of The Use Of Cold Caps To Prevent Hair Loss In Chemotherapy Patients
Rochester, MN
The purpose of this study is to learn, in patients’ own words, what cancer patients who are using a cold cap to prevent hair loss are experiencing.
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Effects of a Hospitality Initiative on Referral Patterns for Native American Cancer Patients in Maricopa County
Scottsdale/Phoenix, AZ
The purpose of this study is to interview patients and providers at Phoenix Indian Medical Center and Mayo Clinic Arizona to identify perceptions, experiences, and perceived factors influencing referrals and enrollment on clinical trials in the Department of Radiation Oncology at Mayo Clinic Arizona.
The overall goal of this line of research is to enhance the hospitality, cultural responsiveness, and efficiency with which a leading cancer center can collaborate with a neighboring treatment hub for an important, underserved population within that cancer center’s catchment area.
American Indian and Alaska Native people experience higher rates of cancer ...
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A Study to Find the Recommended Dose for Further Research for VX-970 and Whole Brain Radiation Therapy to Treat Patients with Brain Metastases from Non-Small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the side effects and best dose of ATR kinase inhibitor VX-970 when given together with whole brain radiation therapy for the treatment of patients who have non-small cell lung cancer that has spread from the original (primary) tumor to the brain. VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving VX-970 together with radiation therapy may be a better treatment for non-small cell lung cancer.
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Ventricular Remodeling and Myocardial Deformation in Patients Undergoing Chemotherapy for Sarcomas
Rochester, MN
The aim of this study is to determine if there is subclinical systolic or diastolic myocardial mechanical dysfunction by 2D and 3D speckle tracking echocardiography derived strain and strain rate in this patient population at baseline, during and after chemotherapy. This could be an early marker of myocardial dysfunction in patients treated for sarcoma.
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A Study to Assess the Safety and Preliminary Effectiveness of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this study is to evaluate the safety and preliminary effectiveness of the human anti-CD19 antibody Tafasitamab, in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
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Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is: negative for RAS wild-type colorectal cancer and has spread to other places in the body, and/or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the ...
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A Study to Compare Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
Rochester, MN
This study aims to evaluate the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.
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Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk Myelodysplastic Syndromes
Jacksonville, FL; Rochester, MN
The purpose of this study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 Myelodysplastic Syndromes (MDS). This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.
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Breast MR
Rochester, MN
The purpose of this study is to examine the capability of contrast enhanced breast PCD-CT in staging breast cancer within the breasts and regional nodes of human subjects. Developing and using a PCD-CT imaging technique and postprocessing algorithms, dedicated for breast cancer detection.
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A Study of Gemcitabine-Cisplatin Chemotherapy plus Necitumumab in the First-Line Treatment of Patients with Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and effectiveness of combined gemcitabine and cisplatin chemotherapy plus necitumumab for the treatment of patients who have late stage lung cancer.
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A Study for Women who have Platinum Resistant Ovarian Cancer to Evaluate EC145 Combined with Pegylated Liposomal Doxorubicin, Compared to Pegylated Liposomal Doxorubicin Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival in women who have platinum-resistant ovarian cancer, who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with those who receive PLD alone.
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A Study of BBI608 Combined with Standard Chemotherapies in Adult Patients who have Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and best study dose of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or with MM-398, 5-FU and leucovorin in patients who have pancreatic adenocarcinoma that has spread.
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CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
Jacksonville, FL
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
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A Study of Lenalidomide Combined with a Standard Chemotherapy for Treating Patients with Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to assess the safety, effectiveness and strongest tolerated dose of lenalidomide when given together with a standard chemotherapy to treat patients who have newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with ...
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A Study of the Safety and Effectiveness of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects with Unremoveable Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of amatuximab in combination with pemetrexed and cisplatin in subjects with unremovable malignant pleural mesothelioma, who have not received prior systemic therapy.
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Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
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Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
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Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Scottsdale/Phoenix, AZ
Phase I Dose Escalation: To investigate the MTD, safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in patients ≥ 65 years of age with newly diagnosed previously untreated AML, relapsed or refractory AML or high risk MDS, and considered ineligible for standard intensive therapy. Phase I MTD Extension: To collect additional data on safety, efficacy and pharmacokinetics and to confirm the Recommended Phase II Dose (RP2D), of volasertib in combination with decitabine in previously untreated patients with AML ≥ 65 years of age and considered ineligible for standard intensive therapy. Phase IIa: Efficacy of volasertib in combination with ...
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A Study of Parsaclisib in Combination With Ruxolitinib to Treat Subjects with Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
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A Study to Evaluate the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
Rochester, MN
The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.
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Testing the Addition of Ixazomib to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial
Rochester, MN
This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.
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Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Jacksonville, FL; Rochester, MN
This pilot, phase II trial studies how well everolimus and letrozole work in treating patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by blocking some the enzymes needed for cell growth.
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Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
Rochester, MN
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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A Study Comparing a Vaccine with or without an Autologous Tumor Lysate to Treat Stage III or IV Melanoma to Prevent Recurrence
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare a vaccine with autologous tumor lysate loaded into yeast cell wall particles that are naturally and efficiently taken up into a patient's dendrite cells to a placebo without the autologous tumor lysate. The vaccine is formulated to treat stage III or IV resected melanoma to prevent recurrence.
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Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
Rochester, MN
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.
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A Study to Evaluate Pevonedistat and Venetoclax Plus Azacitidine in Adults with Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy
Jacksonville, FL
The purpose of this study is to determine whether the combination of pevonedistat + venetoclax + azacitidine improves event-free survival (EFS) compared with venetoclax + azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy.
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PF-07284892 in Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
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PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
Jacksonville, FL
Primary Objectives
1. To determine the safety and tolerability profile of weekly IV dosing of XmAb14045
2. To identify the first dose MTD/RD
3. At first dose MTD/RD, to then identify the second (and subsequent) infusion MTD/RD
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Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate if the combination of trivalent adenovirus-5 (Tri-Ad5) vaccines and IL-15 superagonist N-803 reduces the incidence of colorectal neoplasms in patients with Lynch syndrome (LS).
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Actinium Therapy For Late-stage Aggressive Sarcomas
Rochester, MN
The goal of this clinical trial is to learn about the safety of drug \[Ac225\]RTX-2358 and the diagnostic imaging agent \[Cu64\]LNTH-1363S. Additionally Ratio Therapeutics will learn if \[Ac225\]RTX-2358 drug is effective in treating advanced sarcoma.
The main questions the study aims to answer in Phase/Part 1 of the trial are:
* Is \[Ac225\]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients.
* What is the most tolerable dose of \[Ac225\]RTX-2358
* Does the treatment show effectiveness on advanced sarcoma
Participants will:
* Take drug \[Ac225\]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months
* Visit the clinic ...
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A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor
Rochester, MN
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.
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Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purose of this study is to evaluate the effiectiveness, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory Primary Central Nervous System Lymphoma PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolimide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B). Mayo Clinic is only participatin gin Part B, and only in the MTR regimen.
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Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to assess the safety and preliminary efficacy of segmental ablative radioembolization in combination with Tremelimumab plus Durvalumab (MEDI4736) in patients with cholangiocarcinoma who are not candidates for curative therapy. transplantation will be enrolled in two cohorts.
The primary objective of the study is to characterize the safety of the combination of Y90 TARE, durvalumab and tremelimumab. As a secondary objective, the study will assess the overall efficacy of Y90 in combination with therapty as guaged by patient response rate.
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SUPRAME-ACTengine® IMA203 Vs. Investigator's Choice Of Treatment In Previously Treated, Unresectable Or Metastatic Cutaneous Melanoma
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
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Testicular Tissue Cryopreservation in Children
Rochester, MN
This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.
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Compare the Efficacy and Safety of Golcadomide Plus R-CHOP vs Placebo Plus RCHOP in Participants with Previously Untreated High-risk Large B-cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the investigator.
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Tumor Heterogeneity Of The Tumor Microenvironment In Malignant Pleural Mesothelioma (MPM)
Rochester, MN
The purpose of this study is to:
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Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.
- Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.
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Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Scottsdale/Phoenix, AZ
The primary objective of this trial is to determine safety of the robotic bronchoscopy procedures performed in routine clinical practice at multiple centers. Secondary objectives include overall safety assessment as well as description of diagnostic accuracy of the robotassisted bronchoscopy procedure.
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Virtual Dignity Therapy for Palliative Care Patients with Advanced Cancer
Rochester, MN
The purpose of this study is to determine if it is feasible to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer and whether the intervention is beneficial in terms of improvement in distress, patient dignity, and quality of life.
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A Study to Determine the Effect of Distance Reiki on Patient Reported Quality of Life (PRQoL) and Immunity Among Multiple Myeloma Patients
Rochester, MN
This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients.It also aims to determine if there is a minimal clinically meaningful improvement in various QOL domains (Physical, Social, Emotional), overall QOL with use of Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Single Item Linear Analogue Scale (LASA) after Distance Reik. Lastly, it aims to analyze the effect of Distance Reiki on expansion of the immune repertoire by comparing immune repertoires at baseline and at the end of the study by using Mass spectrometry by CyTOF® and multiplex ...
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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
Rochester, MN
This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life ...
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A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
Rochester, MN
The purpose of this study is to determine how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas.
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Ruxolitinib in Combination with Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.
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Lenalidomide in Improving Immune Response to Vaccine Therapy in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Monoclonal B Cell Lymphocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well lenalidomide improves immune response to pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Lenalidomide may also improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent infection.
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Pharmacogenomic Testing in Patients with Hand-Foot Skin Reaction on Tyrosine Kinase Inhibitors
Scottsdale/Phoenix, AZ
The purpose of this research study is to:
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Find out whether there are any DNA (genetic) changes and mutations that put you at risk of developing this skin reaction and use that information to predict the side effect on patients with similar results in the future.
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Help us better manage the hand-foot skin reaction if it develops by recommending the appropriate treatment
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Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to find out if ginseng decreases fatigue in people who were treated for cancer.
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The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).
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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Rochester, MN; La Crosse, WI
The purpose of this study is to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer.
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Phase 3 Study of Vimseltinib for Tenosynovial Giant Cell Tumor
Rochester, MN
This is a multicenter study which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the ...
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Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
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WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
Rochester, MN
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.
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A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open label, multi-center, Phase Ib dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX or FOLFIRI with and without bevacizumab, or regorafenib.
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Rochester, MN
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Rochester, MN
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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Safety and Efficacy Study of PRI-724 in Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread(metastasize).
Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724 dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.
Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts with CRC will be ...
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A Study of the Safety and Effectiveness of INC280 Alone and in Combination with Erlotinib, When Compared to Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutation and Amplified cMET
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, the next recommended study dose, and the anti-tumor activity and safety of INC280 alone and in combination with erlotinib, when compared to standard platinum with pemetrexed chemotheapy in adult patients who have EGFR mutated and cMET amplified advanced/metastatic non-small cell lung cancer,and have acquired resistance to prior EGFR tyrosine kinase inhibitors.
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A Study to Evaluate Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that has spread to other places of the body or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with ...
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A Study of the Gut Microbiome in Chemotherapy Treatment
Rochester, MN
The purpose of this study is to investigate the impact of microbiome on the effectiveness and toxicity of anti-cancer therapy and to develop microbiome- based markers to personalize cancer treatment.
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Study to Compare the Safety and Effectiveness of Treatment Combinations in Patients with Recurrent Ovarian Cancer
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of the niraparib combinations defined in each cohort-specific supplement, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
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A Study of the Diagnostic Performance of the Nonlinear Elasticity Parameter Mapping Method with Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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A Study to Evaluate Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
La Crosse, WI; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
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A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Jacksonville, FL; Rochester, MN
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
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GPS Compared With BAT in AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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A Study to Analyze Onvansertib Treatment in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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NRG-GY012 “A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, And The Combinations Of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5356 (Capivasertib) In Women With Recurrent, Persistent Or Metastatic Endometrial Cancer. A Multi-Arm Trial For Women With Recurrent Or Persistent Endometrial Cancer”
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Analyze Onvansertib Treatment in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.
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A Study to Evaluate Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
La Crosse, WI; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
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A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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GPS Compared With BAT in AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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Analysis of Live Tumor Fragments of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Study of ALX148 With Azacitidine for Higher Risk Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
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A Study to Explore MRI to Stage Bladder Cancer
Jacksonville, FL
The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.
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Cervical Cancer Screening Among Populations With Health Disparities
Rochester, MN
The purpose of this study is to conduct a survey of Somali and Hispanic women to ascertain personal, cultural, and structural barriers to CCS and assess the acceptability, and appropriateness of community engaged and community-based strategies to increase screening.
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A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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Fucoidan For Patients With Chemotherapy-Related Fatigue
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of fucoidan vs. placebo in preventing fatigue as assessed by a single-item measure of fatigue (Appendix 1, Linear Analog Scale of Fatigue) at 8 weeks following the initiation of platinum-based doublet/triplet.
The Fucoidan dose of 400 mg formulation is specifically being made for this trial.
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Methadone versus Intrathecal Hydromorphone for Analgesia Patients Undergoing Surgery for Gynecologic Malignancy via Midline Laparotomy Receiving Liposomal Bupivacaine
Rochester, MN
The purpose of this study is to determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. Our overall purpose is to identify the most effective and least invasive manner in which to achieve adequate postoperative analgesia in patients undergoing major gynecologic oncological surgery.
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A Study to Evaluate Contouring Organs at Risk for Treatment Planning
Rochester, MN
The purpose of this study is to determine: if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing. These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow.
Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations ...
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Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
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A Study to Evaluate Tadalafil and Lenalidomide with or without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Jacksonville, FL
This research is being done to find out if altering the immune system by giving Prevnar vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
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AKT Inhibitor MK2206, Combined with Bendamustine Hydrochloride, and Rituximab for Treating Patients who have Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
The purpose of this study is is to assess the side effects and best dose of akt inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab, and to see how well they work in treating patients with treatment resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, ...
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
Rochester, MN
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
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Low-Dose or High-Dose Lenalidomide in Treating Children with Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
Rochester, MN
This randomized phase II trial studies how well low-dose lenalidomide works compared with high-dose lenalidomide in treating children with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
Rochester, MN
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin ...
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Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy
Rochester, MN
The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
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Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Evaluate the Effectiveness and Safety of UGN-101 in Patients with Recurrent Upper Urinary Tract Urothelial Carcinoma
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit, and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).
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Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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Durvalumab+/- Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
Scottsdale/Phoenix, AZ
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer.
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A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in Participants With Advanced Upper Gastrointestinal Tract Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL
This Phase 2, open-label, parallel, 3-cohort, multicenter study will evaluate the safety and efficacy of various combinations of the anti-T-cell immunoglobulin and ITM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first--line setting, and of various combinations of domvanalimab, zimberelimab, the cluster of differentiation 73 (CD73) inhibitor quemliclustat, and chemotherapy in the second-line (2L) or greater setting in participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
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Comparing Retreatment Of 177Lu-DOTATATE PRRT Versus Everolimus In Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial
Scottsdale/Phoenix, AZ
The purpose of this study is tol compare the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable).
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A Study to Evaluate Artificial Intelligence-driven Assistance for Treatment Planning in Radiation Oncology
Rochester, MN
The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.
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Bendamustine Hydrochloride and Rituximab with or without Bortezomib Followed by Rituximab with or without Lenalidomide in Treating Patients with High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and ...
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A Study To Test The Addition Of The Drug Cabozantinib To Chemotherapy In Patients With Newly Diagnosed Osteosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill ...
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Pilot Study of Care at Home for Monitoring Brain Tumor Patients
Rochester, MN
The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.
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A Study to Evaluate A Resilient Living Program for Patients with Advancer Cancer and Their Caregivers
Rochester, MN
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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Study Of SX-682 Alone And In Combination With Oral Or Intravenous Decitabine In Subjects With Myelodysplastic Syndrome
Jacksonville, FL
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Learning From Patients How They Were Educated On Chemotherapy Side Effects
Rochester, MN
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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Combination Chemotherapy in Treating Patients with Non-Metastatic Extracranial Ewing Sarcoma
Rochester, MN
This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
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Ruxolitinib Phosphate (Oral JAK Inhibitor INCB18424) in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well giving ruxolitinib phosphate (oral JAK inhibitor INCB18424) works in treating patients with relapsed or refractory diffuse large B-cell or peripheral T-cell non-hodgkin lymphoma and are ineligible to stem cell transplant or have recurrent disease after stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Lenalidomide and AT-101 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Jacksonville, FL
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
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A Phase 1 Dose Escalation and Expansion Study of TGR-1202 + Ruxolitinib in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, or Polycythemia Vera Resistant to Hydroxyurea
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
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Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Rochester, MN
This randomized phase II trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective ...
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Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
Rochester, MN
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
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Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.
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A Study to Assess AC220 Given in Combination with Induction and Consolidation Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML)
Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
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A Study to Assess the Safety and Tolerability of ADI-PEG 20 Combined with Pemetrexed and Cisplatinin in Subjects with Tumors Requiring Arginine
Rochester, MN
The purpose of this study is to assess the safety and tolerability of ADI-PEG 20 combined with pemetrexed and cisplatin in patients with tumors requiring arginine such as advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non squamous non-small cell lung cancer (stage IIIB/IV), metastatic uveal melanoma, advanced liver cell cancer or recurrent high-grade glioma.
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A Study Using Docetaxel with or without MLN1117 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose of MLN1117 when administered in combination with docetaxel in patients with non-small cell lung cancer and to evaluate the effectiveness, safety, and tolerability of MLN1117 when given alone and in combination with docetaxel in patients with locally advanced or metastatic non-small cell lung cancer.
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An Extension Study to Evaluate Subjects Who Have Benefited from Previous Treatment with Niraparib
Jacksonville, FL
The purpose of this study is to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment.
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A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the effectiveness of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.
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Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well combination chemotherapy and pralatrexate works in treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
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Metabolic Agents Pharmacodynamic Analyses After Brain Radiation
Rochester, MN
Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate). Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate).
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A Study of the Safety and Effectiveness of Using Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Jacksonville, FL
The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure during induction chemotherapy for patients with acute myeloid leukemia (AML).
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A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
Jacksonville, FL
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.
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A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or those with liver metastasis from other cancers. The drug is given intravenously, twice per week for three weeks in a row and then one week off. Additionally patients with hematologic malignancies will be evaluated on a treatment schedule of five days in a row with two weeks off.
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Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Rochester, MN
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
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Musical Toxicity's Effect on Patient During Cancer Treatment
Rochester, MN
The purpose of this study is to produce a rich description of musicians’ experience as they go through cancer treatment and navigate recovery.
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Temozolomide and Irinotecan Hydrochloride with or without Bevacizumab in Treating Young Patients with Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
Rochester, MN
This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells ...
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Brightline-1: A Study to Compare Bi 907828 With Doxorubicin In People With a Type of Cancer Called Dedifferentiated Liposarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer.
Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and ...
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A Study to Evaluate Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors
Rochester, MN
The purpose of this study is to evaluate how well bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study to Evaluate 9-ING-41 As a Single Agent or in Combination with Ruxolitinib in Myelofibrosis Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness of 9-ING-41, either by itself or in combination with Ruxolitinib, in patients with advanced myelofibrosis. 9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has both pre-clinical anti-fibrotic activity and activity against myelofibrosis. 9-ING-41 may reduce the dose of Ruxolitinib needed for optimal therapeutic response and/or reverse myelosuppression so than an adequate dose of Ruxolitinib can be tolerated for an adequate duration to confer an optimal therapeutic outcome.
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Combination Chemotherapy in Treating Younger Patients with Newly Diagnosed, Non-Metastatic Desmoplastic Medulloblastoma
Rochester, MN
This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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A Study of Performing Surgery for Resectable Malignant Pleural Mesothelioma After Radiation Therapy
Rochester, MN
The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.
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A Study Using Clofarabine and Cytarabine in Treating Children with Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
No Locations
Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
The purpose of this trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
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Short-course Radiation Therapy for Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).
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A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.
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Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Empty Bladder Impact During Radiation Therapy for Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether an empty bladder during radiation therapy delivery for prostate cancer affects patient-reported urinary symptoms related to treatment.
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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Jacksonville, FL
The purpose of this study is to test whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts.
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A Study of Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer
La Crosse, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaouate how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.
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Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.
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A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
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Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will ...
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Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them ...
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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A Study of Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia
Rochester, MN
The purpose of this study is to assess the effectiveness and long term side effects of using combined tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by ...
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A Study To Investigate The Safety And Tolerability Of Ziftomenib In Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, Or 7+3+Quizartinib In Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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Lenalidomide or Observation in Treating Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
Rochester, MN
This phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.
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A Study To Compare Standard Chemotherapy To Therapy With CPX-351 And/or Gilteritinib To To Treat Newly-diagnosed AML With Or Without FLT3 Mutations
Rochester, MN
The purpose of this study is to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
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Analyses Of Metabolic Agents Following Brain Radiation
Rochester, MN
The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.
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DNA Damage Using HERY-MNT Technology Can Predict Chemotherapy Induced Toxicity In Women With Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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Long-Term Follow-Up Of Patients Who Have Participated In Children's Oncology Group Studies
Rochester, MN
This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.
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Pilot Study of Care at Home for Monitoring Brain Tumor Patients
Rochester, MN
The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.
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A Study to Evaluate A Resilient Living Program for Patients with Advancer Cancer and Their Caregivers
Rochester, MN
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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Study Of SX-682 Alone And In Combination With Oral Or Intravenous Decitabine In Subjects With Myelodysplastic Syndrome
Jacksonville, FL
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Learning From Patients How They Were Educated On Chemotherapy Side Effects
Rochester, MN
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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Combination Chemotherapy in Treating Patients with Non-Metastatic Extracranial Ewing Sarcoma
Rochester, MN
This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
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Ruxolitinib Phosphate (Oral JAK Inhibitor INCB18424) in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well giving ruxolitinib phosphate (oral JAK inhibitor INCB18424) works in treating patients with relapsed or refractory diffuse large B-cell or peripheral T-cell non-hodgkin lymphoma and are ineligible to stem cell transplant or have recurrent disease after stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Lenalidomide and AT-101 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Jacksonville, FL
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
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A Phase 1 Dose Escalation and Expansion Study of TGR-1202 + Ruxolitinib in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, or Polycythemia Vera Resistant to Hydroxyurea
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
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A Study to Assess AC220 Given in Combination with Induction and Consolidation Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML)
Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
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A Study to Assess the Safety and Tolerability of ADI-PEG 20 Combined with Pemetrexed and Cisplatinin in Subjects with Tumors Requiring Arginine
Rochester, MN
The purpose of this study is to assess the safety and tolerability of ADI-PEG 20 combined with pemetrexed and cisplatin in patients with tumors requiring arginine such as advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non squamous non-small cell lung cancer (stage IIIB/IV), metastatic uveal melanoma, advanced liver cell cancer or recurrent high-grade glioma.
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Study of Cisplatin-Induced Peripheral Neuropathy in Patients with Germ Cell Tumor
Rochester, MN
The purpose of this study is to investigate the incidence, characteristics of, and changes in chronic neuropathy symptoms related to cisplatin and evaluate the natural history of platinum induced peripheral neuropathy during active treatment and the first 12 months post chemotherapy.
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Cisplatin and Gemcitabine Hydrochloride With or Without ATR Kinase Inhibitor VX-970 in Treating Patients With Metastatic Urothelial Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer that has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin ...
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A Study to Evaluate The Effect of Diet and Exercise on Biomarkers Associated with Obesity and Breast Cancer in Overweight Women with Early Stage Breast Cancer
Rochester, MN
The primary purpose of this study is to investigate the relationship between a technology-assisted diet and exercise program which is easily implemented in an outpatient setting and the levels of biomarkers that have been associated with breast cancer recurrence risk in overweight women with stage 0, I, or II breast cancer.
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Phase 3 Study of Vimseltinib for Tenosynovial Giant Cell Tumor
Rochester, MN
This is a multicenter study which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the ...
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Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
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WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
Rochester, MN
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.
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A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open label, multi-center, Phase Ib dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX or FOLFIRI with and without bevacizumab, or regorafenib.
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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
Rochester, MN
This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life ...
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A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
Rochester, MN
The purpose of this study is to determine how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Rochester, MN
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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Safety and Efficacy Study of PRI-724 in Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread(metastasize).
Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724 dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.
Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts with CRC will be ...
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A Study of the Safety and Effectiveness of INC280 Alone and in Combination with Erlotinib, When Compared to Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutation and Amplified cMET
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, the next recommended study dose, and the anti-tumor activity and safety of INC280 alone and in combination with erlotinib, when compared to standard platinum with pemetrexed chemotheapy in adult patients who have EGFR mutated and cMET amplified advanced/metastatic non-small cell lung cancer,and have acquired resistance to prior EGFR tyrosine kinase inhibitors.
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A Study to Evaluate Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that has spread to other places of the body or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with ...
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A Study of the Gut Microbiome in Chemotherapy Treatment
Rochester, MN
The purpose of this study is to investigate the impact of microbiome on the effectiveness and toxicity of anti-cancer therapy and to develop microbiome- based markers to personalize cancer treatment.
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Study to Compare the Safety and Effectiveness of Treatment Combinations in Patients with Recurrent Ovarian Cancer
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of the niraparib combinations defined in each cohort-specific supplement, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
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A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Jacksonville, FL; Rochester, MN
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Rochester, MN
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
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A Study of the Diagnostic Performance of the Nonlinear Elasticity Parameter Mapping Method with Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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A Study to Evaluate Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
La Crosse, WI; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
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A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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GPS Compared With BAT in AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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A Study to Analyze Onvansertib Treatment in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.
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NRG-GY012 “A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, And The Combinations Of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5356 (Capivasertib) In Women With Recurrent, Persistent Or Metastatic Endometrial Cancer. A Multi-Arm Trial For Women With Recurrent Or Persistent Endometrial Cancer”
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Analysis of Live Tumor Fragments of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Study of ALX148 With Azacitidine for Higher Risk Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
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A Study to Explore MRI to Stage Bladder Cancer
Jacksonville, FL
The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.
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Cervical Cancer Screening Among Populations With Health Disparities
Rochester, MN
The purpose of this study is to conduct a survey of Somali and Hispanic women to ascertain personal, cultural, and structural barriers to CCS and assess the acceptability, and appropriateness of community engaged and community-based strategies to increase screening.
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A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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Fucoidan For Patients With Chemotherapy-Related Fatigue
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of fucoidan vs. placebo in preventing fatigue as assessed by a single-item measure of fatigue (Appendix 1, Linear Analog Scale of Fatigue) at 8 weeks following the initiation of platinum-based doublet/triplet.
The Fucoidan dose of 400 mg formulation is specifically being made for this trial.
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Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
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A Study to Evaluate Tadalafil and Lenalidomide with or without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Jacksonville, FL
This research is being done to find out if altering the immune system by giving Prevnar vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
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AKT Inhibitor MK2206, Combined with Bendamustine Hydrochloride, and Rituximab for Treating Patients who have Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
The purpose of this study is is to assess the side effects and best dose of akt inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab, and to see how well they work in treating patients with treatment resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, ...
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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Methadone versus Intrathecal Hydromorphone for Analgesia Patients Undergoing Surgery for Gynecologic Malignancy via Midline Laparotomy Receiving Liposomal Bupivacaine
Rochester, MN
The purpose of this study is to determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. Our overall purpose is to identify the most effective and least invasive manner in which to achieve adequate postoperative analgesia in patients undergoing major gynecologic oncological surgery.
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Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
Rochester, MN
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin ...
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Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy
Rochester, MN
The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
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A Study to Evaluate Contouring Organs at Risk for Treatment Planning
Rochester, MN
The purpose of this study is to determine: if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing. These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow.
Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations ...
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
Rochester, MN
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
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Low-Dose or High-Dose Lenalidomide in Treating Children with Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
Rochester, MN
This randomized phase II trial studies how well low-dose lenalidomide works compared with high-dose lenalidomide in treating children with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.
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Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Evaluate the Effectiveness and Safety of UGN-101 in Patients with Recurrent Upper Urinary Tract Urothelial Carcinoma
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit, and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).
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A Study to Evaluate Artificial Intelligence-driven Assistance for Treatment Planning in Radiation Oncology
Rochester, MN
The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.
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Bendamustine Hydrochloride and Rituximab with or without Bortezomib Followed by Rituximab with or without Lenalidomide in Treating Patients with High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and ...
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Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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Changes in Blood Components in Patients with Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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Turkey Tail Mushroom For Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.
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A Study Of Biomarkers To Predict Cancer Therapy-related Cardiotoxicity
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to collect Biospecimens from patients who developed chemotherapy related cardiac toxicity (CRCT) and patients who are at a high risk for developing CRCT identified prior to the onset of therapy.
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Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB ...
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Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Eau Claire, WI; Mankato, MN
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
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A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Rochester, MN
This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.
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IL-2 plus FOLFOX and Nivolumab for Treatment of Peritoneal Metastases
Rochester, MN
The purpose of this study is to evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment.
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Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors.
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A Study to Evaluate Effectiveness and Quality of Life Outcomes of Daratumumab in Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The primary purpose of this study is to evaluate patient-reported health-related quality of life outcomes in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) treated with daratumumab-based regimens in a real life setting.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Non-squamous NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
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177Lu-DTPA-Omburtamab Radioimmunotherapy toTreat Recurrent or Refractory Medulloblastoma
Rochester, MN
The purpose of this study is to assess 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3, to treat children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy.
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Study of INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this Phase I/IIA, open-label, multi-center trial is to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population is divided into two cohorts: Cohort A: Participants with locally advanced unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or following treatment with anti-Programmed Death receptor-1/Programmed Death receptor Ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: Participants with locally advanced unresectable or metastatic/recurrent UCa, who are treatment naïve and ineligible for ...
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A Study of Cell, Serum, and Bone Marrow Bank for Patients receiving Chimeric Antigen Receptor T Cell Therapy for the Treatment of Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to store blood, serum and bone marrow so that they can be used for laboratory studies that may contribute to finding the exact function of the CART cells or T-cell engager therapy such as bispecific and trispecific antibodies and the factors that may determine disease progression and treatment response.
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Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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Study of Oraxol and Pembrolizumab in Subjects with Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine dose escalation of paclitaxel administered as Oraxol in combination with Pembrolizumab, and dose expansion to assess the ORR per Response Evaluation Criteria in subjects with advanced Solid Tumors, Urothelial Carcinoma, Gastric cancer, Gastro-esophageal cancer, and Non-small cell lung cancer.
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A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.
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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Rochester, MN
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
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A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.
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Methotrexate, Erlotinib, And Celecoxib For The Treatment Of Recurrent/Metastatic Oral Cavity Cancer In A Rural Midwest United States Population
Rochester, MN
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by ...
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A Study to Evaluate Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction/Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer
La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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A Phase 2/3 Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Subjects With Unresectable or Metastatic Melanoma
Rochester, MN
This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial.
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ACP-196 in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Rochester, MN; Jacksonville, FL
The purpose of this study is to characterize the safety profile of acalabrutinib and pembrolizumab in subjects with hematologic malignancies.
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A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
Scottsdale/Phoenix, AZ
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).
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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Mankato, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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A Study Evaluating Pembrolizumab and Epacadostat in Treating Participants With Recurrent, Persistent, or Progressive Ovarian Clear Cell Carcinoma
Rochester, MN
The purpose of this trial is to assess how well pembrolizumab and epacadostat work in treating participants with ovarian clear cell carcinoma that has come back, remains despite treatment, or is growing, spreading, or getting worse. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better in treating participants with ovarian clear cell carcinoma.
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Avelumab With Binimetinib, Sacituzumab Govitecan, Or Liposomal Doxorubicin In Treating Patients With Stage IV Or Unresectable, Recurrent Triple Negative Breast Cancer
Rochester, MN
The purpose of this study is to evaluate how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent).
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Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
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T-DM1 vs Paclitaxel/Trastuzumab for Breast
Rochester, MN
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) ...
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Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.
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Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
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A Study of Grapiprant and Pembrolizumab in Patients with Advanced or Progressive MSS Colorectal Cancer
Scottsdale/Phoenix, AZ
This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. The purpose of this study is to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.
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Exercise Preconditioning and Breast Cancer Cardiotoxicity
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction (pre-conditioning) and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.
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Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Rochester, MN; Rochester, MN
Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
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A Study to Evaluate Lasofoxifene versus Fulvestrant in Advanced or Metastatic ER+/HER2− Breast Cancer Patients with an ESR1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2−) breast cancer with an ESR1 mutation.
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Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Jacksonville, FL
The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.
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A Study of the Effectiveness and Safety of Pembrolizumab (MK-3475) for Women with Advanced Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of pembrolizumab (MK-3475) for the treatment of women with advanced ovarian cancer who have had recurring disease following front line platinum-based treatment and debulking surgery.
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Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma
Jacksonville, FL; Rochester, MN
The purpose of this randomized phase I/II trial is to study the side effects and how well pembrolizumab with or without anetumab ravtansine work in treating patients with mesothelin-positive pleural mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
Rochester, MN
This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or is locally advanced and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones made by the body and they can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone ...
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A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab
Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
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A Study to Evaluate Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients with Chronic Myeloid Leukemia and Persistently- Detectable Minimal Residual Disease
Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic myeloid ...
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Study Treating Patients with Relapsed or Refractory Aggressive B-cell Lymphomas Using Nivolumab with or without Varlilumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating the immune system to attack cancer tumor cells.
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Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) or progression-free survival (PFS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.
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A Study to Evaluate UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to explore the effectiveness and safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.
UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma.
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A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.
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Genetic Risk Estimation and Improving Health Disparities in Breast Cancer Screening of Racial Minorities
Jacksonville, FL
The aim of this study is to use the combine clinical risk assessment models that are already used in routine clinical practice with information derived from polygenic risk score (PRS) testing in women of racial minorities to see if this can improve adherence to recommended breast cancer screening and prevention strategies.
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Study of Pembrolizumab With Ipilimumab or Placebo in Participants with Untreated Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
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A Study to Evaluate the Addition of Immunotherapy into Adjuvant Therapy for Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma (SEQUEL)
Rochester, MN
This is a randomized Phase 2 study of novel SEQUEnced immunotherapy (pembrolizumab) with anti-angiogenesis and chemotherapy in advanced gastric and gastroesophageaL junction (GEJ) adenocarcinoma (SEQUEL) designed to to evaluate the best overall response rate (BORR) of combined ramucirumab (RAM) plus paclitaxel (+/- pembrolizumab) following induction pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma.
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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess if camizestrant improves outcomes compared to standard endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).
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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess if camizestrant improves outcomes compared to standard endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).
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A Study to Test the Addition of Nivolumab to Chemotherapy to Treat Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor ...
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A Study to Evaluate the Addition of Immunotherapy into Adjuvant Therapy for Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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A Study of Combination Chemotherapy for Treating Women with Stage II or Stage IIIA Breast Cancer that has Spread to the Lymph Nodes
Eau Claire, WI
The purpose of this study is to compare the effectiveness of two different combinations of chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
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Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM
Rochester, MN
The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and effective in adults with MPM who have failed prior anti-cancer therapy.
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Therapeutic Drug Monitoring of Pembrolizumab and Nivolumab to Determine Dosages for Cancer Treatment
Rochester, MN
Drug monitoring of Pembrolizumaband Nivolumab for determining the pharmacokinetic (PK) profile of these medications and to provide information for dose adjustments to guide physicians in the future.
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Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.
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Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).
Scottsdale/Phoenix, AZ
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC
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Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Estrogen Receptor Positive (ER+) Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded ...
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Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer
Rochester, MN
This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
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Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer
Rochester, MN
This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment
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An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Rochester, MN
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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A Study of a Personalized Neoantigen Cancer Vaccine
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
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Changes in GI Inflammation and the GI Microbiome Profile in Women With Breast Cancer Throughout Chemotherapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy. Also, to examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
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Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
Scottsdale/Phoenix, AZ; Rochester, MN
This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents
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Preventing Anthracycline Cardiovascular Toxicity with Statins (PREVENT)
Rochester, MN
The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in women who are receiving anthracycline-based chemotherapy for breast cancer.
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A Study to Evaluate Preoperative Oral Microbiota-Based Investigational New Drug to Target Immune Response in Patients with Operable Stage I-III Breast Cancer
Jacksonville, FL
The primary purposes of this trial are to determine the safety and tolerability of RBX7455 given for at least 2 weeks and not more than 4 weeks prior to surgery, and to evaluate intratumoral immune system resonse, including TILs, CD4, and CD8 T cells, in operable breast cancer patients.
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A Study to Evaluate the Effects of Exercise on Fatigue in Thyroid Cancer Survivors
Rochester, MN
The purpose of this study is to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients, and to determine the effect of a home-based program compared to a center- based program.
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Cytotoxic Activity of Lenalidomide in Combination with the Bispecific CD30/CD16a Therapeutic Monoclonal Antibody, AFM13
Jacksonville, FL
The purpose of this study is to determine whether lenalidomide enhances the activation potential of NK cells derived from Hodgkin’s lymphoma patients. The study also aims to determine if lenalidomide treated NK cells are more efficient in killing CD30+ tumor cells (cancer cell lines) in combination with an investigational agent (AFM13, CD30/CD16a mAb, Affimed Therapeutics, Germany), which engages both the CD30+ tumor cell and CD16a+ NK cells.
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Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
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Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma
Rochester, MN
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.
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Melanoma Relatlimab Nivolumab
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread
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Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)
Rochester, MN; Jacksonville, FL
The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.
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Screening for High Frequency Malignant Disease
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.
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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
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A Study to Evaluate Adjuvant Ado-Trastuzumab Emtansine (T-DM1) in HER2 Positive Breast Cancer
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
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Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.
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Veliparib with or without Carboplatin in Treating Patients with Stage III or Stage IV Breast Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II trial is studying giving veliparib together with carboplatin to see how well they work compared to veliparib alone in treating patients with stage III or stage IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.
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A Study of Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.
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A Study to Evaluate the Effectiveness of M7824 Monotherapy in Locally Advanced or Metastatic Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
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A Study of APR-246 and Pembrolizumab in Patients with Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
La Crosse, WI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Eau Claire, WI
This randomized phase III trial studies combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
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Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Rochester, MN
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
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Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Rochester, MN
To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma
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Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
Rochester, MN
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
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A Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Platinum-Refractory Metastatic Bladder Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of combining ACP-196 and Pembrolizumab in subjects with platinum resistant metastatic bladder cancer.
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Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Rochester, MN
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
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Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Rochester, MN
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
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A Study to Understand the Connections of Genetic Variation and Mammographic Density within the Mountain Park Health Center Mammography Study
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to understand the causes of breast cancer, in particular the connection between genetic variations and breast density or how tissue is distributed on a mammogram.
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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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Trial of Measles Virotherapy in Combination With Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer
Rochester, MN
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with nivolumab in patients with recurrent and metastatic (NSCLC).
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MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease ...
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Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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A Study to Evaluate the Effectiveness of M7824 Monotherapy in Locally Advanced or Metastatic Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
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Trial of Measles Virotherapy in Combination With Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer
Rochester, MN
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with nivolumab in patients with recurrent and metastatic (NSCLC).
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MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease ...
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
Jacksonville, FL
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and effectiveness of AZD0466 as monotherapy in participants with advanced haematological malignancies, and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.
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Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
Rochester, MN
This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL).
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Spinal Cord Stimulation to Treat Chemotherapy-Induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to understand pain outcomes in patients with cancer who have Chemotherapy-Induced Peripheral Neuropathy (CIPN).
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A Study to Determine Recommended Dose, Regimen and Evaluate the Safety and Preliminary Effectiveness of CC-92480 in Combination With Standard Treatments in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Rochester, MN
The purpose of this study is to learn about the effects of a research medicine called AFM13 and to see how well AFM13 is tolerated.
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Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Rochester, MN; Jacksonville, FL
The purpose of this study is to describe, under real-world conditions, the safety and effectiveness of larotrectinib in patients with locally advanced or metastaticTRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment.
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Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow down the growth and/or progression of the tumors of participants with relapsed or recurrent Small Cell Lung Cancer.
This study also plans to find out what effects, good or bad (side effects), OSI-906 has on participants and or Small Cell Lung Cancer. The study will also investigate if some proteins measured in the blood or tumor and some imaging features obtained from computed tomography (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small Cell Lung Cancer.
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A Study of Combination Radiation Therapy and Cisplatin with or without Triapine for Treating Patients with Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to see how well radiation therapy and cisplatin with triapine work in combination compared to the standard radiation therapy and cisplatin alone to treat patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Triapine may stop the growth of tumor cells ...
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Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Rochester, MN
The purpose of this trial is to investigate the clinical effectiveness of the combination of pembrolizumab and lenvatinib in patients with recurrent or persistent clear cell carcinoma of the ovary (CCOC) as measured by the multiple primary endpoints of objective response rate (ORR) and rate of PFS at 6 months (PFS6) per RECIST 1.1.
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Study Of CG0070 Given In Combination With Pembrolizumab, In Non Muscle Invasive Bladder Cancer, Unresponsive To Bacillus Calmette-Guerin
Rochester, MN
The primary purpose of this study is to evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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A Study to Compare Elacestrant vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer
Rochester, MN
The purpose of this study is to compare the effectiveness and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .
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A Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Rochester, MN
The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT
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Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production
Rochester, MN
The purpose of this study is to investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production.
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STI-3031 Through Sofusa DoseConnect for Treatment of Intransit Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this phase trial is to identify the best dose of STI-3031 that can be administered through the DoseConnect device in treating patients with melanoma that is visibly metastasizing (spreading to other parts of the body. This condition is referred to as "in-transit metastases" or "ITM." Immunotherapy with STI-3031 may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Rochester, MN
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
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Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Rochester, MN
Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
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Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Rochester, MN
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
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Single arm pilot trial of adaptive therapy (AT) with capecitabine for the treatment of breast cancer
Scottsdale/Phoenix, AZ
In this study, we propose a new way of giving chemotherapy, called Adaptive Therapy (AT) using capecitabine. The goal is to prove feasibility as well as safety of this approach. We will test adaptive therapy in 35 metastatic breast cancer patients diagnosed with ER+ disease but for whom endocrine therapies have failed and use of chemotherapy is appropriate. We will recruit participants at Mayo Clinic Arizona. Chemotherapy will be given orally in an adaptive fashion, which means we will adjust the dose of the chemotherapy according to the response of the tumor. Response is measured by imaging done ...
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Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Jacksonville, FL
The purpose of this study is to investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home. The secondary intent is to investigate overall patient satisfaction with the Care Hotel Model.
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A Study of Copanlisib and Nivolumab in Treating Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate how well copanlisib and nivolumab work in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
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An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants (PATAPSCO)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of durvalumab (1500 mg iv for 13 cycles every four weeks (q4w) + BCG (induction and maintenance) combination therapy by assessment of Grade 3/4 PRAEs in high-risk NMIBC participants.
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A Study to Evaluate Mutanome-directed Immunotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of multiple subcutaneous injections of a mutanome-directed active immunotherapy (TG4050) in patients with newly-diagnosed, locoregionally advanced, HPV-negative Squamous Cell Carcinoma of the Head and Neck (SCCHN) initiated at completion of primary treatment (Arm A) or at the time of recurrence (Arm B)
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A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Jacksonville, FL
The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.
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Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment
Rochester, MN
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast cancer (primary tumor >1 cm).
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Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase I/II trial studies the best dose and side effects of anetumab ravtansine when given together with atezolizumab and how well they work in treating participants with non-small cell lung cancer that has spread to other places in the body. Monoclonal antibodies, such as anetumab ravtansine and atezolizumab, may interfere with the ability of tumor cells to grow and spread.
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Open-Label Study of PEGPH20 With CIS and GEM; PEGPH20 With Atezolizumab, CIS and GEM; and Compared With CIS and GEM Alone in HA-high Subjects With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Scottsdale/Phoenix, AZ
The study was conducted to assess the safety and tolerability of (1) polyethylene glycol (PEG) PEGylated Recombinant Human Hyaluronidase (PEGPH20) in combination with cisplatin (CIS) and gemcitabine (GEM) (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO).
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Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Rochester, MN
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with enzalutamide may be a better treatment for patients with breast cancer.
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Neoadjuvant Pembrolizumab
Rochester, MN
This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer ...
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Phase 1b Open-Label Study of PEGPH20 With Pembrolizumab
Scottsdale/Phoenix, AZ
This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) subjects with relapsed/refractory Non-Small Cell Lung Cancer (NSCLC) and HA-high subjects with relapsed/refractory gastric adenocarcinoma.
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Prehabilitation
Rochester, MN
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer ...
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A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma - the ImmuneSense Study
Jacksonville, FL
The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma multiforme (GBM) participants treated with IGV-001 as compared with placebo.
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Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study is to compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT -To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT; to compare the effect of adjuvant cemiplimab with that of placebo on patients' ...
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Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
Jacksonville, FL; Rochester, MN
The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...
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A Study of Copanlisib and Nivolumab in Treating Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate how well copanlisib and nivolumab work in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
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Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Jacksonville, FL
The purpose of this study is to investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home. The secondary intent is to investigate overall patient satisfaction with the Care Hotel Model.
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Single arm pilot trial of adaptive therapy (AT) with capecitabine for the treatment of breast cancer
Scottsdale/Phoenix, AZ
In this study, we propose a new way of giving chemotherapy, called Adaptive Therapy (AT) using capecitabine. The goal is to prove feasibility as well as safety of this approach. We will test adaptive therapy in 35 metastatic breast cancer patients diagnosed with ER+ disease but for whom endocrine therapies have failed and use of chemotherapy is appropriate. We will recruit participants at Mayo Clinic Arizona. Chemotherapy will be given orally in an adaptive fashion, which means we will adjust the dose of the chemotherapy according to the response of the tumor. Response is measured by imaging done ...
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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Rochester, MN
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
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Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
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An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Jacksonville, FL; Rochester, MN
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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LEGEND Study: A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of intravesical administration of EG-70 and in the bladder and its effect on bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC).
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Genetics of Chemotherapy-Related Amenorrhea in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to assess genetic predictors of chemotherapy-related amenorrhea in breast cancer survivors of both European and non-European ancestry.
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A Study to Evaluate PDS0101 and Pembrolizumab Combination to Treat Subjects with HPV16 + Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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A Study to Test Nivolumab with Usual Chemotherapy Treatment or Usual Chemotherapy Treatment Alone to Treat Recurrent or Metastatic Nasopharyngeal Cancer
Jacksonville, FL
The purpose of this study is to compare the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus the usual chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by ...
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A Study to Assess Dendritic Cell Immunotherapy Plus Standard-of-Care to Treat Advanced Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate CMN-001 in a randomized trial between standard-of-care (SOC) (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-001.
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Phase 1 Study of Oral TP-1454
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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NL-201 in Patients With Relapsed or Refractory Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.
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A Study to Evaluate DS-1062a Combined with Pembrolizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
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A Study of Pembrolizumab Alone or Combined with CC-486 for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer
Rochester, MN
The purpose of the study is to determine the best dose of CC-486 (oral azacitidine) combined with pembrolizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.
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Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
Scottsdale/Phoenix, AZ; Rochester, MN; Rochester, MN
In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as ...
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A Study to Evaluate Pembrolizumab, Ixazomib Citrate, and Dexamethasone to Treat Participants with Relapsed Multiple Myeloma
Rochester, MN
This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating participants with multiple myeloma that has come back. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together ...
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I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more cancer cells.
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A Study of Chemotherapy-induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to collect clinical and biomarker data from patients receiving neurotoxic chemotherapy who are at risk for developing Chemotherapy-induced Peripheral Neuropathy (CIPN).
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M6620 First in Human Study
Scottsdale/Phoenix, AZ; Rochester, MN
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors
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A Study to Evaluate Pemetrexed and Pembrolizumab to Treat Recurrent and/or Metastatic Salivary Gland Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).
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Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Rochester, MN
RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.
PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
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A Study of ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness, safety, biological activity, and drug/body interactions of ACP-196 alone and combined with Pembrolizumab for the treatment of patients who have advanced or metastatic pancreatic cancer.
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A Phase 2 Study of Anti-PD-L1 Antibody Atezolizumab in Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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A Study to Evaluate Pembrolizumab for Surgically Treated Adjuvant Merkel Cell Carcinoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; La Crosse, WI; Eau Claire, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study to Evaluate Gemcitabine and MK-3475 (Pembrolizumab) to Treat Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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Immune Predictors of Response to Pembrolizumab Therapy in Stage IV Melanoma Patients
Rochester, MN
This study will test whether immune functions in individual cancer patients can be characterized in a quantitative manner using new technologies that analyze nucleic acids from peripheral blood cells and whether those quantitations can be used to predict the response outcomes of patients being treated with Pembrolizumab.
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A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Rochester, MN
The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective multicenter single-arm observational study
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.
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Patient Self-sampling of HPV to Screen for Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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An Early Access Program (EAP) for Avapritinib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this expanded access program is to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
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A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)
Rochester, MN
This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.
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Lung Nodule Management And Lung Cancer Screening In Patients With Abnormal Ct-Scan
Jacksonville, FL
The purpose of this study is to assess the current rate of adherence to incidental lung nodule management and lung cancer screening guidelines in at-risk lung cancer patients identified from chart review.
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A Study to Test the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
Rochester, MN
The purpose of this study is to determine how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs ...
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Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
Jacksonville, FL
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
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Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
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A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to define the recommended dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent Non-Hodgkin's Lymphoma (NHL).
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A Study of Atezolizumab Alone or Combined with Immunomodulatory Drug and/or Daratumumab in Multiple Myeloma Patients
Jacksonville, FL
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.
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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Jacksonville, FL
This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.
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Study Of Carboplatin And Mirvetuximab Soravtansine In First-Line Treatment Of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube Or Primary Peritoneal Cancer
Rochester, MN
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive ...
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STOP-HER2: Stopping Trastuzumab in HER2+ MBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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A Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer
Rochester, MN
The purpose of this study is to determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.
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Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study to Evaluate Adjuvant Ado-Trastuzumab Emtansine (T-DM1) in HER2 Positive Breast Cancer
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
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Veliparib with or without Carboplatin in Treating Patients with Stage III or Stage IV Breast Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II trial is studying giving veliparib together with carboplatin to see how well they work compared to veliparib alone in treating patients with stage III or stage IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.
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A Study of Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.
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A Study to Evaluate the Effectiveness of M7824 Monotherapy in Locally Advanced or Metastatic Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
La Crosse, WI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Eau Claire, WI
This randomized phase III trial studies combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
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A Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Platinum-Refractory Metastatic Bladder Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of combining ACP-196 and Pembrolizumab in subjects with platinum resistant metastatic bladder cancer.
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Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Rochester, MN
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
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Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Rochester, MN
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
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A Study of APR-246 and Pembrolizumab in Patients with Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.
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Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Rochester, MN
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
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Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Rochester, MN
To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma
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Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
Rochester, MN
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
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A Study to Understand the Connections of Genetic Variation and Mammographic Density within the Mountain Park Health Center Mammography Study
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to understand the causes of breast cancer, in particular the connection between genetic variations and breast density or how tissue is distributed on a mammogram.
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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
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Trial of Measles Virotherapy in Combination With Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer
Rochester, MN
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with nivolumab in patients with recurrent and metastatic (NSCLC).
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MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease ...
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Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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A Study to Evaluate TVB-2640 and Trastuzumab Plus Paclitaxel or Endocrine Therapy for Treating Patients with HER2 Positive Advanced Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This phase II trial studies how well FASN inhibitor TVB-2640 and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endcocrine therapy helps reduce ...
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Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
Rochester, MN
This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.
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Study to Evaluate Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The primary goal of this study is to determine response rates (>=PR) of prospectively treated MM patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
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Combination Chemotherapy in Treating Women With Breast Cancer
No Locations
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
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Study to Evaluate CCS1477 in Haematological Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is primarily designed to evaluate the safety and tolerability of CCS1477 in patients with relapsed or refractory acute myeloid leukaemia (AML)/high-risk myelodysplastic syndrome (MDS), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL; B or T-cell).
CCS1477 is a potent, selective and orally bioavailable inhibitor of the bromodomain of p300 and CBP, critical transcriptional co-activators of genes that drive cell proliferation and survival. The compound causes G1 cell cycle arrest and is anti-proliferative across a broad range of haematological cell models, representative of AML, MM and lymphomas. This is also accompanied by an increase in myeloid differentiation in ...
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A Study of Pembrolizumab Alone as Therapy for Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to examine the effectiveness and safety of pembrolizumab as first line or above treatment in patients with metastatic triple-negative breast cancer.
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A Study to Evaluate the Use of Nivolumab and Pomalidomide Combination for Relapsed/Refractory Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone ...
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Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Rochester, MN
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
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Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Rochester, MN
Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.
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A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
Rochester, MN
This open-label, multicenter, global study is designed to determine the recommended phase 2 dose, safety, efficacy, and pharmacokinetics/pharmacodynamics of durvalumab in subjects with certain lymphoma subtypes or CLL. Globally, 265 subjects may be enrolled into 4 treatment arms, including durvalumab monotherapy; durvalumab in combination with lenalidomide± rituximab; ibrutinib; or rituximab ± bendamustine. The study will have 3 parts: dose finding, dose confirmation, and dose expansion. Subjects receiving monotherapy may receive combination therapy or involved-field radiation to a single nodal site at time of progressive disease.
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Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
Jacksonville, FL
Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D.
Part B: Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.
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A Study to Compare CMP-001 Combined with Nivolumab to Nivolumab Alone in Advanced Melanoma Subjects
Scottsdale/Phoenix, AZ
The purpose of this two-phase study is to compare CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.
The primary objective of Phase 2 is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The primary objective of Phase 3 is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.
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Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
Scottsdale/Phoenix, AZ; Rochester, MN
This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants ...
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A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (t rastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 wee ks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).
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Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Rochester, MN
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with enzalutamide may be a better treatment for patients with breast cancer.
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MEDI5395 Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose for this study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.
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Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Rochester, MN
The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.
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A Study to Explore the Effects of the Measles Virus on Tumor Immunity
Rochester, MN
The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.
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A Study to Continue A Long Term Follow-Up of Patients Given Doxorubicin-Cyclophosphamide Therapy for Breast Cancer
La Crosse, WI
The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer.
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A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors
Rochester, MN
The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).
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A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
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Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.
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A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...
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A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the response rate (ORR) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib, and to assess the progression free survival (PFS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
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Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Rochester, MN
The main purpose of this study is to compare the effectiveness of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
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A Study to Evaluate Pembrolizumab Combined with Intensive Chemotherapy to Treat Patients with Acute Myeloid Leukemia
Jacksonville, FL
The purpose of this study is to determine how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving induction chemotherapy with pembrolizumab may work ...
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Virtual Mindfulness and Weight Management Program in Patients with Cancer Histories
La Crosse, WI
The purpose of this study is to improve well-being and promote weight loss using a virtual mindfulness and activity promotion program among rural patients with a history of cancer.
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A Study to Test Adding Pembrolizumab to Olaparib Alone as Therapy for Patients with Pancreatic Cancer That Has Spread with Inherited BRCA Mutations
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
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Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
La Crosse, WI
The purpose of this research is to determine if previously adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone.
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Role Of Immunity In Efficacy Of Chemotherapy Plus Trastuzumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate T cell and antibody immunity in patients with HER2+ breast cancer who will receive trastuzumab with standard chemotherapy in order to address whether the immunity is associated with the patient’s response to treatment.
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Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Jacksonville, FL; Rochester, MN
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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LEGEND Study: A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of intravesical administration of EG-70 and in the bladder and its effect on bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC).
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Genetics of Chemotherapy-Related Amenorrhea in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to assess genetic predictors of chemotherapy-related amenorrhea in breast cancer survivors of both European and non-European ancestry.
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A Study to Evaluate PDS0101 and Pembrolizumab Combination to Treat Subjects with HPV16 + Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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A Study to Test Nivolumab with Usual Chemotherapy Treatment or Usual Chemotherapy Treatment Alone to Treat Recurrent or Metastatic Nasopharyngeal Cancer
Jacksonville, FL
The purpose of this study is to compare the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus the usual chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by ...
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A Study to Assess Dendritic Cell Immunotherapy Plus Standard-of-Care to Treat Advanced Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate CMN-001 in a randomized trial between standard-of-care (SOC) (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-001.
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Phase 1 Study of Oral TP-1454
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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NL-201 in Patients With Relapsed or Refractory Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.
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A Study to Evaluate DS-1062a Combined with Pembrolizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
Scottsdale/Phoenix, AZ; Rochester, MN; Rochester, MN
In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as ...
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A Study to Evaluate Pembrolizumab, Ixazomib Citrate, and Dexamethasone to Treat Participants with Relapsed Multiple Myeloma
Rochester, MN
This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating participants with multiple myeloma that has come back. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together ...
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I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more cancer cells.
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A Study of Chemotherapy-induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to collect clinical and biomarker data from patients receiving neurotoxic chemotherapy who are at risk for developing Chemotherapy-induced Peripheral Neuropathy (CIPN).
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Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
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M6620 First in Human Study
Scottsdale/Phoenix, AZ; Rochester, MN
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors
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A Study to Evaluate Pemetrexed and Pembrolizumab to Treat Recurrent and/or Metastatic Salivary Gland Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).
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Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Rochester, MN
RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.
PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
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A Study of ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness, safety, biological activity, and drug/body interactions of ACP-196 alone and combined with Pembrolizumab for the treatment of patients who have advanced or metastatic pancreatic cancer.
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A Phase 2 Study of Anti-PD-L1 Antibody Atezolizumab in Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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A Study to Evaluate Gemcitabine and MK-3475 (Pembrolizumab) to Treat Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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Immune Predictors of Response to Pembrolizumab Therapy in Stage IV Melanoma Patients
Rochester, MN
This study will test whether immune functions in individual cancer patients can be characterized in a quantitative manner using new technologies that analyze nucleic acids from peripheral blood cells and whether those quantitations can be used to predict the response outcomes of patients being treated with Pembrolizumab.
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A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Rochester, MN
The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
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A Study of Pembrolizumab Alone or Combined with CC-486 for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer
Rochester, MN
The purpose of the study is to determine the best dose of CC-486 (oral azacitidine) combined with pembrolizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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A Study to Evaluate Pembrolizumab for Surgically Treated Adjuvant Merkel Cell Carcinoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; La Crosse, WI; Eau Claire, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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A Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
Scottsdale/Phoenix, AZ
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
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Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective multicenter single-arm observational study
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.
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Patient Self-sampling of HPV to Screen for Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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An Early Access Program (EAP) for Avapritinib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this expanded access program is to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
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A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)
Rochester, MN
This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.
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Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
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A Study to Evaluate Abemaciclib to Treat Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration
Jacksonville, FL
The purpose of this study is to evaluate the 12-week progression free survival (PFS) rate in treated subjects, based on historical sarcoma trial outcomes (PFS at 12 weeks ≤ 20% will be considered a negative outcome, and 12- week PFS rate of 40% or more will be considered positive).
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A Study of Microvasculature Imaging of Breast Masses
Rochester, MN
The overall goal is to investigate the value of ultrasound imaging of small vasculature as a new biomarker for cancer characterization and early treatment evaluation.
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A Study to Evaluate Binimetinib in Combination with Encorafenib in Patients with Pancreatic Malignancies and a Somatic BRAFV600E Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.
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A Study to Evaluate Larotrectinib to Treat Patients with Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia
Rochester, MN
The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Jacksonville, FL; Rochester, MN
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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LEGEND Study: A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of intravesical administration of EG-70 and in the bladder and its effect on bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC).
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Genetics of Chemotherapy-Related Amenorrhea in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to assess genetic predictors of chemotherapy-related amenorrhea in breast cancer survivors of both European and non-European ancestry.
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A Study to Evaluate PDS0101 and Pembrolizumab Combination to Treat Subjects with HPV16 + Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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A Study to Test Nivolumab with Usual Chemotherapy Treatment or Usual Chemotherapy Treatment Alone to Treat Recurrent or Metastatic Nasopharyngeal Cancer
Jacksonville, FL
The purpose of this study is to compare the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus the usual chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by ...
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A Study to Assess Dendritic Cell Immunotherapy Plus Standard-of-Care to Treat Advanced Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate CMN-001 in a randomized trial between standard-of-care (SOC) (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-001.
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Phase 1 Study of Oral TP-1454
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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NL-201 in Patients With Relapsed or Refractory Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.
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A Study to Evaluate DS-1062a Combined with Pembrolizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more cancer cells.
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A Study of Chemotherapy-induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to collect clinical and biomarker data from patients receiving neurotoxic chemotherapy who are at risk for developing Chemotherapy-induced Peripheral Neuropathy (CIPN).
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Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
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M6620 First in Human Study
Scottsdale/Phoenix, AZ; Rochester, MN
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors
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A Study to Evaluate Pemetrexed and Pembrolizumab to Treat Recurrent and/or Metastatic Salivary Gland Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).
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Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Rochester, MN
RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.
PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
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A Study of ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness, safety, biological activity, and drug/body interactions of ACP-196 alone and combined with Pembrolizumab for the treatment of patients who have advanced or metastatic pancreatic cancer.
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A Phase 2 Study of Anti-PD-L1 Antibody Atezolizumab in Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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A Study to Evaluate Gemcitabine and MK-3475 (Pembrolizumab) to Treat Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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Immune Predictors of Response to Pembrolizumab Therapy in Stage IV Melanoma Patients
Rochester, MN
This study will test whether immune functions in individual cancer patients can be characterized in a quantitative manner using new technologies that analyze nucleic acids from peripheral blood cells and whether those quantitations can be used to predict the response outcomes of patients being treated with Pembrolizumab.
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A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Rochester, MN
The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
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A Study of Pembrolizumab Alone or Combined with CC-486 for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer
Rochester, MN
The purpose of the study is to determine the best dose of CC-486 (oral azacitidine) combined with pembrolizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.
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Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
Scottsdale/Phoenix, AZ; Rochester, MN; Rochester, MN
In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as ...
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A Study to Evaluate Pembrolizumab, Ixazomib Citrate, and Dexamethasone to Treat Participants with Relapsed Multiple Myeloma
Rochester, MN
This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating participants with multiple myeloma that has come back. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together ...
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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A Study to Evaluate Pembrolizumab for Surgically Treated Adjuvant Merkel Cell Carcinoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; La Crosse, WI; Eau Claire, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
Rochester, MN
The main purpose of the study is to evaluate safety and effectiveness of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
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Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib
Rochester, MN
The study purpose is to test the hypothesis that patients with Chronic phase-Chronic Myeloid Leukemia (CP-CML) with BCR-ABL transcript level > 10% International Standard (IS) after 3 months of treatment with first line Imatinib 400mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100mg once daily (QD) compared with continued treatment with Imatinib at any dose.
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Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test the safety of radiation therapy given at increased doses in a shorter period of time in order to find out what effects, good and/or bad, it has on the patient and the lung cancer. The standard way of giving the radiation therapy is to give it once daily for 6 to 7 weeks. The study is currently testing if a higher amount of radiation therapy per treatment can be given as well as shorten the total number of treatments to 4 or 5 weeks. The goal is that a higher dose of ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone
Rochester, MN
This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for ...
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Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2
Rochester, MN
The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.
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JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.
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First In Human Study Of TORL-1-23 In Participants With Advanced Cancer
Rochester, MN
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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Combination Study of SV-BR-1-GM in Combination With INCMGA00012 and Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
Jacksonville, FL; Rochester, MN
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer ...
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A Dose Escalation Study of HFB301001 in Adult Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).
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Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms
Rochester, MN
The purpose of this study is to analyze the impact of active participation of patients in producing tones in combination with breathing technique; i.e., TBT to reduce aromatase inhibitor induced musculoskeletal symptoms.
Tonation Breathing Techniques (TBT) is a set of diverse, mostly non-strenuous, specialized breathing techniques with the addition of Tonation; i.e., controlled exhalation through nostrils or lips while producing and sustaining a constant sound frequency as is comfortable to the participant as instructed in Musopathy sessions and/or videos.
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A Study of the Use of Molecular Breast Imaging to Evaluate Breast Cancer Tumor Response to Therapy that is Newly Supplemental to Standard Treatment
Rochester, MN
The purpose of this study is to evaluate the use of molecular breast imaging as an accurate way to assess the response of breast cancer tumors to chemotherapy or hormone therapy that is newly supplemental to the standard treatment.
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A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.
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Perfusion MRI for Therapy Response Assessment in Brain Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to improve patient care by optimizing and measuring magnetic resonance imaging methods for the early detection of brain cancer response to therapy.
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Radiation Therapy, Paclitaxel, and Carboplatin with or without Trastuzumab in Treating Patients with Esophageal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to ...
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Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Rochester, MN
This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
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A Study to Evaluate Ablation in Patients with A Soft-Tissue Liver Lesion
Rochester, MN
The purpose of this study is to evaluate the use of the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
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A Study of the Safety and Effectiveness of Combined Toca 511 and Toca FC for Patients Having Removal Surgery for Recurring Glioblastoma or Anaaplastic Astrocytoma
Jacksonville, FL
The purpose of this study is to assess the safety and effectiveness of combined Toca 511 and Toca FC, versus a standard of care single agent chemotherapy, for patients who are having surgery to remove a first or second recurrence of glioblastoma or anaplastic astrocytoma.
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Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells ...
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Pemigatinib to Treat Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
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A Study to Establish a Platform for Managing Pancreatic Adenocarcinoma Using Patient-derived Tumoroids
Jacksonville, FL
The purposes of this study are to determine the optimal patient-derived tumoroid (PDT) model, to determine the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach, to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish PDT as a platform for a personalized approach to guide multimodality treatment.
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A Study to Evaluate Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment for Stage I-IIIA Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to determine how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery ...
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A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Rochester, MN
This phase 1b trial is an open-label study designed to assess the safety, tolerability, and preliminary antitumor activity of REGN5458 in combination with other cancer treatments for patients with relapsed/refractory multiple myeloma (RRMM).
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A Study Using Targeted Inhibitors to Treat Specific Tumor Mutations in Patients with Meningiomas
Jacksonville, FL; Rochester, MN
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies
Rochester, MN
This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (BelieveIT-201)
Rochester, MN
The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.
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A Study Using Avelumab in Non-Small Cell Lung Cancer that has Progressed
Scottsdale/Phoenix, AZ
The purpose of this study is to demonstrate avelumab's overall survival superiority versus docetaxel in patients with programmed death ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) after the failure of a platinum-based doublet.
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Study of Cabozantinib Combined With Atezolizumab Vs. Second Novel Hormonal Therapy in Subjects with Metastatic Castration-Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
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A Study to Evaluate Durvalumab plus Topotecan or Lurbinectedin in Patients with Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate whether the combination of durvalumab plus lurbinectedin can increase 6 month progression-free survival, in patients with extensive stage small cell lung cancer who have progressed after treatment with an initial combination of chemotherapy and immunotherapy.
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Intrapleural Measles Virus Therapy in Patients with Malignant Pleural Mesothelioma
Rochester, MN
This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells.
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A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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A Phase I Study of MSB2311 in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.
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Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia
Rochester, MN; Albert Lea, MN; Mankato, MN
The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment. This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.
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Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. I
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Acetylsalicylic Acid in Preventing Disease Recurrence in Patients With Barrett's Esophagus After Successful Elimination by Radiofrequency Ablation
Rochester, MN
This randomized phase II trial studies the safety of and how well acetylsalicylic acid (Aspirin) works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether acetylsalicylic acid can prevent it from returning after it has been successfully treated.
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A Phase 1/2 Study to Evaluate MEDI4736
Jacksonville, FL
This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors. An exploration cohort has been added to determine the safety using Q4W dosing.
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A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies
Rochester, MN
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.
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Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.
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A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
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A Study of Women undergoing Mammogram Screening at Mountain Park Clinic
Scottsdale/Phoenix, AZ; Rochester, MN
The goal of this research is to identify risk profiles of women (with particular emphasis on Hispanic women) for breast cancer based on family history, breast density and other factors known to impact risk such as age, weight, age at menarche, age at birth of first child, etc.
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A Study to Evaluate the Safety and Effectiveness of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after Aromatase Inhibitor (AI) therapy.
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A Study of Tamoxifen Citrate for Treating Patients with Metastatic or Recurrent Breast Cancer
Rochester, MN
The purpose of this studyis to assess how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.
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Pembrolizumab With Chemotherapy and With/Without MK-4830 for Treating Participants With Ovarian Cancer
Jacksonville, FL
The purpose of this study is to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + Standard of Care (SOC) therapy.
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A Study to Evaluate Cemiplimab Survivorship Epidemiology
Jacksonville, FL
The primary purpose of this study is to identify potential determinants of disease progression, Quality of Life (QOL), and other health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab. In addition, the study will aim to assess patient experience, including QOL and functional status, to identify and describe long-term effects of treatment of patients with CSCC, to collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants, to describe patients who receive cemiplimab as treatment for CSCC in a real-world setting, to describe real-world use patterns of cemiplimab for CSCC, to assess the long-term ...
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S1211, Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together ...
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Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
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A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to define the recommended dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent Non-Hodgkin's Lymphoma (NHL).
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A Study of Atezolizumab Alone or Combined with Immunomodulatory Drug and/or Daratumumab in Multiple Myeloma Patients
Jacksonville, FL
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.
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Lung Nodule Management And Lung Cancer Screening In Patients With Abnormal Ct-Scan
Jacksonville, FL
The purpose of this study is to assess the current rate of adherence to incidental lung nodule management and lung cancer screening guidelines in at-risk lung cancer patients identified from chart review.
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A Study to Test the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
Rochester, MN
The purpose of this study is to determine how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs ...
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Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
Jacksonville, FL
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Jacksonville, FL
This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.
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Perfusion MRI for Therapy Response Assessment in Brain Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to improve patient care by optimizing and measuring magnetic resonance imaging methods for the early detection of brain cancer response to therapy.
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Radiation Therapy, Paclitaxel, and Carboplatin with or without Trastuzumab in Treating Patients with Esophageal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to ...
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Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Rochester, MN
This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
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A Study to Evaluate Ablation in Patients with A Soft-Tissue Liver Lesion
Rochester, MN
The purpose of this study is to evaluate the use of the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
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A Study of the Safety and Effectiveness of Combined Toca 511 and Toca FC for Patients Having Removal Surgery for Recurring Glioblastoma or Anaaplastic Astrocytoma
Jacksonville, FL
The purpose of this study is to assess the safety and effectiveness of combined Toca 511 and Toca FC, versus a standard of care single agent chemotherapy, for patients who are having surgery to remove a first or second recurrence of glioblastoma or anaplastic astrocytoma.
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Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells ...
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Pemigatinib to Treat Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
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A Study to Establish a Platform for Managing Pancreatic Adenocarcinoma Using Patient-derived Tumoroids
Jacksonville, FL
The purposes of this study are to determine the optimal patient-derived tumoroid (PDT) model, to determine the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach, to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish PDT as a platform for a personalized approach to guide multimodality treatment.
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A Study to Evaluate Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment for Stage I-IIIA Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to determine how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery ...
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A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Rochester, MN
This phase 1b trial is an open-label study designed to assess the safety, tolerability, and preliminary antitumor activity of REGN5458 in combination with other cancer treatments for patients with relapsed/refractory multiple myeloma (RRMM).
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A Study Using Targeted Inhibitors to Treat Specific Tumor Mutations in Patients with Meningiomas
Jacksonville, FL; Rochester, MN
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies
Rochester, MN
This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
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A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (SunRISe-3)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
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A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
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Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants with Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
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Combination Vaccine Immunotherapy (DRibbles) for Patients with Definitively-treated Stage III Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune response against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.
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Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Rochester, MN
This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. Giving ipilimumab or nivolumab or both with ...
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A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) (Morpheus-Gastric Cancer)
Scottsdale/Phoenix, AZ; Rochester, MN
A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer). Two cohorts will be enrolled in parallel in this study: the second-line (2L) Cohort will consist of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Cohort will consist of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible ...
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Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to compare the usual treatment alone to using immunotherapy (atezolizumab) plus the usual treatment in treating patients with peritoneal mesothelioma. The usual treatment consists of surgery or chemotherapy. Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the ...
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Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy
Rochester, MN
The purpose of this study is to gain stepwise understanding of the fundamental biology governing human antitumor immunity, by systematic study of the tumor-immune interface at the level of the TME, taking advantage of the heterogeneity of different interacting tumor and immune cell subsets.
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A Study to Evaluate a New Anti-Cancer Vaccine for Patients with Non-Small Cell Lung Cancer, Given After Tumor Removal by Surgery
Rochester, MN
The purpose of this clinical study is to assess the safety and effectiveness of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.
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A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)
Albert Lea, MN; Mankato, MN
This study is being conducted to see if adding Exemestane to the immune checkpoint blockade can slow disease progression in post-menopausal women with non-small cell lung cancer.
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A Study Assessing the Effectiveness and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced Triple Negative Breast Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)
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A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat when given in combination with pembrolizumab and chemotherapy. Once the recommended doses have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.
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A Study to Evaluate Prevention of Paclitaxel-Associated Neuropathy with Fingolimod
Rochester, MN
The purpose of this study is to determine if the use of Gilenya® can reduce neuropathy caused by paclitaxel.
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A Study to Evaluate Estrogen Receptor (ER) Reactivation Therapy for Breast Cancer
Rochester, MN
The purpose of this study is to evaluate whether or not treatment with alternating 17B-estradiol / anti-estrogen therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth than continuous treatment with either type of therapy in patients with metastatic anti-estrogen-resistant ER+ breast cancer.
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A Study to Evaluate TG4050 in Ovarian Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability, as well as some activity parameters, of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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A Study of Mogamulizumab Combined with Nivolumab in Patients who have Locally Advanced or Metastatic Solid Tumors
Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of combined treatment with mogamulizumab and nivolumab, and also determine the maximum tolerated dose and the recommended fixed dose for the treatment of patients who have locally advanced or metastatic solid tumors.
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A Study to Analyze CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
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A Study of MPDL3280A (Anti-PD-L1 Antibody) Combined with Carboplatin and Paclitaxel , and with or without Bevacizumab, for Patients who have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of a treatment of Atezolizumab (MPDL3280A) combined with carboplatin, paclitaxel, and with or without bevacizumab, versus carboplatin, paclitaxel and bevacizumab in patients with stage IV non-squamous non-small cell lung cancer who have never had chemo therapy.
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SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
Rochester, MN
The primary objective of this study is to determine the safety profile of SX-682 alone and in combination with pembrolizumab in subjects with metastatic melanoma, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT).
The secondary objectives are to evaluate the efficacy of SX-682 in combination with pembrolizumab on the basis of the objective response rate, the duration of response, and the rate of progression, and to characterize the single-dose and multidose pharmacokinetic (PK) profile of SX-682.
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Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Rochester, MN
The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.
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A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors
Rochester, MN
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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A Study to Evaluate Immunotherapy for Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Jacksonville, FL; Rochester, MN
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Study to Evaluate Chemotherapy-Induced Nausea in Breast Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN; Albert Lea, MN; Mankato, MN
The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.
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Niraparib + TSR042 In BRCA Mutated Breast Cancer
Rochester, MN
The purpose of this study is to evaluate pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA mutations. The drugs are Niraparib (Zejula) and Dostarlimab.
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A Study To Better Understand How To Predict And Manage Patients Who Are At High Risk For Developing Rheumatic Immune-related Adverse Events While Receiving Treatment For Melanoma
Rochester, MN
The purpose of this study is to:
- Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
- Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
- Establish a repository of biological samples from patients with irAE and corresponding rheumatologic
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TheraSphere With and Without Durvalumab and Tremelimumab for HCC
Jacksonville, FL
The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Breast Cancer: Can We Predict Pathological Complete Response following Neoadjuvant Treatment?
Scottsdale/Phoenix, AZ
This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).
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School Employees Breast Cancer Risk Due to Environmental Exposures
Rochester, MN
The purpose of this study is to conduct exploratory comparisons of 1) the environmental exposures of the cases and controls through numerous methodologies including metal analysis, metabolomics, and exposomics. Samples collected will include hair, nails, blood, and urine.
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Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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A Study to Evaluate the Use of Organoids to Advance Precision Medicine in Bladder Cancer
Rochester, MN
The purpose of this study is to develop patient-derived organoid cultures of urothelial carcinoma from non-invasively obtained urine samples and to characterize the histological, molecular and functional features of patient-derived organoids.
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ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer
Rochester, MN
This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe). Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever ...
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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A Safety Study of SGN-LIV1A in Breast Cancer Patients
Rochester, MN
This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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Elevate CLL R/R: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.
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Specialty Compared to Oncology Delivered Palliative Care for Treating Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to evaluate whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer, the ENHANCE Study
Rochester, MN
The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
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A Study to Evaluate the Use of Organoids to Advance Precision Medicine in Bladder Cancer
Rochester, MN
The purpose of this study is to develop patient-derived organoid cultures of urothelial carcinoma from non-invasively obtained urine samples and to characterize the histological, molecular and functional features of patient-derived organoids.
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ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer
Rochester, MN
This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe). Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever ...
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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A Safety Study of SGN-LIV1A in Breast Cancer Patients
Rochester, MN
This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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A Study of Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia, or Refractory or Relapsed Acute Myelogenous Leukemia
Rochester, MN
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening.
PURPOSE: Natural Killer (NK) ...
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Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations
Rochester, MN
The purpose of this study is to evaluate how well veliparib, radiation therapy, and temozolomide work in treating participants with newly diagnosed malignant glioma without H3 K27M or BRAFV600E mutations. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide ...
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A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
Jacksonville, FL
The purpose of this study is to test the safety and effectives of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
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A Study to Evaluate CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work ...
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
Rochester, MN
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can ...
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Semen Analysis In Chemotherapy
Rochester, MN
The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Breast Cancer: Can We Predict Pathological Complete Response following Neoadjuvant Treatment?
Scottsdale/Phoenix, AZ
This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).
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School Employees Breast Cancer Risk Due to Environmental Exposures
Rochester, MN
The purpose of this study is to conduct exploratory comparisons of 1) the environmental exposures of the cases and controls through numerous methodologies including metal analysis, metabolomics, and exposomics. Samples collected will include hair, nails, blood, and urine.
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A Study to Evaluate the Efficacy of a Hybrid Imaging and Measurement Tool for Breast Cancer Detection and Monitoring
Rochester, MN
The purpose of this research is to optimize and evaluate the efficacy of a hybrid imaging and quantitative viscoelasticity measurement tool for breast cancer detection and monitoring.
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Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole may stop the growth of tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).
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Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial has several primary objectives. One primary objective is to compare the efficacy of 3 different endocrine therapies, the estrogen receptor down regulator fulvestrant and the aromatase inhibitor anastrozole, either alone or in combination, in reducing cancer growth before surgery (neoadjuvant) in postmenopausal women with clinical stage II-III estrogen receptor positive and HER2 negative breast cancer. Another primary objective is to evaluate whether patients who achieved a modified PEPI (Preoperative Endocrine Prognostic Index) score of 0, defined by tumor size <5 cm,="" n0,="">5><2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy ... (by="" central="" testing),="" at="" surgery="" post="" 6="" months="" of="" neoadjuvant="" endocrine="" therapy="" ...="">2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy ... >
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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
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Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment ...
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A Study to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
Rochester, MN; Jacksonville, FL
To evaluate the effectiveness of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors.
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Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or ...
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A Study to Evaluate Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
Rochester, MN
The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.
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Testing Nivolumab and Ipilimumab With Short-Course Radiation in Advanced Rectal Cancer
Rochester, MN
The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
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A Study to Test the Addition of berzosertib to Usual Radiation Treatment for Chemotherapy-Resistant Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the recommended Phase 2 dose twice weekly of berzosertib administered concurrently with conventionally fractionated radiation therapy to the breast/chest wall and regional nodes.
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Inotuzumab Ozogamicin In Treating Younger Patients With Relapsed Or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
Rochester, MN
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
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Abiraterone/Prednisone, Olaparib, Or Abiraterone/Prednisone + Olaparib In Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Rochester, MN
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.
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Study Comparing Thin Dressings To Prevent Skin Inflammation In Breast Cancer Patients
Rochester, MN
We are doing this research study to compare radiation dermatitis severity in exposed skin protected by a thin film dressing versus skin that is not protected during radiation treatment. We will also be comparing two types of film; a perforated thin film dressing versus the standard thin film.
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De-Escalation Of Breast Radiation Trial For Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than Or Equal To 18 Breast Cancer (DEBRA)
Albert Lea, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
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Evaluation of Sensibility with Targeted Nipple Areola Complex Re-innervation in Nipple Sparing Mastectomy
Scottsdale/Phoenix, AZ
To determine the effectiveness of targeted nipple areola complex (NAC) re-innervation for improving sensibility in women undergoing nipple sparing mastectomy (NSM).
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Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Rochester, MN; Scottsdale/Phoenix, AZ
To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.
a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
c. ...
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A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Rochester, MN
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
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Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors
Rochester, MN
This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.
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A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma
Rochester, MN
The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.
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A Study to Evaluate Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
La Crosse, WI
The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area in patients with prostate cancer to find out which is better.
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Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer
Rochester, MN
This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
La Crosse, WI
This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy ...
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Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
Rochester, MN
This partially randomized phase III trial studies isotretinoin with monoclonal antibody Ch14.18, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to ...
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Durvalumab and Grid Therapy for the Treatment of Non-small Cell Lung Cancer in Patients Who Progressed During or After Treatment With the PACIFIC Regimen
Rochester, MN
The purpose of this study is to determine whether combining grid therapy at the time of disease progression during durvalumab administration or shortly after durvalumab discontinuation may permit patients to continue on durvalumab which was otherwise effective at preventing polymetastatic disease.
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Safety and Efficacy of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells in Subjects with Relapsed or Refractory BAFFR-expressing B-cell Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of escalating doses of MC10029 following lymphodepleting (LD) therapy in subjects with relapsed or refractory BAFFR-expressing B-cell hematologic malignancies to determine the recommended dose for phase 1b (dose expansion).
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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
Rochester, MN
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...
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A Study to Understand Symptoms from Olaparib
Rochester, MN
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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A Study of Caring Hand Massage for Cancer Patients Undergoing Chemotherapy in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.
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Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
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Adipose-Derived Mesenchymal Stem Cells (AMSCs) For Recurrent Glioblastoma
Jacksonville, FL
This study aims to evaluate the safety of local delivery of AMSCs for recurrent GBM by noting the incidence of adverse events, as well as radiological and clinical progression.
To assess the preliminary efficacy of local delivery of AMSCs for recurrent GBM by comparing the clinical, survival, progression, and radiographic outcomes from patients enrolled in our study to historical controls from our institution.
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Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
Rochester, MN
The purpose of this study is to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used to assess radiographic response at the end of treatment. Each subject's treatment assignment will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years.
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A Study to Evaluate the Combination of Margetuximab, Retifanlimab, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the effectiveness of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging and Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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De-Escalated Adjuvant And Definitive Radiation Therapy Informed By DART 2.0 CtHPV-DNA
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary goal of this study is to prospectively incorporate ctHPVDNA in combination with clinical and pathologic factors to appropriately select patients for treatment intensity.
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Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
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Study Comparing CB-839 with Cabozantinib vs. Cabozantinib with Placebo in Patients with Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.
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Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
Rochester, MN
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop ...
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A Study to Evaluate the Safety of HANAROSTENT® Biliary Flap Lasso Stent System Use to Treat Cancer Patients with Biliary Obstruction
Rochester, MN
The purpose of this study is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.
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Remote Intervention for Strength Training in Endometrial Cancer
Rochester, MN
The purpose of this study is to positively impact endometrial cancer (EC) survivorship through a fully remote home-based exercise program. We believe this type of survivorship care will be accessible, sustainable, and scalable. We seek to design and implement a telehealth strength-based exercise intervention in rural EC survivors, a group currently overlooked in most survivorship studies.
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A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer (CAPTAIN)
Rochester, MN; Jacksonville, FL
The primary objective of this study is to compare the safety and effectiveness for the TULSA Procedure versus radical prostatectomy in treating men with localized intermediate-risk prostate cancer.
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Amino Acid Pet For Brain Tumors
Rochester, MN
The purpose of this study is to utilize amino acid PET such as 18F-DOPA PET/CT for use in brain tumor patients.
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Sirolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients At High Risk for Cholangiocarcinoma Recurrence After Liver Transplant or Surgery
Rochester, MN
This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with gemcitabine hydrochloride and cisplatin may be an effective treatment for patients with a high ...
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Ruxolitinib Prior to Transplant in Patients With Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate whether adding the drug Ruxolitinib will further aid in reducing pre-transplant ...
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A Study to Assess Multiparametric MR Elastography (MRE) in Diagnosing and Monitoring Cirrhosis or Hepatocellular Carcinoma (HCC) Patients
Rochester, MN
The primary purpose of this study is to is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for early identification of hepatocellular carcinoma (HCC) involvement, differentiation, and risks of microvascular invasion.
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Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Jacksonville, FL; Rochester, MN
This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others ...
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(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
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Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic
Rochester, MN
This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.
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Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known ...
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Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.
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Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Rochester, MN
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. ...
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A Study to Evaluate Wound Infiltration with Liposomal Bupivacaine in Laparotomy for Gynecological Malignancy
Rochester, MN
The purpose of this study is to determine whether or not there is a benefit to adding opioid injection around the spinal cord ( intrathecal) to incisional long-acting local anesthetic (liposomal bupivacaine) injection for pain management after abdominal surgery for gynecological cancer.
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A Study to Evaluate Encorafenib Plus Cetuximab with/without Chemotherapy to Treat Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
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Phase II Trial of Standard Chemotherapy +Various Proton Beam Therapy (PBT) Doses for Unresectable Stage 2/3 Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study is being done to study which dose of proton beam therapy (PBT) for unresectable stage 2/3 Non-Small Cell Lung Cancer.
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Ultrasound-guided Tissue Acquisition Of Hepatic Draining Lymph Nodes In The Evaluation Of Unresectable Perihilar Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to test the feasibility of NanoString digital spatial profiling (DSP) and RNAscope™ on prospectively acquired HDLN tissue samples with EUS-FNB in patients with unresectable perihilar CCA undergoing liver transplant (LT) evaluation.
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Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
Jacksonville, FL
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
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A Study to Assess a Multicenter Cancer Biospecimen Collection
Rochester, MN
This is a retrospective specimen acquisition study of pre-treatment head and neck squamous cell carcinoma tumor biopsy samples. The sponsor-provided protocol allows for multiple different tumor types. However, Mayo Clinic, Rochester will only enroll head and neck squamous cell carcinoma.
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A Phase 1b/2 Safety and Tolerability of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Scottsdale/Phoenix, AZ
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL. MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.
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Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) with Avelumab in Muscle Invasive Bladder Cancer
No Locations
The purpose of this study is to evaluate the complete response rate of concurrent chemotherapy radiation treatment combined with avelumab for patients with muscle invasive bladder cancer.
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Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Jacksonville, FL
The purpose of this study is to evaluate the timing of AVB-620 administration relative to surgery on the fluorescence and accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues in women undergoing surgery with primary, nonrecurrent and nonmetastatic breast cancer.
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Cabozantinib and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how well cabozantinib and nivolumab work in treating patients with endometrial cancer that has come back or spread to other places in the body.
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A Study to Evaluate Tazemetostat and Pembrolizumab to Treat Advanced Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary purpose of this study is to conduct a safety lead-in phase that identifies the safe recommended phase II dose for combination tazemetostat and MK-3475 (pembrolizumab) in patients with advanced urothelial carcinoma.
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Obtain Fresh Glioblastoma Tissue to Analyze Cell Count and Viability in Developing IGV-001
Jacksonville, FL
The purpose of this study is to utilize fresh tumor tissue to aid the development of future therapies for brain cancer.
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Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
Scottsdale/Phoenix, AZ; La Crosse, WI
The purpose of this phase II/III trial is to compare the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely ...
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Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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A Study to Examine Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Jacksonville, FL
The purpose of this study is to examine how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
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A Study to Evaluate the Safety of Lasofoxifene in Combination with Abemaciclib in Advanced or Metastatic ER+/HER2− Breast Cancer with ESR1 Mutation
Jacksonville, FL; Rochester, MN
The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
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A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Rochester, MN; Jacksonville, FL
The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
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FT516 in Subjects With Advanced Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
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A Study To Evaluate Treatment Of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, MN
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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TRPC6 To Predict And Prevent Chemotherapy Related Cardiomyopathy And Heart Failure (Prospective Study)
Jacksonville, FL
The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.
Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years)
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A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with GRPR+, ER+, HER2- metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibito
Rochester, MN
The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).
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Lenalidomide And Dexamethasone With Or Without Bortezomib In Treating Patients With Previously Untreated Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...
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An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Rochester, MN
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
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Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities in Patients with Known or Suspected Breast Cancer
Rochester, MN
The purpose of this study is to confirm that the Stereo Navigator accessory to an MBI Imging system can successfully guide the sampling of abnormal MBI findings in patients with known or suspected breast cancer.
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Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer
Rochester, MN
We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.
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A Study To Evaluate The Safety And Efficacy Of Mesothelin-Targeting Logic-gated CAR T, In Participants With Solid Tumors That Express MSLN And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment ...
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Study Of The Bria-IMT Regimen And CPI Vs Physicians' Choice In Advanced Metastatic Breast Cancer. (BRIA-ABC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
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A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression ...
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NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
Jacksonville, FL
The primary purpose of this study is to assess the safety and tolerability of NKX101 including dose-limiting toxicities (DLTs), and to identify the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of NKX101.
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Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurrent or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Goal: To determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing multiple myeloma.
The rationale for using MUC1-stimulated T-cells to treat multiple myeloma is twofold. The first is that T-cell therapies have been shown to be active in myeloma, making it an attractive disease model for the proposed study. The other is that we are expanding and using naturally occurring myeloma-fighting T-cells which may offer benefits, particularly with respect to longevity, as compared to the methods currently being employed using CAR-T and bispecific antibodies. This is highly significant as one of the ...
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Improving Management of Breast Biopsy With Genetic Testing
Jacksonville, FL
The purpose of this study is to collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) and related single-nucleotide polymorphisms (SNPs) to final diagnosis of DCIS, invasive breast cancer or BBD; BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise. Also, to relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries. Additionally, to relate PRS (and related SNPs) to molecular markers in pathologic lesions and background ...
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Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: ...
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Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.
PURPOSE: ...
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Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
Scottsdale/Phoenix, AZ
This randomized clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. After the surgery, patients are randomized to receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
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Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Rochester, MN
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells ...
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A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if Regorafenib improves overall survival in refractory AGEC A randomized phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo) randomization and stratification by:
- Location of tumor (GEJ vs. gastric);
- Geographic region (Asia vs. Rest of World);
- Prior VEGF inhibitors (Yes vs No).
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Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Rochester, MN
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
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A Study to Evaluate Trifluridine/Tipiracil Combined with Bevacizumab vs Trifluridine/Tipiracil to Treat Patients with Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer (mCRC).
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Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer. The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will ...
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A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Rochester, MN
This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
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ZTE MRI For Visualization Of Bone Cement, Breast Biopsy Markers
Rochester, MN
The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
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Acceptance and Commitment Therapy Compassion-Based Virtual Group Intervention for Diverse Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the impact of an Acceptance and Commitment Therapy and Compassion-Based virtual group intervention for diverse cancer patients at Mayo Clinic in Arizona.
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Optical Fusion Trans-Perineal Grid
Rochester, MN
The purpose of this study is to evaluate and assess a new perineal access tool to enable image guided prostate interventions by Clear Guide Medical in collaboration with the Mayo Clinic.
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cfDNA with Natera
Rochester, MN
The purpose of this study is to collect blood and tumor tissue from esophageal cancer patients in order to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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A Study to Compare Cabozantinib versus Sunitinib to Treat Metastatic Variant Histology Renal Cell Carcinoma Patients
Rochester, MN
The purpose of this investigational study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.
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Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients with Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells.
PURPOSE: This phase I trial studies the side effects and ...
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Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.
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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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WISP (Women Choosing Surgical Prevention)
Rochester, MN
This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.
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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
No Locations
Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
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COlorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑Controlled Phase-III STudy
Rochester, MN
To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy
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Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy
Rochester, MN
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma.
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A Study to Evaluate Triapine Combined with Lutetium Lu 177 Dotatate for Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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A Study to Compare ACP-196 and Obinutuzumab with Chlorambucil, or ACP-19 alone, with Obinutuzumab and Chlorambucil, for Patients with Previously Untreated Chronic Lymphocytic Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of ACP-196 combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).
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Improving Treatment Planning suing LiDAR Surface Mapping of Radiotherapy Patients
Jacksonville, FL
The purpose of this study is to show the feasibility of using the LiDAR scanner to supplement the radiation treatment simulation CT scan.
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) In Patients With Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This randomized phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the ...
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A Study to Assess a Multicenter Cancer Biospecimen Collection
Rochester, MN
This is a retrospective specimen acquisition study of pre-treatment head and neck squamous cell carcinoma tumor biopsy samples. The sponsor-provided protocol allows for multiple different tumor types. However, Mayo Clinic, Rochester will only enroll head and neck squamous cell carcinoma.
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A Phase 1b/2 Safety and Tolerability of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Scottsdale/Phoenix, AZ
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL. MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.
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Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) with Avelumab in Muscle Invasive Bladder Cancer
No Locations
The purpose of this study is to evaluate the complete response rate of concurrent chemotherapy radiation treatment combined with avelumab for patients with muscle invasive bladder cancer.
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Obtain Fresh Glioblastoma Tissue to Analyze Cell Count and Viability in Developing IGV-001
Jacksonville, FL
The purpose of this study is to utilize fresh tumor tissue to aid the development of future therapies for brain cancer.
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Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
Scottsdale/Phoenix, AZ; La Crosse, WI
The purpose of this phase II/III trial is to compare the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely ...
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Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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A Study to Examine Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Jacksonville, FL
The purpose of this study is to examine how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
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A Study to Evaluate the Safety of Lasofoxifene in Combination with Abemaciclib in Advanced or Metastatic ER+/HER2− Breast Cancer with ESR1 Mutation
Jacksonville, FL; Rochester, MN
The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
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A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Rochester, MN; Jacksonville, FL
The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
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FT516 in Subjects With Advanced Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
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Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Jacksonville, FL
The purpose of this study is to evaluate the timing of AVB-620 administration relative to surgery on the fluorescence and accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues in women undergoing surgery with primary, nonrecurrent and nonmetastatic breast cancer.
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Cabozantinib and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how well cabozantinib and nivolumab work in treating patients with endometrial cancer that has come back or spread to other places in the body.
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A Study to Evaluate Tazemetostat and Pembrolizumab to Treat Advanced Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary purpose of this study is to conduct a safety lead-in phase that identifies the safe recommended phase II dose for combination tazemetostat and MK-3475 (pembrolizumab) in patients with advanced urothelial carcinoma.
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An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Rochester, MN
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
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Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities in Patients with Known or Suspected Breast Cancer
Rochester, MN
The purpose of this study is to confirm that the Stereo Navigator accessory to an MBI Imging system can successfully guide the sampling of abnormal MBI findings in patients with known or suspected breast cancer.
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Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer
Rochester, MN
We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.
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Study Of The Bria-IMT Regimen And CPI Vs Physicians' Choice In Advanced Metastatic Breast Cancer. (BRIA-ABC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
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A Study To Evaluate The Safety And Efficacy Of Mesothelin-Targeting Logic-gated CAR T, In Participants With Solid Tumors That Express MSLN And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment ...
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A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with GRPR+, ER+, HER2- metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibito
Rochester, MN
The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).
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Lenalidomide And Dexamethasone With Or Without Bortezomib In Treating Patients With Previously Untreated Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...
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A Study To Evaluate Treatment Of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, MN
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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AB-2100, An Integrated Circuit T (ICT) Cell Therapy In Patients With Recurrent Clear-cell Renal Cell Carcinoma (CcRCC)
Scottsdale/Phoenix, AZ
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
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Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.
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A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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A Study Evaluating the Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).
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Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Rochester, MN
This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some ...
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Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well atezolizumab and capecitabine with or without bevacizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in treating ...
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Study of Breast Cancer Risk Assessment in Female Patients with Benign Breast Disease
Rochester, MN; Jacksonville, FL
The purpose of this study is to to bring molecular risk prediction for breast cancer into the clinical arena through: the establishment of a large tissue repository from a retrospective cohort of women with benign breast disease with complete and long-term clinical follow-up to identify those who developed breast cancer (cases) and those who did not (controls); the application of potential biomarkers of risk to this archival tissue set; and, the discovery of new, potentially relevant biomarkers of risk in fresh and frozen specimens of benign breast disease.
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Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Rochester, MN
This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.
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A Study to Compare Nivolumab or Brentuximab Vedotin Plus Combination Chemotherapy to Treat Patients with Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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A Study to Evaluate Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Eau Claire, WI
The purpose of this study is to evaluate androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
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Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer.
The names of the study drugs involved in this study are:
* Axatilimab (a type of antibody)
* Olaparib (a type of PARP inhibitor)
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A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Rochester, MN
The purpose of this study is to evaluate patient outcomes after undergoing 68Ga-PSMA PET/CT imaging prior to initiation of immunotherapy to identify PSMA PET/CT positive patients (estimated N=20) for long term follow up.
In adult patients with advanced, pathologically confirmed HCC who are not amenable to curative restriction, transplantation or ablative therapies, and have radiographically measurable disease by RECIST; eligible for atezolizumab/bevacizumab front line therapy.
- Specific Aim 1. To test the performance of novel biomarkers derived from PSMA PET/CT to measure response compared to RECIST criteria, in advanced HCC patients treated with immunotherapy.
- Specific Aim 2. To identify precision ...
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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment with Carvedilol to Reduce Incidence of Heart Failure
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.
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Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy
Rochester, MN
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
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Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurrent or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Goal: To determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing multiple myeloma.
The rationale for using MUC1-stimulated T-cells to treat multiple myeloma is twofold. The first is that T-cell therapies have been shown to be active in myeloma, making it an attractive disease model for the proposed study. The other is that we are expanding and using naturally occurring myeloma-fighting T-cells which may offer benefits, particularly with respect to longevity, as compared to the methods currently being employed using CAR-T and bispecific antibodies. This is highly significant as one of the ...
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Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer. The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will ...
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Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: ...
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Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.
PURPOSE: ...
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Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Rochester, MN
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
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A Study to Evaluate Trifluridine/Tipiracil Combined with Bevacizumab vs Trifluridine/Tipiracil to Treat Patients with Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer (mCRC).
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Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
Scottsdale/Phoenix, AZ
This randomized clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. After the surgery, patients are randomized to receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
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Improving Management of Breast Biopsy With Genetic Testing
Jacksonville, FL
The purpose of this study is to collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) and related single-nucleotide polymorphisms (SNPs) to final diagnosis of DCIS, invasive breast cancer or BBD; BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise. Also, to relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries. Additionally, to relate PRS (and related SNPs) to molecular markers in pathologic lesions and background ...
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Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Rochester, MN
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells ...
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A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if Regorafenib improves overall survival in refractory AGEC A randomized phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo) randomization and stratification by:
- Location of tumor (GEJ vs. gastric);
- Geographic region (Asia vs. Rest of World);
- Prior VEGF inhibitors (Yes vs No).
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A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Rochester, MN
This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
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ZTE MRI For Visualization Of Bone Cement, Breast Biopsy Markers
Rochester, MN
The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
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Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This randomized phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the ...
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Parotidectomy QOL Score
Rochester, MN
The objectives of this study are to explore the quality of life value of various surgical and functional outcomes after parotidectomy from a patient-centered perspective, develop a comprehensive patient-centered outcome measure after parotidectomy using a patient survey, and to validate the content of the above survey.
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Cell Saver During Tumor Resection
Rochester, MN
The aims of this study are to investigate the presence of tumor cells after filtration of autologous blood products by intraoperative cell saver, and to demonstrate the feasibility of intraoperative blood salvage during intralesional tumor resection.
Intraoperative blood salvage is a relatively safe and cost-effective alternative to allogeneic blood transfusion during procedures with large volume blood loss. Salvaged blood products are washed and filtered before reinfusion into the patient. Given the theoretical risk of systemically re-infusing samples contaminated with tumor cells, many surgeons refrain from using intraoperative blood salvage. Aside from a few small studies, there is a ...
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Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.
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Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
Rochester, MN
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
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Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Rochester, MN
The purpose of this study is to compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
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A Study to Evaluate the Impact of Non-invasive Tests for Bladder Cancer
Rochester, MN
Levels of bladder cancer-derived extracellular vesicles become undetectable after radical cystectomy in patients with localized bladder cancer. This study hopes to determine the levels of bladder cancer-derived extracellular vesicles pre- and post-RC.
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HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL; La Crosse, WI; Eau Claire, WI; Mankato, MN; Albert Lea, MN
This study utilizes a shorter course of radiotherapy for patients who need radiation after surgery or without surgery for head and neck cancers. Radiation is typically given in 6-7 weeks for head and neck cancer using X-ray therapy, but this study will administer treatment in approximately 3 weeks. To achieve this shorter course, proton therapy is used. This study aims to determine cancer control at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events ...
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A Study to Evaluate Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.
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Mayo Clinic Cancer Center Neuro-Oncology Program Registry and Biobank for the Study of Nervous System Tumors
Rochester, MN
Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.
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A Study to Evaluate Proton Therapy to Treat Low-Grade Glioma
Rochester, MN
The purpose of this study is to determine the feasibility of hippocampal-avoidance (HA) with proton therapy in suprasellar or midline low-grade gliomas (LGGs).
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Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells
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Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy
Jacksonville, FL
This project will be a pilot study aiming to describe the change of skin quality after initiation of Aromatase Inhibitor therapy in Breast Cancer survivors through use of VISIA CA technology and skincare intervention.
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Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors, The PNeoVCA Study
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of personalized neoantigen peptide administered in combination with pembrolizumab to patients with advanced solid tumors. Patients' tumors will be sequenced during a pre-registration component or will have had successful sequencing pre-study. A personalized neoantigen peptide vaccine containing up to 20 unique peptides will be manufactured for each qualifying patient based on the results.
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A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Rochester, MN
The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.
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Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
Rochester, MN
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
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Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant
Scottsdale/Phoenix, AZ
Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant
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Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ
This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue and can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping ...
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Pilot Study of PROS Monitoring
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the ability to capture PROs during patients’ radiation and during 3 months after.
Additionally, the study plans to conduct a retrospective chart review of prospectively accrued patients and ask subjects to complete a questionnaire.
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Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
Scottsdale/Phoenix, AZ
This is an international, multicenter Phase 2/3 study in subjects with locally-advanced unresectable or metastatic HER2+ GEC who have received prior treatment with a HER2-directed antibody, and have received 1 prior line of therapy in the advanced disease setting.
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A Study to Evaluate Biomarker/ALK Inhibitor Combinations in Treating Patients With Stage IV ALK Positive Non-squamous Non-small Cell Lung Cancer (The NCI-NRG ALK Protocol)
Rochester, MN
The purpose of this study is to determine whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer. This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ...
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A Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy in Patients with Gastric or Gastroesophageal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination ...
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A Study Using Chemotherapy to Treat Patients with Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to see the effect of a chemotherapy treatment for patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant.
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A Study to Optimize Patient Selection and Outcomes in Laryngeal Vascular Composite Allograft Transplantation
Scottsdale/Phoenix, AZ
In-depth qualitative interviews will be performed to explore beliefs of laryngotracheal transplant candidates, their caregivers, and clinicians about their perceptions and experience of the laryngotracheal transplantation process. In addition, we will explore the quality of life of patients with a laryngectomy.
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Surgical Drain Fluid for Detection of Molecular Residual Disease for HPV(-) Head and Neck Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with HPV(-) head and neck cancer.
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Tumor Treating Fields For The Treatment Of Leptomeningeal Metastases Of The Spine In Patients With Breast Or Lung Cancer
Jacksonville, FL
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
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A Study To Evaluate Tazemetostat Combined With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of tazemetostat in combination with R2 in subjects with Relapsed/Refractory Follicular Lymphoma (R/R FL), who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
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An Effectiveness and Safety Study of Daratumumab in Relapsed/Resistant Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess overall response rate, including complete and partial response, of daratumumab in patients with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
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Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
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Assessment of the Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy and Surgery, UTMOST Trial
Rochester, MN
In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally ...
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A Study to Evaluate M7824 with Concurrent Chemoradiation (cCRT) in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Rochester, MN
The primary purpose of this study is to evaluate safety and effectiveness in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.
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A Study of Low Dose Tamoxifen for Patients at High Risk for Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if counseling patients about low dose tamoxifen will influence the decision to take (or not take) preventive therapy among women at increased risk for breast cancer.
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Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer
La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Patient Survey of Molecular Breast Imaging
Rochester, MN
The purpose of this study is to gather qualitative information about patient comfort during MBI examinations. The primary aim is to assess patient comfort during MBI, relative to comfort during a mammogram. We also wish to identify factors that contribute to discomfort and patients’ willingness to have MBI in the future.
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A Study to Evaluate Gevokizumab with Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
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Study of HPN536 in Patients with Advanced Cancers Associated With Mesothelin Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
To assess the safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D).
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A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
Rochester, MN; Jacksonville, FL
The purpose of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A*02 expression.
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A Study Of GC012F (AZD0120), A CAR T Therapy Targeting CD19 And BCMA In Subjects With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
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A Study to Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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A Study of Using Palbociclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
Jacksonville, FL; Rochester, MN
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ibrutinib ...
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Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, interfere with the ability of cancer ...
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Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients with Tumor Induced Osteomalacia
Rochester, MN
This study aims to identify cases of FGF23-mediated oncogenic osteoomalacia in which the underlying phosphaturic mesenchymal has not been found and perform 68Ga-DOTATATE PET in these patients to localize the tumor.
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A Study of Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer
Rochester, MN
The purpose of this trial is to study how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
Rochester, MN
The goal of this clinical study is to learn how PLX3397 and paclitaxel work together to affect the growth of cancer cells in advanced solid tumors.
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Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age (PrE0405)
Rochester, MN
The purpose of this study is to evaluate venetoclax, bendamustine and rituximab as induction therapy in eligible untreated patients. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with ...
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Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area
Scottsdale/Phoenix, AZ
The aims of this study are to increase the number of Black consultants at MCA, make a meaningful impact on interactions among staff, leadership, and patients, and increase the number of Black staff in leadership roles beyond Diversity and Inclusion efforts.
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Water Vapor Ablation For Localized Intermediate Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.
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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer.
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MRI Techniques for early-stage detection of cancer
Rochester, MN
The purpose of this study is to develop 7T MRI techniques for early-stage detection of cancer, using both hydrogen (1H) and deuterium (2H) imaging.
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A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.
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Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer
Jacksonville, FL; Rochester, MN
This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
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Ultrasound-Guided Core Needle Biopsy To Stage Urothelial Carcinoma Of The Bladder (US UCB)
Rochester, MN
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
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A Phase I, Multi-Center, Open Label, Dose De-escalation and Expansion Study of Gemcitabine and Cisplatin with AG120 or Pemigatinib for Advanced Cholangiocarcinoma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib and pemigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for ...
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The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Rochester, MN
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. We then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
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A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM
Rochester, MN
A total of 207 subjects will be randomized into the study which will employ a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
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A Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)
Rochester, MN
The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.
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Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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Fertility Outcomes in Lymphoma Patients
Jacksonville, FL
The objectives of this study are to analyze impact of radiation on fertility, to correlate the clinical outcome of fertility after chemotherapy and or radiation, and to evaluate the different modalities and cost/benefit of fertility preservation in lymphoma patients
Lymphoma is a diversified disease with outcomes differing upon the types and subtypes of lymphoma as well as treatment modalities used. Fertility outcomes in patients treated with chemotherapy and/or radiation could vary and largely unknown.
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A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
Rochester, MN
The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by ...
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A Study of Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumors that are Recurrent or Cannot Be Removed by Surgery
Rochester, MN
The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).
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A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
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A Study to Evaluate Nutrition Therapy in Improving Immune System in Bladder Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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A Study to Evaluate Nutrition Therapy in Improving Immune System in Bladder Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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IRB#21-009968: Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy
Rochester, MN
The purpose of this study is to quantify the extent of sexual dysfunction in our patients to explore if there is a need for a prospective intervention, with the ultimate goal of improving the quality of life of our patients, with respect to sexual function.
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The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Rochester, MN
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. We then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
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A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
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A Study To Explore Quality Of Life According To Treatment Plan For Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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Mindfulness-Based Intervention (Muse-S™) as an Adjunct During Diagnostic Work-up in Patients Presenting to the Undiagnosed Mass Clinic (UMC).
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the feasibility of the Mindfulness-Based Intervention Meditation Program to provide an effective and sustainable solution for reducing stress often experienced by patients newly identified as having an unknown mass.
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Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
Rochester, MN
This phase II trial studies how well midostaurin and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia and fms-related tyrosine kinase 3 (FLT3) mutations. Midostaurin and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Bevacizumab with or without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients with Recurrent Glioblastoma Multiforme
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
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Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant
Jacksonville, FL
This phase I/II trial studies the best dose and side effects of ibrutinib when given together with lenalidomide and dexamethasone and how well they work in treating patients with multiple myeloma that are not eligible for transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work better in ...
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Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid ...
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S1400 Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
Rochester, MN
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include ...
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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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A Study of Ovarian Tissue Freezing for the Preservation of Fertility in Children
Rochester, MN
The purpose of this study is to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Since this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.
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Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...
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A Study To Evaluate Hyperthermic Intraperitoneal Chemotherapy To Treat Patients With Pancreatic Cancer And Peritoneal Metastasis
Rochester, MN
The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
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A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors
Rochester, MN
The purpose of this research is to study radiographic control at the 3 month time-point, the side effects (good & bad), survival outcomes and proof of this idea in patients who have had grid therapy for locally advanced bulky tumors of the heat and neck, thorax, abdomen and extremities.
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A Study to Evaluate Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...
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A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed/Refractory Multiple Myeloma
Rochester, MN
To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Patients will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.
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A Study of the Effect of Using MRI and Mammography Before Surgery in Patients with Stage I-II Breast Cancer
Rochester, MN
The purpose of this study is to assess whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves the ability to evaluate tumors and decide what kind of surgery is best for the patient.
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Brachial Plexopathy in Breast Cancer Patients Undergoing Supraclavicular/Axillary Radiation Therapy
Jacksonville, FL
The purpose of this sstudy is to perform a retrospectively review patients who underwent regional nodal radiation therapy involving the supraclavicular region of the shoulder and to identify patients that subsequently developed a brachial plexopathy.
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An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are double refractory to a PI and an IMiD.
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A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Rochester, MN
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
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Impact of Temperature-sensitive Radiofrequency Ablation in Patients with Malignant Biliary Obstructions Undergoing Biliary Stenting
Rochester, MN
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. Additionally, to describe the incidence of adverse events with combination RFA plus stenting.
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A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Rochester, MN
Some patients with head and neck cancer caused by human papilloma virus have a higher risk of recurrence. We are proposing to treat these patients with HPV vaccine with or without pembrolizumab during the window prior to surgery, in hopes of stimulating an immune response.
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A Study to Test the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no ...
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A Study to Analyze the Prevalence of Depression and Anxiety in Newly-diagnosed Breast Cancer Patients in a Community Hospital
La Crosse, WI; Albert Lea, MN; Austin, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to analyze the prevalence of mood disorders in newly-diagnosed breast cancer patients with use of specific questionnaires, aimed to diagnose clinically significant depression and anxiety, at a rural community hospital.
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A Study to Collect and Correlate the Data from Multiple Risk Assessments for Heart Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Rochester, MN
The purpose of this study is to collect and correlate the data from various cardiovascular risk asessments to successfully measure the risk of heart toxicity in patients receiving chemotherapy for breast cancer.
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Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.
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PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical control.
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Cyclophosphamide and Vaccine Therapy in Treating Patients with Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.
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Combination Chemotherapy Followed by Peripheral Stem Cell Transplant in Treating Young Patients with Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
Rochester, MN
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given before a peripheral stem cell transplant in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet known which ...
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A Study to Evaluate the Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate whether pembrolizumab (MK-3475 ) can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer. Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.
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A Study of R-ICE and Lenalidomide for Treating Patients with First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Rochester, MN
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
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A Single Patient Study Of Severe Fibrosis After Breast Radiation
Rochester, MN
This study is being performed to better understand the mechanisms behind severe radiation toxicity of a patient with severe fibrosis after breast radiation.
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A Study Of Quality Of Life After Thyroid Cancer Surgery
Scottsdale/Phoenix, AZ
The purpose of this study is to create a prospectively maintained database of patient and clinical factors, as well as collect survey data using validated quality-of-life metrics, to determine the impact and factors associated with quality of life after thyroid surgery for thyroid cancer.
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Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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A Study to Evaluate Daratumumab and Ibrutinib to Treat Relapsed / Refractory Chronic Lymphocytic Leukemia Treatment (DIRECT)
Jacksonville, FL
For cohort 1: The primary goal is to the determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on/or are previously treated with ibrutinib.
For Cohort 2: The primary goal is to determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment.
Secondary Goals:
For Cohort 1
-Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy.
-The overall incidence of MRD (minimal ...
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Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
Rochester, MN
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.
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Radiation Dermatitis In Breast Cancer Patients
Rochester, MN
The purpose of this study is to gather and analyze anonymous patient-reported experiences of radiation dermatitis in breast cancer patients undergoing radiotherapy.
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Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to see how well cabozantinib S-malate works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
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Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry
Jacksonville, FL
The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL.
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Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
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Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery
Eau Claire, WI
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
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A Blanket Protocol to Study Oral Regorafenib in Patients with Selected Sarcoma Subtypes
Jacksonville, FL; Rochester, MN
Regorafenib might or might not slow down the growth of your tumor, or shrink your tumor. Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GIST), but we do not know if regorafenib is useful to treat people with liposarcoma, osteosarcoma, and Ewing / Ewing-like sarcomas.
One drug like regorafenib, called pazopanib, is approved to treat some sarcomas, but is not approved to treat liposarcoma, osteosarcoma.
Since we do not know if any of these types of drugs help people with liposarcoma, osteosarcoma, or Ewing/Ewing-like sarcoma, our goal in this study ...
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Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or In Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.
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EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
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Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Scottsdale/Phoenix, AZ; Rochester, MN
In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people
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Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
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Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
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A Study To Explore Quality Of Life According To Treatment Plan For Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to see how well cabozantinib S-malate works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
-
Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry
Jacksonville, FL
The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL.
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Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Scottsdale/Phoenix, AZ; Rochester, MN
In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people
-
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
-
Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery
Eau Claire, WI
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
-
A Blanket Protocol to Study Oral Regorafenib in Patients with Selected Sarcoma Subtypes
Jacksonville, FL; Rochester, MN
Regorafenib might or might not slow down the growth of your tumor, or shrink your tumor. Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GIST), but we do not know if regorafenib is useful to treat people with liposarcoma, osteosarcoma, and Ewing / Ewing-like sarcomas.
One drug like regorafenib, called pazopanib, is approved to treat some sarcomas, but is not approved to treat liposarcoma, osteosarcoma.
Since we do not know if any of these types of drugs help people with liposarcoma, osteosarcoma, or Ewing/Ewing-like sarcoma, our goal in this study ...
-
Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or In Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.
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EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
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Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
-
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.
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A Study to Assess the Effectiveness and Safety of Ublituximab in combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of ublituximab in combination with umbralisib and venetoclax compared to ublituximab and umbralisib in subjects with previously-treated chronic lymphocytic leukemia (CLL).
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PET imaging with [18F]BF4
Rochester, MN
The objectives of the study are to determine the biodistribution of [18F]BF4 (TFB F 18 Injection) in patients with myeloma or endometrial cancer being treated with oncoviruses carrying the NIS reporter gene.
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Urinebased Molecular Testing versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate patient-reported preference for CxBladder Monitor compared to cystoscopy for patients on surveillance for NMIBC.
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A Study to Evaluate the Combination of Binimetinib and Palbociclib in Treating Patients with KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
Scottsdale/Phoenix, AZ
The purose of this study is to determine how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib ...
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Testing Proton Craniospinal Radiation Therapy Versus The Usual Radiation Therapy For Leptomeningeal Metastasis, RADIATE-LM Trial
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis).
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Testing the Addition of a New Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ...
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Using Induced-Pluripotent Stem Cells To Model Cancer Therapy-Related Adverse Events
Jacksonville, FL
The purpose of this study is to use patient blood cells to perform individualized in vitro modeling of cancer therapy-related toxicities.
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A Study To Evaluate Acalabrutinib With Or Without Obinutuzumab To Treat Early-Stage Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
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A Study of to Evaluate Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Registration Trial
Scottsdale/Phoenix, AZ
This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P
atients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) ...
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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Rochester, MN
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
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Erismodegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Rochester, MN
This phase II trial studies how well erismodegib and lenalidomide after stem cell transplant works in treating patients with multiple myeloma. Erismodegib and lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay the recurrence of myeloma after a stem cell transplant.
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Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
This study seeks to evaluate the efficacy and tolerability of veliparib in combination with FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan. This is a blinded study such that the Investigator and Subject will be blinded but AbbVie will be unblinded.
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Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida
Jacksonville, FL
The purpose of this study is to reduce disparities in cervical cancer screening and mortality among women vulnerable to health disparities based on social determinants of health. We are specifically interested in identifying non-traditional sites for cervical cancer screening and education regarding HPV vaccination outside of the primary care and gynecologic clinic settings.
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Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations
Rochester, MN
This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.
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DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.
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A Study to Evaluate the Safety and Effectiveness of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma Patients
Jacksonville, FL; Rochester, MN
The purpose of this single-dose escalation study is to evaluate the safety and effectiveness of CAR2 Anti-CD38 A2 CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma.
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...
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A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Effectiveness of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics, and preliminary effectiveness of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Mankato, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
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A Study to Evaluate Gilteritinib vs. Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.
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Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
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REFINE: Regorafenib Observational Study In Hepatocellular Carcinoma
Rochester, MN
The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.
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Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.
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A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:
Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.
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Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).
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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Albert Lea, MN; Mankato, MN; Rochester, MN
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or ...
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Nivolumab and Brentuximab Vedotin After Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Classical Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as nivolumab and brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread.
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A Study to Test the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.
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Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer
Rochester, MN; Jacksonville, FL
The purpose of this trial is to determine how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Hormone receptors like ER beta allow the body to respond appropriately to hormones. Triple negative means that the breast cancer does not express other hormone receptors called ER alpha, progesterone, and HER2. In some people with triple negative breast cancer, ER beta is overexpressed. Tumor cells that overexpress ER beta grow slower in the laboratory and ...
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3D-Printed Individualized External Breast Prostheses for the Post-mastectomy Patient.
Rochester, MN
This study aims to evaluate the efficacy of personalized 3D-printed external breast prostheses for patients opting out of reconstruction and assess their satisfaction with a survey.
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A Study to Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients for T-cell Directed Immunotherapy
Jacksonville, FL
The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.
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MC230302
Jacksonville, FL
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).
Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).
Hypothesis: Patients undergoing NSM will be willing ...
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A Study to Evaluate Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
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A Study of Bladder Filling Variations During Radiation Therapy in Patients Undergoing Radiation Treatment for Prostate Cancer
Jacksonville, FL
The purpose of this study is to examine bladder filling for radiation treatment to the prostate, and to evaluate how bladder fullness changes daily during radiation treatment.
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A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...
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Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
Rochester, MN
The purpose of this study is to anayze the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy ...
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A Study Comparing Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients with Chronic Lymphocytic Leukemia
La Crosse, WI; Eau Claire, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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A Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Rochester, MN
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
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Mindfulness-Based Intervention (Muse-S™) as an Adjunct During Diagnostic Work-up in Patients Presenting to the Undiagnosed Mass Clinic (UMC).
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the feasibility of the Mindfulness-Based Intervention Meditation Program to provide an effective and sustainable solution for reducing stress often experienced by patients newly identified as having an unknown mass.
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Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
Rochester, MN
This phase II trial studies how well midostaurin and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia and fms-related tyrosine kinase 3 (FLT3) mutations. Midostaurin and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Bevacizumab with or without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients with Recurrent Glioblastoma Multiforme
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
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Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant
Jacksonville, FL
This phase I/II trial studies the best dose and side effects of ibrutinib when given together with lenalidomide and dexamethasone and how well they work in treating patients with multiple myeloma that are not eligible for transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work better in ...
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Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid ...
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S1400 Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
Rochester, MN
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include ...
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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors
Rochester, MN
The purpose of this research is to study radiographic control at the 3 month time-point, the side effects (good & bad), survival outcomes and proof of this idea in patients who have had grid therapy for locally advanced bulky tumors of the heat and neck, thorax, abdomen and extremities.
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A Study to Evaluate Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...
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A Study of Ovarian Tissue Freezing for the Preservation of Fertility in Children
Rochester, MN
The purpose of this study is to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Since this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.
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Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...
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A Study To Evaluate Hyperthermic Intraperitoneal Chemotherapy To Treat Patients With Pancreatic Cancer And Peritoneal Metastasis
Rochester, MN
The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
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Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
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Family Cancer Literacy to Promote Mammography Screening among Navajo Women
Rochester, MN
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
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Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
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A Study to Quantify Microvasculature Imaging for Breast Cancer Detection and Monitoring
Rochester, MN
The purpose of this study is to apply new microvasculature imaging for differentiation of breast lesions, and prediction of response to preoperative chemotherapy.
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A Study to Evaluate Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.
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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative ...
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GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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The Mayo Clinic Breast Disease Survivors Study
Rochester, MN
This study will recruit breast cancer patients and survivors to take part in an ongoing study of the issues and concerns surrounding breast cancer survivorship. We will recruit both newly diagnosed patients as well as patients diagnosed within the past 5 years. Those who consent to the study will be asked to provide a series of questionnaires and blood samples over time. These data/samples will create a repository that will enable us to address many specific hypotheses both now and in the future. As part of the study DNA samples will be genotyped for common genetic variants ...
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Eau Claire, WI
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship
Jacksonville, FL
The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid. This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema.
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A Study of Taxane, Trastuzumab, and Pertuzumab With or Without Atezolizumab in Treating Metastatic Breast Cancer Patients
La Crosse, WI; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ...
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A Study to Evaluate Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
Eau Claire, WI; Rochester, MN; La Crosse, WI
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on ...
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Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer
Rochester, MN
The objective of this study is to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy.
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A Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
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A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread
Rochester, MN
The treatment for postmenopausal women diagnosed with hormone receptor positive (HR+) metastatic breast cancer (mBr) includes endocrine therapy However, de novo or acquired resistance to endocrine therapy remains an important clinical problem. Many hormone receptor positive breast cancers demonstrate overexpression of cyclin D. Cyclin D interacts directly with cyclin-dependent kinases 4 and 6 (CDK4/6) in an active protein complex that promotes cell proliferation; and consequently, CDK4/6 represents a potential therapeutic target for HR+ breast cancers.
LY2835219 represents a selective and potent small molecule inhibitor of CDK4/6. LY2835219 demonstrates suitable physical and pharmacokinetic (PK) properties, an acceptable toxicity profile in ...
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Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane with or without Chemotherapy in Treating Patients with Invasive RxPONDER Breast Cancer
Jacksonville, FL; Rochester, MN
This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...
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Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Rochester, MN
The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer
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A Study of Niraparib Combined with Pembrolizumab (MK-3475) in Patients who have Triple-Negative Breast Cancer or Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with niraparib and pembrolizumab (MK-3475) in patients who have triple-negative breast cancer that is advanced or has spread, or ovarian cancer that has returned after previous treatment.
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Determining Molecular Drivers of Radiation Dermatitis
Jacksonville, FL
The purpose of this study is to collect (i) pre-treatment (at the time of breast cancer surgery) normal skin and (ii) on-treatment (around the third week of treatment with breast radiation) irradiated skin with clinical hallmarks of radiation dermatitis (erythema and/or dry desquamation, documented by a photograph and graded by clinical criteria).
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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Eliminating Breast Cancer Surgery in Exceptional Responders with Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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Letrozole After Tamoxifen in Treating Women With Breast Cancer
La Crosse, WI
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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ADVANCE 2: ADdressing Views of African AmericaNs on CancEr Screening
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this research study is to understand the views and experiences of Non-Hispanic Black women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk and research participation.
This is a qualitative interview study. Study participation involved talking on the phone or videoconference (e.g., Zoom) for about 1 - 1 1/2 hours with a researcher.
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A Study to Optimize Endocrine Therapy Through Motivational Interviewing and Text Interventions
Albert Lea, MN
This study aims to compare an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence).
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Testing the Addition of an Anti-cancer Drug, ASTX727, to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic).
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A Study of Alisertib in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1)
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
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Olaparib and Atezolizumab Either Alone or in Combination in Treating Patients With Stage III-IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well olaparib and atezolizumab work either alone or in combination in treating patients with stage III-IV triple negative breast cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib and atezolizumab either alone or in combination would work better in patients with triple negative breast cancer.
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A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy
Jacksonville, FL
This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.
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Mammographic Images and Genetic Data for Breast Cancer Risk Prediction
Rochester, MN
The purpose of this study is to recruit a sample of women in the Rochester Epidemiology Project who had mammography screening at either Mayo Clinic or Olmsted Medical Center between 2009 and 2024 to get a biospecimen that can be used as a source of DNA for GWAS genotyping arrays. Using a case-cohort design, we will randomly sample a representative subcohort for comparison and include
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Breast-Conserving Surgery and Radiation Therapy in Patients with Multiple Ipsilateral Breast Cancer
Rochester, MN
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
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Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
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A Study Comparing Combinations of Chemotherapy for Treating Women who have Undergone Surgery for Node-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
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Hypofractionated Radiotherapy After Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.
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Study of Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma
Rochester, MN
This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.
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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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Eliminating Breast Cancer Surgery in Exceptional Responders with Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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Olaparib and Atezolizumab Either Alone or in Combination in Treating Patients With Stage III-IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well olaparib and atezolizumab work either alone or in combination in treating patients with stage III-IV triple negative breast cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib and atezolizumab either alone or in combination would work better in patients with triple negative breast cancer.
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A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy
Jacksonville, FL
This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.
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A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Rochester, MN
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
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A Study to See if Genetic Risk Estimation of Breast Cancer Influences the Use of Preventive Medication
Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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A Study of Pembrolizumab and Ruxolitinib Phosphate for Treating Patients with Metastatic Stage IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.
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Survivorship Experiences Post Cancer Treatment
Jacksonville, FL
The purpose of this study is to evaluate sexual well-being in minority women who have been diagnosed with cancer, and their partners.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.
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A Study of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Lobular Involution-Based Response to Antiendocrine Therapy for Women with Breast Atypical Hyperplasia
Jacksonville, FL
The goal of this study is to perform a quantitative measure of lobular involution (qLI) from breast biopsy samples obtained at baseline (surgery) and 12 months or at time of study discontinuation. The study will determine breast density (MMG) and correlate with qLI. The study will also determine the influence of chemoprevention therapies such as tamoxifen and letrozole on qLI.
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Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN; Jacksonville, FL
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
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Study to Evaluate Chemoembolization Combined with Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer
Rochester, MN
The purpose of this study is to determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.
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Tamoxifen Citrate, Letrozole, Anastrozole, Or Exemestane With Or Without Chemotherapy In Treating Patients With Invasive RxPONDER Breast Cancer
Mankato, MN
This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
Albert Lea, MN; Rochester, MN; Mankato, MN; Jacksonville, FL; La Crosse, WI
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.
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Reishi Mushroom for Fatigue And/or Arthralgias for Patients With Breast Cancer on Aromatase Inhibitors
Rochester, MN; Albert Lea, MN; Mankato, MN
The purpose of this study is to evaluate the effect of Reishi mushroom extracts on aromatase-inhibitor toxicities, specifically fatigue, and arthralgias, compared to placebo. Other aims include examining the side effects of Reishi mushroom extracts and its impact on quality of life and mood, as compared to placebo.
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Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Eau Claire, WI
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
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Letrozole in Treating Postmenopausal Women with Ductal Carcinoma in Situ
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.
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Dendritic Cell Therapy After Cryosurgery in Combination With Pembrolizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Remove by Surgery
Rochester, MN
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients ...
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Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer
Rochester, MN
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC
Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination
Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy
The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer ...
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Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
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A Study to Compare Administering Olaparib Concurrently With Radiotherapy vs. Radiotherapy Alone in Treating Patients With Inflammatory Breast Cancer
La Crosse, WI; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
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Pre-Op / Post-Op Hypofractionation Radiotherapy in Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of ths study is to determine the outcomes and toxicity profile of preoperative treatment including chemotherapy and hypofractionated radiotherapy for different breast cancer risk groups.
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Cancer Prevention: Stories For Change In Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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Evaluating Surgical Treatment Related Differences In Patient Satisfaction And Health-related Quality Of Life In Breast Cancer Survivors In The Long-term Survivorship Period
Rochester, MN
This study is being done to determine the long-term effects of different kinds of breast surgeries on women’s health-related quality of life from the patient’s perspective. The information will also provide information to assist in improving the quality of care given to patients.
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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
Mankato, MN
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.
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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
Mankato, MN; Albert Lea, MN; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.
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Effects of Cognitive Function, Post-op Fatigue and Quality of Life Comparing General vs Regional Anesthesia for Non-eloquent Brain Tumors Resection
Jacksonville, FL
The aim of the study is to create a registry to prospectively collect pre-operative, during surgery and post-operative data, questionaries will assess (at baseline before the surgery, 3-4 weeks, and at 3-6 months) cognitive function, assessed with a Mini-mental State Examination (MMSE), PROMIS Fatigue 7a form, quality of life (QoL), assessed using the SF-12 questionnaire, quality of sleep assessed using PROMIS Sleep disturbance 7a form (1 week after surgery).
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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A Study to Evaluate the Optune® (Tumor Treating Fields) Concomitant with RT & TMZ to Treat Newly-diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients with Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
Rochester, MN
This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare ...
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AML: Treatment of Relapse after Transplant or Extended Maintenance of Remission – Investigational Study (ARTEMIS)
Effectiveness of MT-401 in Patients with AML Following Stem Cell Transplant
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate safety and effectiveness of MT-401 administration to patients with AML, who have received their first allogeneic HSCT.
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Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of the ALLO-605-201 study is to assess the safety, effectiveness, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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A Study of MCLA-128 in Patients with Solid Tumors Harboring an NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.
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Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...
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EORTC-1709-BTG_CCTG-CE.8: A Study to Compare Marizomib in Combination with Standard Radiochemotherapy vs. Radiochemotherapy Alone in Patients with Newly- diagnosed Glioblastoma MIRAGE
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of marizomib in combination with Temozolomide-based radiochemotherapy versus standard Temozolomide-based radiochemotherapy alone in newly diagnosed glioblastoma patients.
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Study to Evaluate the Efficacy and Safety of Lutathera in Patients with Grade 2 and Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
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MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life to back up evidence that less radical margins of excision may be just as safe.
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Congenital Heart Disease Skin Punch Biopsy Sample Collection
Rochester, MN
The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use, and Reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
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A Study to Collect Ovarian Tissue from Girls Undergoing Fertility-preserving Cryopreservation
Rochester, MN
The purpose of this study is to study the handling of ovarian tissue, cryopreservation technology, and oocyte maturation for female pediatric cancer patients and other female patients whose future fertility will be affected due to a disease or treatment.
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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Study of Gastric Cancer and Limited Peritoneal Metastasis Using Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy
Rochester, MN
The purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.
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A Study to Investigate the Effects of GC4419 on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer
Jacksonville, FL
The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
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Embolization Before Ablation Of Renal Cell Carcinoma (EMBARC)"
Rochester, MN
The purpose of this study is to estimate the safety of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma, and to estimate the feasibility of patient enrollment in such a trial.
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Testing The Role Of DNA Released From Tumor Cells Into The Blood In Guiding The Use Of Immunotherapy After Surgical Removal Of The Bladder, Kidney, Ureter, And Urethra For Urothelial Cancer Treatment, MODERN Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are ...
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A Study of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) with Doxorubicin and Cisplatin in Pediatric Patients with Pelvic and Abdominal Rhabdomyosarcoma
Rochester, MN
The primary purpose of this study is to assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and Cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors, and to assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.
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Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the Reservoir]
Rochester, MN; La Crosse, WI
The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts. This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique. These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers ...
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Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Rochester, MN
The purpose of this study is to determine how polyamine depletion impacts extracellular intratumoral guanidinoacetate abundance.
In addition: to determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ; to assess the feasibility of longitudinal microdialysis for combined pharmacokinetic and pharmacodynamic analysis within live human gliomas in situ in the postoperative setting; to assess the CNS pharmacokinetics of DFMO and AMXT 1501; to assess the short-term safety of study drugs in patients with high-grade gliomas.
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A Study To Evaluate The Safety, Effectiveness And Tolerable Dose Of Arlocabtagene Autoleucel (BMS-986393) In Novel Combinations In Participants With Relapsed And/or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
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Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of the ALLO-605-201 study is to assess the safety, effectiveness, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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A Study of MCLA-128 in Patients with Solid Tumors Harboring an NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.
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Study to Evaluate the Efficacy and Safety of Lutathera in Patients with Grade 2 and Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
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Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...
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EORTC-1709-BTG_CCTG-CE.8: A Study to Compare Marizomib in Combination with Standard Radiochemotherapy vs. Radiochemotherapy Alone in Patients with Newly- diagnosed Glioblastoma MIRAGE
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of marizomib in combination with Temozolomide-based radiochemotherapy versus standard Temozolomide-based radiochemotherapy alone in newly diagnosed glioblastoma patients.
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MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life to back up evidence that less radical margins of excision may be just as safe.
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Congenital Heart Disease Skin Punch Biopsy Sample Collection
Rochester, MN
The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use, and Reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
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A Study to Collect Ovarian Tissue from Girls Undergoing Fertility-preserving Cryopreservation
Rochester, MN
The purpose of this study is to study the handling of ovarian tissue, cryopreservation technology, and oocyte maturation for female pediatric cancer patients and other female patients whose future fertility will be affected due to a disease or treatment.
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Scottsdale/Phoenix, AZ
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
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Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Rochester, MN
The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
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Safety and Efficacy of ALLO-715 and ALLO-647 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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Spearhead 1 Study In Subjects With Advanced Synovial Sarcoma Or Myxoid/Round Cell Liposarcoma
Jacksonville, FL
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
La Crosse, WI; Scottsdale/Phoenix, AZ
The purpose of this stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
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18F-DOPA PET in Sarcoma Patients
Jacksonville, FL
The purpose of this study is to identify early response biomarkers from biological or functional imaging to better align with clinical trial endpoints and minimize sarcoma patient toxicities.
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Human Blood and Tissues Repository for Neuroscience Research
Jacksonville, FL
The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).
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Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement (PACER)
Rochester, MN; Jacksonville, FL
The purpose of this study is to to evaluate the rate of overall survival (OS) at two years in patients with either borderline or locally advanced pancreatic cancer who receive electron beam intraoperative radiation therapy (IORT) following chemotherapy and radiation therapy.
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A Study of Defitelio (Defibrotide) for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)
Jacksonville, FL
The purpose of this study is to compare the defibrotide prophylaxis arm vs. standard of care arm for the prevention of aGvHD.
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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Scottsdale/Phoenix, AZ; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.
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A Study to Evaluate Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer
Jacksonville, FL
The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.
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A Study to Evaluate 68Ga- PSMA-Dual Contrast PET/MRI and PET/CT for Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
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A Study to Evaluate Chemotherapy and Radiation Therapy With or Without Surgery to Treat Patients With Head and Neck Cancer
Rochester, MN
The purpose of this study is to determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC, to assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens, to define the acute and late toxicity of each treatment regimen, to evaluate whether there are differences in patient’s QOL, perception of side effects, and performance status between treatment arms, to establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation.
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A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance ...
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Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors
Jacksonville, FL
The purpose of this trial is to evaluate the safety and effectiveness of first time in human engineered T-cell therapies, in participants with advanced tumors.
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A Study of the Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study will utilize Rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.
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Image-based Mapping of Brain Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.
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A Safety to Evaluate the Safety and Effectiveness of Pressurized Intraperitoneal Aerosolized Chemotherapy in Ovarian, Uterine, Colorectal, and Gastric Cancer Patients
Jacksonville, FL
The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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A Study to Evaluate Gemcitabine, Cisplatin, and Nab-Paclitaxel to Treat Patients with High-Risk Liver Bile Duct Cancer Before Surgery
Rochester, MN
The purpose of this study is to evaluate how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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A Study for Cerebral Open Flow Microperfusion
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
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A Study to Evaluate CHIP and Hematological Toxicity After PRRT in Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.
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Bispecific Aptamer Engagers For Cancer Therapy
Jacksonville, FL
The purpose of this work is to develop brain cancer-specific small synthetic oligonucleotides (aptamers) that easily cross the BBB and capable of forming distinct three-dimensional configurations, enabling them to bind to target molecules with high affinity and specificity. The scope of this work is to develop brain cancer specific aptamers and combine them with patient-derived autologous T cells to enhance the tumor targeted immune reaction.
Our three major project aims are the creation of the Bispecific Aptamer T Cell Engagers (BATE) (aim 1), the creation of autologous T cell – BATE (aim 2), and finally the combination ...
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MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer
Rochester, MN
This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.
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Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Jacksonville, FL
The purpose of this study is to compare local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
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AUTO1 in Relapsed or Refractory B-ALL
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AUTO1 (t-cells) in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (r/r B-ALL).
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A Study to Evaluate Stereotactic Radiosurgery Versus Hippocampal-Avoidant Whole Brain Radiotherapy for 10 or Fewer Brain Metastases from Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT).
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Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
Jacksonville, FL; Rochester, MN
This phase I/II trial studies the side effects and best dose of carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.
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Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to compare the 1-year cumulative incidence of severe GVHD (from day of HCT) defined as Grade III-IV acute GVHD (aGVHD) and/or chronic GVHD (cGVHD) that requires systemic immunosuppression and to compare the disease free survival (DFS) (from time of randomization) in children and young adults (AYA) with acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), and Myelodysplastic Syndrome (MDS) who are randomly assigned to haploHCT or to an 8/8 adult MUD HCT.
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A Study to Evaluate Optune vs. Prophylactic Cranial Irradiation (PCI) in Non-Small Cell Lung Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases. Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity. As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression ...
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Study of NanoKnife for Ablation of Prostate Cancer in Low and Intermediate Risk Patients
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS
Rochester, MN
The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.
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A Study of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Rochester, MN
The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Rochester, MN
The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
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A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Scottsdale/Phoenix, AZ
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
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Spearhead 1 Study In Subjects With Advanced Synovial Sarcoma Or Myxoid/Round Cell Liposarcoma
Jacksonville, FL
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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Safety and Efficacy of ALLO-715 and ALLO-647 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
La Crosse, WI; Scottsdale/Phoenix, AZ
The purpose of this stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
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A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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Study to Determine the Impact of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (a chemical tracer that highlights certain cells during imaging) During Planning for Proton Beam Radiation Therapy.
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.
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Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders
Jacksonville, FL
The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.
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BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
Jacksonville, FL
Piloting the BeWell360-CG model, in conjunction with usual care delivery for lung cancer patients in Palliative Care, will longitudinally improve the wellbeing and quality of life of care givers within and outside of clinical care settings, in such a way as to positively impact the quality of care of patients themselves. We hypothesize that PC staff trained in the BeWell360-CG will be able to identify the most common CG-centric needs and guide CGs to improve their QoL and personal wellbeing. In doing so, we further hypothesize that there will be an improvement in patient-reported and quality of care ...
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Ommaya Placement For Biomarker Collection
Rochester, MN
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.
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Oligomets Pancreas SBRT
Jacksonville, FL
The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.
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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR)
Rochester, MN
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Rochester, MN
The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.
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Combination Chemotherapy and Surgery in Treating Young Patients with Wilms Tumor
Rochester, MN
This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Bilateral Wilms tumor and children who are a special risk for forming tumors in both kidneys. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may ...
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Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem ...
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Nurse-Led Acupressure Intervention for Patients Receiving Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.
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A Study to Compare Whole Brain Radiotherapy and Memantine to Stereotactic Radiosurgery vs. Stereotactic Radiosurgery Alone to Treat Patients with Cancer That Has Spread to the Brain After Earlier Stereotactic Radiosurgery
Jacksonville, FL
The purpose of this study is to compare the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory.
The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on ...
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Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML
Jacksonville, FL; Rochester, MN
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.
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Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
Jacksonville, FL; Rochester, MN
This phase I/II trial studies the side effects and best dose of carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.
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Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to compare the 1-year cumulative incidence of severe GVHD (from day of HCT) defined as Grade III-IV acute GVHD (aGVHD) and/or chronic GVHD (cGVHD) that requires systemic immunosuppression and to compare the disease free survival (DFS) (from time of randomization) in children and young adults (AYA) with acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), and Myelodysplastic Syndrome (MDS) who are randomly assigned to haploHCT or to an 8/8 adult MUD HCT.
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A Study to Evaluate Optune vs. Prophylactic Cranial Irradiation (PCI) in Non-Small Cell Lung Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases. Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity. As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression ...
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Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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Selection Of Allogeneic Hematopoietic Cell Donors Based On KIR And HLA Genotypes
Rochester, MN
The purpose of this study is to test whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will ...
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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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A Study to Compare the Effectiveness and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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A Study of Nivolumab and Multi-fraction Stereotactic Radiosurgery with or without Ipilimumab in Treating Participants with Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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A Study to Evaluate Chemoradiotherapy with or without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
La Crosse, WI; Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer
Rochester, MN
This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.
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AUTO1 in Relapsed or Refractory B-ALL
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AUTO1 (t-cells) in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (r/r B-ALL).
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A Study to Evaluate Stereotactic Radiosurgery Versus Hippocampal-Avoidant Whole Brain Radiotherapy for 10 or Fewer Brain Metastases from Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT).
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Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Jacksonville, FL
The purpose of this study is to compare local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
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Biochemically Recurrent Prostate Cancer Detection With Integration of PSMA PET imaging and Extracellular Vesicle-Based Tumor Monitoring
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to develop an inexpensive and non-invasive blood test that can help refine the identification of patients with PSMA-positive metastatic lesions following biochemical recurrence.
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A Study of JNJ-68284528, a Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the study is to characterize the safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the effectiveness of JNJ-68284528 (Phase 2).
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Axicabtagene Ciloleucel Expanded Access Study
Rochester, MN
A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.
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Study Evaluating the Safety and Effectiveness of JCARH125 in Subjects with Relapsed and/or Refractory Multiple Myeloma (EVOLVE)
Rochester, MN
The purpose of this study is to determine the safety and effectiveness of JCARH125 in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
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A Study of Vaccine Therapy in Treating Patients With Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to evaluate the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
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A Study Evaluating the Safety and Effectiveness of JCAR017 to Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the effectiveness and safety of JCAR017 in adult subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the effectiveness and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of ...
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A Study of the Effectiveness and Safety of CTL019 in Adult Patients with Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy and safety of CTL019 in adult patients with relapsed or resistant diffuse large B-cell lymphoma.
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A Study Comparing Anitocabtagene Autoleucel To Standard Of Care Therapy In Participants With Relapsed/ Refractory Multiple Myeloma (IMMagine-3)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC).
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Study of Efficacy and Safety of CTL019 in Adult ALL Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness and safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary follow-up is 1 year from cell infusion. Safety will be assessed until the end of the treatment and primary follow-up phase.
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Stereotactic Body Radiation Therapy with Immunotherapy for the Treatment of Mesothelioma
Rochester, MN
The purpose of this study is to evaluate whether adding stereotactic body radiation therapy (SBRT) to immunotherapy as part of second line treatment for mesothelioma will improve the modest response rate of immunotherapy alone, provide local control/cytoreduction to sites of gross disease, and decrease symptomatic burden while improving outcomes.
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Study to Evaluate the Safety and Effectiveness of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Relapsed/Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward from Phase 1 into Phase 2, and to evaluate the effectiveness of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma in Phase 2.
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A Multi-Center Study Evaluating KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.
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Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.
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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR)
Rochester, MN
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Combination Chemotherapy and Surgery in Treating Young Patients with Wilms Tumor
Rochester, MN
This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Bilateral Wilms tumor and children who are a special risk for forming tumors in both kidneys. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may ...
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Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Rochester, MN
The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.
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Nurse-Led Acupressure Intervention for Patients Receiving Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.
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Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem ...
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A Study to Compare Whole Brain Radiotherapy and Memantine to Stereotactic Radiosurgery vs. Stereotactic Radiosurgery Alone to Treat Patients with Cancer That Has Spread to the Brain After Earlier Stereotactic Radiosurgery
Jacksonville, FL
The purpose of this study is to compare the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory.
The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on ...
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Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML
Jacksonville, FL; Rochester, MN
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.
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A Study to Compare the Effectiveness and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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A Study of Nivolumab and Multi-fraction Stereotactic Radiosurgery with or without Ipilimumab in Treating Participants with Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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A Study to Evaluate Chemoradiotherapy with or without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
La Crosse, WI; Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
Rochester, MN; Jacksonville, FL
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic ...
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Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
Rochester, MN
This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine ...
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Preclinical investigation of immunotherapeutic efficacy and safety of a novel oncolytic vesicular stomatitis virus expressing extracellular matrix-destructing enzymes in combination with immune checkpoint inhibitors in pancreatic adenocarcinoma
Jacksonville, FL
The purpose of this study is to bioengineer a novel vesicular stomatitis virus (VSV) to express extracellular matrix (ECM) destructing enzymes to overcome desmoplastic pancreatic adenocarcinoma (PDAC) tumor microenvironment and assess the oncolytic virus (OVs’) therapeutic safety and efficacy as monotherapy and in combination with immune checkpoint inhibitors (ICIs) in preclinical settings. This effectiveness will be investigated in vitro, ex vivo and in vivo.
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A Study of PY314 in Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
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Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
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A Study to Evaluate the Safety and Tolerability of KTE-X19 in Adults with Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to evaluate the safety and tolderability of KTE-X19 in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Small Lymphocytic Lymphoma (r/r SLL).
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A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers
Rochester, MN
The purpose of this study is threefold: the first aim is to use patient-derived fresh tumor tissue to create cell lines and 3D tumor models (i.e. organoids) that preserve the characteristics of the original tumor. The preservation of the original tumor's drug resistance/response profile will be a major focus of this aim. The second aim is to conduct high-throughput testing of various drugs (e.g., virotherapy, immunotherapy) on these cell lines and 3D tumor models. The completion of the second aim is an important step towards developing a platform that can help guide treatment decisions for future patients, based on the drug ...
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Manufacturing Outcomes with Patient Factors from Multiple Myeloma Patients Prescribed Ciltacabtagene Autoleucel
Rochester, MN
The purpose of this study is to identify patient factors that are associated with low-viability or low-dose out-of specification (OOS) in ciltacabtagene autoleucel drug product (DP).
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Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer (HOTT)
Rochester, MN
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...
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A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
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GPRC5D-directed CAR T Cell Therapy in Participants with Relapsed or Refractory Multiple Myeloma
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.
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A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).
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A Study to Evaluate the Safety and Effectiveness of Idecabtagene Vicleucel to Treat Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information.
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A Study to Assess the Effectiveness and Safety of Durvalumab Alone or Combined with Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.
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A Safety and Effectiveness Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta®.
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A Study Evaluating the Safety and Effectiveness of UCART Targeting CS1 in Patients with Relapsed/Refractory Multiple Myeloma (MELANI-01)
Rochester, MN
The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCARTCS1A (t-cells) and to determine the Maximum Tolerated Dose (MTD).
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A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) (KarMMa-4)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and to determine the optimal dose of bb2121 in subjects with high risk, (HR) newly -diagnosed multiple myeloma (NDMM).
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FT819 in Subjects With B-cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and clinical activity of FT819 in r/r B-cell malignancies, including the effect of a step-fractionated dosing schedule on mitigating safety risks and improving tolerability.
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Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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Study to Determine the Impact of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (a chemical tracer that highlights certain cells during imaging) During Planning for Proton Beam Radiation Therapy.
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.
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BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
Jacksonville, FL
Piloting the BeWell360-CG model, in conjunction with usual care delivery for lung cancer patients in Palliative Care, will longitudinally improve the wellbeing and quality of life of care givers within and outside of clinical care settings, in such a way as to positively impact the quality of care of patients themselves. We hypothesize that PC staff trained in the BeWell360-CG will be able to identify the most common CG-centric needs and guide CGs to improve their QoL and personal wellbeing. In doing so, we further hypothesize that there will be an improvement in patient-reported and quality of care ...
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Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders
Jacksonville, FL
The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.
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Ommaya Placement For Biomarker Collection
Rochester, MN
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.
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Oligomets Pancreas SBRT
Jacksonville, FL
The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.
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Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the safety and effectiveness of bb2121 (Ide-Cel) combinations in subjects with relapsed/refractory multiple myeloma. It also aims to evaluate different agents and their doses/schedules to improve clinical effectiveness in combination with bb2121.
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A Study of JNJ‐68284528 Out‐of‐Specification (OOS) for Commercial Release in Patients with Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the effectiveness of cilta-cel OOS based on overall response of partial response (PR) or better (overall response rate, ORR) to treat multiple myeloma.
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Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.
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A Study to Evaluate CTX110 in Subjects with Relapsed or Refractory B-Cell Malignancies
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness CTX110 in subjects with relapsed or refractory B cell malignancies.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
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A Study to Evaluate Yttrium-90 Therapy for Radiation Lobectomy
Jacksonville, FL; Scottsdale/Phoenix, AZ
The Patient Group 1 primary objective is to measure the distribution of 90Y glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day postradioembolization study-specific non-FDG PET/CT scan. Correlate this measurement with mean lobar absorbed radiation dose and embolic load given to patients and time taken to achieve adequate Future Liver Remnant (> 40% of total liver volume) to determine if there is an optimal lobar dose and embolic load.
The Patient Group 2 primary objectives are to assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy, and to assess progression-free survival between ...
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Inherited Breast Cancer Study
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to improve the interpretation of mutations in breast cancer predisposition genes. This will be accomplished by recruiting members of families found to carry deleterious (mainly protein truncating) mutations and evaluating co-segregation of the mutations with cancer within families.
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Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases
Rochester, MN
Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.
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A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
Rochester, MN
This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving ...
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A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
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Understanding the Relationship Between Benign Breast Tissue, Benign Breast Disease, and Breast Cancer Development
Jacksonville, FL
The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status.
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A Study to Evaluate Remote Monitoring in Cancer Care
Rochester, MN
The objectives of this study are to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, and to develop patient-specific algorithms to predict the trajectory of CRS and or neurotoxicity and time to escalation of medical intervention is needed.
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Infection Outcomes Assessment of Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction
Rochester, MN
The purpose of this study is to demonstrate the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two-stage postmastectomy alloplastic prepectoral breast reconstruction, to support an FDA Premarket Approval (PMA) Application.
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MC230813 A Study of Golcadomide with Rituximab prior to CAR-T with Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
Jacksonville, FL; Albert Lea, MN; Scottsdale/Phoenix, AZ; Mankato, MN; La Crosse, WI; Rochester, MN; Eau Claire, WI
The purpose of this study is to evaluate efficacy as measured by the disease control rate (CMR, PMR, and NMR) by Lugano 2014 PET-CT based assessment after 2 cycles of therapy.
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Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and ...
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relaped/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate HPN217 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with relapsed/ refractory multiple myeloma.
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Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the safety and effectiveness of bb2121 (Ide-Cel) combinations in subjects with relapsed/refractory multiple myeloma. It also aims to evaluate different agents and their doses/schedules to improve clinical effectiveness in combination with bb2121.
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A Study of JNJ‐68284528 Out‐of‐Specification (OOS) for Commercial Release in Patients with Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the effectiveness of cilta-cel OOS based on overall response of partial response (PR) or better (overall response rate, ORR) to treat multiple myeloma.
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Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.
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A Study to Evaluate CTX110 in Subjects with Relapsed or Refractory B-Cell Malignancies
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness CTX110 in subjects with relapsed or refractory B cell malignancies.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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A Study to Compare the Effectiveness and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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A Study of Nivolumab and Multi-fraction Stereotactic Radiosurgery with or without Ipilimumab in Treating Participants with Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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A Study to Evaluate Chemoradiotherapy with or without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
La Crosse, WI; Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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Experiences of Acupuncture among Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine the feasibility and perceived effectiveness of acupuncture for breast cancer-related symptoms.
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A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.
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SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
Jacksonville, FL
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
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Open Nipple Sparing Mastectomy (NSM)
Rochester, MN
The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.
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Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index
Rochester, MN
Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.
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A Consortium Trial to Evaluate Proton vs. Photon Therapy for Patients with Non-metastatic Breast Cancer
Jacksonville, FL
The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.
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A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy
Rochester, MN
The purpose of this study is to determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen, and to measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.
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A Study to Evaluate CC-98633 to Treat Subjects with Relapsed and/or Refractory Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this Phase 1 first-in human study is to evaluate the safety and preliminary efficacy of CC-98633 in adult subjects with relapsed and/or refractory MM. A challenge in CAR T-cell development is to generate a product that consistently expands, persists, and mediates durable antitumor responses after infusion. Multiple preclinical and translational studies have suggested that the differentiation state of adoptively transferred T cells can influence the ability of these cells to persist and promote durable antitumor immunity. Less differentiated T cells have shown an increased ability to proliferate, persist, and mediate responses in mouse tumor models compared to more differentiated effector memory cell subsets in certain studies.
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A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration
Eau Claire, WI; Rochester, MN; Scottsdale/Phoenix, AZ
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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Conventionally Fractionated Vs. Hypofractionated
Comprehensive Nodal Irradiation For Breast Cancer Using Pencil Beam Scanning ProtonTherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the 2-year rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated pencil beam scanning proton therapy (PBS-PT) is non-inferior to conventionally-fractionated PBS-PT.
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A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Jacksonville, FL
The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.
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CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
Rochester, MN
The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.
The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified ...
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Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant
Rochester, MN
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
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A Study to Develop and Validate Hybrid Molecular Imaging to Transform the Care of Hepatocellular Carcinoma Patients
Rochester, MN
The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.
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A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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A Study to Evaluate Quality of Life Over Time in Patients Treated with CAR-T Cell Therapy Compared with Stem Cell Transplantation in Hematologic Malignancies
Rochester, MN
The purpose of this study is to evaluate quality of life over time in patients treated with CAR-T therapy compared with autologous and allogeneic stem cell transplant.
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Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and ...
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A Study to Assess Accelerated Resolution Therapy for Cancer Related Trauma and Distress
Jacksonville, FL
The purpose of this study is to quantitatively evaluate accelerated resolution therapy (ART) for treatment of cancer distress and psychological trauma.
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FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
Rochester, MN
This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.
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A Study to Compare Single Fraction Stereotactic Radiosurgery Compared with Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to compare how well single fraction stereotactic radiosurgery works versus fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time.
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The NeoGlioma Study
Jacksonville, FL; Scottsdale/Phoenix, AZ
This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.
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A Study to Evaluate the Role of Gut Microbiome in Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.
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Pre-operative Vs. Post-operative Radiosurgery For Metastatic Brain Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
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A Registry for Children Treated with Proton Radiation Therapy
Rochester, MN
The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.
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A Study to Collect Adipose Harvest for Mesenchymal Stem Cell Derivation in Patients with Head & Neck Cancer
Rochester, MN
The purpose of this study is to collect adiopose tissue to derive mesenchymal stem cells.
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Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...
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A Study to Evaluate Software On Cross-sectional Imaging Evaluation of Microwave-ablated Liver Tumors
Rochester, MN
The primary purpose of this study is to assess the accuracy of the Philips High Precision 3D Ablation Solution software on cross-sectional imaging evaluation of microwave-ablated liver tumors, and to determine whether software accuracy varies based on patient, tumor, and technical procedural factors.
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Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL; Mankato, MN; Albert Lea, MN; Eau Claire, WI; La Crosse, WI
The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.
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ROR1771: A Prospective Observational Study of Proton Stereotactic Body Radiation Therapy and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
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Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
Rochester, MN
The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
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Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.
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Hypofractionated Radiation Therapy in Treating Participants With Prostate Cancer High-Risk Features Following Radical Prostatectomy
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
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A Study to Develop Liquid Biopsy for Pediatric Brain Tumor Patients
Rochester, MN
The purpose of this study is to confirm detection of the H3K27M mutation in patient biofluids (CSF, blood, urine, saliva) and uncover the molecular histone (alkaline protein) profile of H3K trimethylation and H3S phosphorylation in the circulating nucleosomes isolated from the biofluids of patients with H3K27M tumors.
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Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission
Rochester, MN; Jacksonville, FL
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. ...
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A Study of Massage Therapy Alone and in Combination with Acupuncture for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction
Rochester, MN
The purpose of this study is to explore the effectiveness of massage therapy combined with acupuncture in breast cancer patients recovering from autologous tissue reconstruction with the hope that the combination will augment the benefit obtained by massage therapy alone.
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Pembrolizumab, Chemotherapy, and Radiation Therapy With or Without Surgery in Treating Patients With Anaplastic Thyroid Cancer
Rochester, MN
This phase II trial studies how well pembrolizumab, chemotherapy, and radiation therapy work with or without surgery in treating patients with anaplastic thyroid cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as docetaxel and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, chemotherapy, and radiation therapy with or without surgery ...
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Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the ...
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A Study to Evaluate Cancer Distress, Psychological Trauma, and Resiliency in Hospitalized Hematopoietic Stem Cell Transplant Patients
Jacksonville, FL
The purpose of this study is to better understand the distress experience of hospitalized patients undergoing hematopoietic stem cell transplant (HSCT), and to examine the relationship between cancer distress, psychological trauma, and resiliency over time.
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A Study to Evaluate Cancer Patients' Experience with Bevacizumab- induced, Wound-healing Complications
Rochester, MN
The purpose of this study is to characterize the experiences and psychosocial impact of bevacizumab-wound-healing toxicities in cancer patients.
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Radiation Therapy and Docetaxel in Treating Patients with HPV-Related Oropharyngeal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with docetaxel my kill more tumor cells.
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A Study To Explore If It Is Possible To Successfully Obtain Optical Coherence Tomography (OCT) Imaging And Data While Patients Undergo Brain Surgery
Jacksonville, FL
The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.
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Cerebrospinal Fluid Biomarkers for Brain Tumors
Rochester, MN
The purpose of this study is to help generate a repository of Cerebrospinal Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.
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Ommaya at Biopsy
Rochester, MN
The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.
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ROR1771: A Prospective Observational Study of Proton Stereotactic Body Radiation Therapy and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
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Proton or Photon RT for Retroperitoneal Sarcomas
Rochester, MN
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.
Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, ...
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A Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
Rochester, MN
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
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A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
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Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radiation Injury After Treatment for Brain Metastases
Rochester, MN
This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.
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A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.
Scottsdale/Phoenix, AZ
This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.
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Comparison Of Acute Toxicities Between Patients Treated With Protons Or Intensity Modulated Radiation Therapy After Surgery For The Treatment Of Endometrial Or Cervical Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Scottsdale/Phoenix, AZ
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
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Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma
Rochester, MN
The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. IRD is a three-drug regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy either with ixazomib or lenalidomide. 09/23/2019: Upon review of the interim analysis that suggested inferior progression-free survival in the ixazomib maintenance arm, there will be no further randomizations into the ...
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68GaFAPI-46 PET/CT for Pancreatic Ductal Adenocarcinoma
Rochester, MN
The purpose of this study is to examine the utility of 68GaFAPI-46 PET/CT imaging in adult patients with biopsy-proven Pancreatic Ductal Adenocarcinoma (PDA) who have no prior treatment for their PDA and who are expected to undergo surgical resection following NAT.
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A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer
Rochester, MN
The purpose of this study is to assess late > grade 3 GI and/or GU toxicity of interest with the hypofractionated regimen with proton beam therapy or IMRT (late defined as 3 to 24 months after protocol RT).
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A Study to Compare Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Albert Lea, MN; Eau Claire, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in ...
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A Study Comparing Proton and Photon Radiation Outcomes in Prostate Cancer Patients
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
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A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to observe adverse events and effectiveness of hypofractionated concurrent chemoradiotherapy for the treatment of pancreatic cancer.
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A Study to Investigate LYL797 in Adults With Solid Tumors
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.
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A Study to Compare Standard-Dose Combination Chemotherapy with High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Resistant Germ Cell Tumors
Rochester, MN
The purpose of this study is to compare standard-dose combination chemotherapy to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving ...
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Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
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Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
Rochester, MN
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
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Safe Omission of Pelvic Lymph Node Dissection During Radical Prostatectomy
Jacksonville, FL
This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.
Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, ...
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Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Rochester, MN
The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing ...
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Patient Outcomes After Hepatic Artery Infusion Pump Placement
Rochester, MN
The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).
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A Study Using Gallium-68 PSMA-11 and C-11 Choline PET Imaging to Detect Metastatic Prostate Cancer in Patients
Rochester, MN
The purpose of this study is to examine PSMA and C-11 Choline PET in patients with suspected metastatic prostate cancer who have been imaged with 11C-Choline PET clinically and with PSMA PET (either Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 PSMA 1007) in order to demonstrate their utility in detecting prostate cancer.
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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
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3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer
Rochester, MN
The overall goal of this project is to study a new 3D ultrasound imaging technology for evaluation of axillary lymph nodes in patients with breast cancer.
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A Study to Evaluate the Feasibility of Intraoperative Microdialysis (tissue sampling) during Neurosurgery for Central Nervous System Malignancies
Rochester, MN
Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
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International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Jacksonville, FL
The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.
The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.
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A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients
Rochester, MN
The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.
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SPORT-DMG
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.
Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study
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A Study to Determine the Effects of COVID-19 in Cancer Patients
Scottsdale/Phoenix, AZ; Mankato, MN; La Crosse, WI; Eau Claire, WI; Rochester, MN
The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.
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A Study to Test Concussion Return to Baseline after Elective Craniotomy Procedure
Jacksonville, FL
The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.
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Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Rochester, MN
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a ...
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A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
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A Study to Evaluate Treating Post-Mastectomy Radiation Injury in Breast Cancer Patients with Adipose-Induced Regeneration of Breast Skin (AIR Breast)
Jacksonville, FL
The primary purpose of this study is to identify the therapeutic effect of Adipose-Induced Regeneration (AIR) in radiation-induced skin injury of post-mastectomy breast cancer patients.