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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 Study to Evaluate Enfortumab Vedotin to Treat Metastatic Squamous Cell Carcinoma of the Penis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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A Study of X4P-001 in Patients with Advanced Renal Cell Carcinoma
No Locations
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 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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Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
Rochester, MN
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 (AMP-514) in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy. The primary objectives are to determine the maximum tolerated dose (MTD) or highest protocol-defined dose (HPDD); in the absence of exceeding the MTD of MEDI-551 in combination with MEDI0680 (AMP-514); and to evaluate the safety, tolerability, and clinical activity of MEDI-551 in combination with MEDI0680 (AMP-514).
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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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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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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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A Study of SC-007 in Subjects With Advanced Cancer
No Locations
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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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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Institutional Analysis of Non-metastatic Pancreatic Adenocarcinoma Outcomes from 2011-2016
No Locations
The purpose of this study is to evaluate survival of patients with resectable, borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC) separately and as a group.
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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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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 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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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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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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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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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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Combination Therapies with Adagrasib in Patients with Advanced NSCLC With KRAS G12C Mutation
Jacksonville, FL; Rochester, MN
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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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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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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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 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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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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Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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A Study Evaluating the Safety and Effectiveness of Therapies in Patients with Metastatic Colorectal Cancer (INTRINSIC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
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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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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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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 ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study Of PARG Inhibitor ETX-19477 In Patients With Advanced Solid Malignancies (ERADIC8)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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 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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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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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 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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Synergy with Grid Therapy and Immune Checkpoint Inhibitors in Stage IV Non-Small Cell Lung Cancer
Rochester, MN
The primary objective of this study is to describe the safety and toxicity of grid + immunotherapy in stage IV NSCLC using CTCAE v5.0.
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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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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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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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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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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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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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A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients With Advanced or Metastatic Renal Cell Carcinoma
No Locations
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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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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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 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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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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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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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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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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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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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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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 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 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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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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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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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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Phase III Copanlisib in Rituximab-refractory iNHL
Rochester, MN
Assess the efficacy and safety of copanlisib monotherapy
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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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Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors.
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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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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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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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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 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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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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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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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 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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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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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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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. ...
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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 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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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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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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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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GA-68 PSMA-11 PET TO EVALUATE MALIGNANT GLIOMA RECURRENCE – A PILOT STUDY
Rochester, MN
The purpose of this study is to evaluate the utility of PSMA PET for differentiating recurrent glioma from radiation effect via pre-operative PSMA PET/CT in adult patients undergoing craniotomy for this indication.
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Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The phase 1 primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in subjects with relapsed or refractory multiple myeloma. This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in subjects with t(11;14)-positive multiple myeloma. The phase 2 primary objective is to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in subjects with t(11;14)-positive multiple myeloma and to evaluate patient ...
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Ph 1b Study to Evaluate GSK2110183 in Combination with Bortezomib and Dexamethasone in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ
Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety, tolerability and clinical activity of the MTD(s) identified in Part 1, including a pharmacokinetic cohort.
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Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Rochester, MN; Jacksonville, FL
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.
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A Study to Evaluate the Safety and Effectiveness of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma
Rochester, MN
The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.
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Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior Chronic Myeloid Leukemia Therapies
Jacksonville, FL
The purpose of this study is determine the safety, tolerability, pharmacokinetics and activity of K0706.
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A Study to Evaluate Encapsulated Rapamycin to Prevent Progression of Familial Adenomatous Polyposis in Patients
Scottsdale/Phoenix, AZ
The purposes of this study are to analyze the frequency and severity of adverse events associated with low-dose encapsulated rapamycin in Familial Adenomatous Polyposis (FAP), to determine the recommended phase 2 dose (RP2D) based on assessment of safety, long-term tolerability, optimal blood levels, and clinical benefit, and to determine the effectiveness of eRapa in delaying polyp progression in patients with FAP compared to historic controls.
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Electronic Patient Reporting of Symptoms During Cancer Treatment
La Crosse, WI; Eau Claire, WI; Mankato, MN
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
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DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Jacksonville, FL
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
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Blood-Based Biomarkers in Sarcoma: A ‘Multi-Omics’ Approach
Rochester, MN
The purpose of this research is to determine whether circulating tumor DNA, RNA or proteins can be detected in the blood of patients with sarcoma. We are also interested in learning if these levels change over time while receiving chemotherapy. Patients with advanced sarcoma who will receive chemotherapy will be asked to participate. Study participation involves blood-draws of approximately 4 tablespoons of blood at each of 4 separate time-points as well as access to archived tumor tissue, or fresh tumor tissue at the time of clinically indicated biopsy or surgery. We hypothesize that circulating tumor DNA, RNA and/or proteins ...
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Hepatobiliary Cancer Research Engagement Among Patients and Communities
Jacksonville, FL
The purpose of this study is to assess community needs and attitudes toward participating in hepatobiliary cancer research for relevant, translatable, and sustainable research partnership.
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A Study of BBI503 in Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.
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A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of Part 1 (dose escalation) of this study is to establish the MTD and/or RP2D of ELU001 in subjects who have advanced, recurrent or refractory FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.
The primary purpose of Part 2 (Tumor Group Expansion Cohorts) of this study is to evaluate anti-tumor activity of ELU001 in subjects who have moderate or high FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.
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Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).
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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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A Study to Evaluate AL101 Monotherapy in Patients with Notch Activated Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is designed to evaluate the effectiveness and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic Triple Negative Breast Cancer (TNBC); Notch activation will be determined by a Next Generation Sequencing (NGS) test.
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A Study to Evaluate Ulixertinib to Treat Patients with Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted.
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Risk Factors for Recurrence in Endometrial Cancer Patients
Rochester, MN
The purpose of this study is to identify those clinical, immunochemical, or molecular risk factors associated with an increased risk of distant recurrence in “high-intermediate” risk endometrial cancer patients.
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A Study to Establish a Research Tissue Bank for Myeloproliferative Neoplasms
Scottsdale/Phoenix, AZ
The purpose of this study is to credential novel therapeutic approaches which can then be transitioned to the clinic for near-term mechanism based clinical trials in this research consortium. There is a need for new treatments for myelofibrosis (MF) patients based on laboratory insight into disease pathogenesis. We will use primary patient samples to understand how different genetic mutations contribute to MF development and to test novel treatment approaches.
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A Study of LNK01002 in Patients With Primary (PMF) or Secondary Myelofibrosis (PV-MF, ET-MF) or Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (MF), or MF due to polycythemia vera (PV-MF), or essential thrombocythemia (ET-MF), or with acute myeloid leukemia (AML).
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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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A Study of Poziotinib in Patients with NSCLC With EGFR or HER2 Exon 20 Insertion Mutation
Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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A Study of the Safety and Drug/Body Interactions of BGB-3111 for Patients with B-Cell Lymphoid Malignancies
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and treatment effects of a new drug known as BGB-3111 in patients who have B-cell lymphoid malignancies.
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A Study to Evaluate Safety of Enapotamab Vedotin in Patients with Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the trial is to establish the tolerability of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors.
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Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Jacksonville, FL
This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.
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Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
Jacksonville, FL; Rochester, MN
The purpose of this trial is to assess the safety and effectiveness of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation following progression on or after endocrine-based therapy.
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Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
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Metastatic Non-Small Cell Lung Cancer Insomnia
Rochester, MN
The purpose of this study is to evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.
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Financial Difficulty in Patients With Blood Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250), a physician survey (n=100), and a practice survey completed by each site enrolling patients onto this study. A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.
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Study of SBP-101 in Pancreatic Cancer
Scottsdale/Phoenix, AZ
This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.
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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the ...
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Caris Biorepository Research Protocol
No Locations
The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.
The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.
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A Study to Evaluate INSTILADRIN® in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive NMIBC
Rochester, MN
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that Instiladrin nadofaragene firadenovec is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of Instiladrin in patients that are "BCG Unresponsive" which refers to patients with high grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
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Plasma Proneurotensin as a Predictive Biomarker for Breast Cancer in Genetically Predisposed Patients
Rochester, MN
The purpose of this study is to assess whether elevated fasting plasma proneurotensin levels are common in patients genetically predisposed to breast cancer.
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A Study to Evaluate Maximizing Anti-PD-1 Therapy By Monitoring T Cell Responses In Melanoma, Lung and Other Cancer Types
Rochester, MN
The purpose of this study is to monitor T cell responses from patients with advanced cancer who are being treated with an anti-PD (programmed death)-1 monoclonal antibody, and compare them with clinical outcomes.
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A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Scottsdale/Phoenix, AZ
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
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A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of STP938 as a single agent in adult subjects with R/R B-cell and T-cell lymphomas.
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Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control for Primary Indeterminate Lesions or Small Choroidal Melanoma
Rochester, MN
The purpose of this study is to determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
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A Study to Evaluate Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced Melanoma
Rochester, MN
The purpose of this study is to investigate how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
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A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
La Crosse, WI
The purpose of this study is to determine how megakarocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survivial and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakatocyte survival and function. Through chart review, the study team will look at the relationship different blood components and different breast cancer diagnosis.
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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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A Study of SGN-B7H4V in Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and who have a mutation in the speckle type BTB/POZ protein (SPOP) gene. M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Characterizing Ultrasound Vibroelastography Features of Ocular Tumors
Rochester, MN
The purpose of this study is to characterize ultrasound vibro-elastography features of ocular tumors.
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Sexual and Gender Minority (SGM) for Cancer Studies
Rochester, MN
The purpose of this study is to document the beliefs, attitudes, and experiences regarding NIH cancer research participation expressed by SGM cancer patients.
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64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Rochester, MN
The purpose of this study is to evaluate 64Cu-SAR-bisPSMA and 67Cu-ARbisPSMA administered to participants with metastatic castrate resistant prostate cancer (mCRPC). This study is to be conducted in 3 phases: a Dosimetry Phase, a Dose Escalation Phase and a Cohort Expansion Phase.
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Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 in patients with eligible advanced solid tumors, determine the maximum tolerated dose and assess preliminary anti-tumor activity.
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INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Rochester, MN
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115
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Addressing Overdiagnosis in Thyroid Cancer
Rochester, MN
The purpose of this study is to develop a radiological multivariate model to distinguish between malignant and benign CT-identified detected thyroid nodules.
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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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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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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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A Study of ASP8273 versus Erlotinib or Gefitinib as First-Line Treatment for Patients with Stage IIIB/IV Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the study is to evaluate progression free survival, using independent radiologic review, of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer that has epidermal growth factor receptor (EGFR) activating mutations.
This study will also assess overall survival, overall response rate, progression free survival assessed by the investigator, disease control rate, duration of response, safety of ASP8273, quality of life, and patient-reported outcome parameters.
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Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients with Relapsed or Relapsed/Refractory Multiple Myeloma
Rochester, MN
This phase I/II trial studies the side effects and best dose of ixazomib and to see how well it works when given together with pomalidomide and dexamethasone in treating patients with relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide and dexamethasone can modify and regulate the immune system and may stop cancer cells from growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment for relapsed or relapsed/refractory multiple myeloma.
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Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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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 Outpatient Blinatumomab in Subjects with Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Jacksonville, FL
The purpose of this study is to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
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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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Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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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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Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and who have received 1-3 prior lines of therapy.
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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Patients with Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma
Rochester, MN
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).
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A Study of Personalized Molecular Markers to Transform Treatment of High Grade Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.
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Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
Jacksonville, FL
The purpose of this study is to provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy). In addition, long-term safety and overall survival will be collected.
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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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Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.
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Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
Jacksonville, FL
The goal of this clinical research study is to learn if BL-8040 in combination with cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia (AML) that has relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
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A Study to Provide Expanded Access for the Treatment of Cancers with Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of AMG 397 in Subjects With Multiple Myeloma, NHL, and AML
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AMG 397 by estimating the maximum tolerated doses (MTDs) and/or biologically active doses.
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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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Using Social Media for Public Health Education on Melanoma within the Hispanic Population
Scottsdale/Phoenix, AZ
The purpose of this study is to develop online education video-based modules to educate the Hispanic community. This will allow for the widespread, cost-effective scaling of our educational platform. Also, to demonstrate improvement in knowledge and practice of sun-smart behaviors. We will achieve this goal through a baseline, three-month, and one-year follow-up questionnaire examining melanoma knowledge and sun-safe behaviors (sunscreen use, sun protective clothing use, self-skin examination). Understanding the risks of melanoma and actively reducing one's risk of melanoma will be key to reducing the incidence of melanoma and improving overall survival in this population.
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Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
No Locations
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
TP-0903 is a novel oral inhibitor that targets AXL kinase. Preclinical studies have shown promising antitumor activity of TP-0903 as a single agent against a variety of tumor types in both in vitro and in vivo studies. This first-in-human study is conducted to identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TP-0903 administered orally to patients with advanced solid tumors. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity profiles.
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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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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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Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology
Rochester, MN
The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
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Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
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Cognitive Function After Treatment of Primary CNS Malignancy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate cognitive function and to determine neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent.
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Study to Evaluate the Safety and Effectiveness of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes in Women with Breast Cancer Using Magseed Markers as an Alternative to the Current Practice of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
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A Study of Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma
Rochester, MN
The main purpose of this study is to assess the effectiveness and safety of treatment with anetumab ravtansine versus vinorelbine for progression free survival in patients with stage IV mesothelin overexpressing type of malignant pleural mesothelioma. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
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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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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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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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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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Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma
Jacksonville, FL; Rochester, MN
This study is evaluating whether administration of glucarpidase will allow faster clearance of high-dose methotrexate and thus fewer side effects related to methotrexate therapy.
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Study of SBP-101 in Pancreatic Cancer
Scottsdale/Phoenix, AZ
This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.
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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the ...
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Caris Biorepository Research Protocol
No Locations
The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.
The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.
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A Study to Evaluate INSTILADRIN® in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive NMIBC
Rochester, MN
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that Instiladrin nadofaragene firadenovec is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of Instiladrin in patients that are "BCG Unresponsive" which refers to patients with high grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
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A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of STP938 as a single agent in adult subjects with R/R B-cell and T-cell lymphomas.
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Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control for Primary Indeterminate Lesions or Small Choroidal Melanoma
Rochester, MN
The purpose of this study is to determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
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A Study to Evaluate Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced Melanoma
Rochester, MN
The purpose of this study is to investigate how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
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A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
La Crosse, WI
The purpose of this study is to determine how megakarocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survivial and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakatocyte survival and function. Through chart review, the study team will look at the relationship different blood components and different breast cancer diagnosis.
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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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A Study of SGN-B7H4V in Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and who have a mutation in the speckle type BTB/POZ protein (SPOP) gene. M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Alternate Doses and Dosing Schedules of Belantamab Mafodotin for the Treatment of Triple-Class Recurrent and/or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the 24-week grade 3/4 keratopathy-free rate of an alternative dose/dosing schedule for belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (RRMM).
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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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Characterizing Ultrasound Vibroelastography Features of Ocular Tumors
Rochester, MN
The purpose of this study is to characterize ultrasound vibro-elastography features of ocular tumors.
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Sexual and Gender Minority (SGM) for Cancer Studies
Rochester, MN
The purpose of this study is to document the beliefs, attitudes, and experiences regarding NIH cancer research participation expressed by SGM cancer patients.
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64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Rochester, MN
The purpose of this study is to evaluate 64Cu-SAR-bisPSMA and 67Cu-ARbisPSMA administered to participants with metastatic castrate resistant prostate cancer (mCRPC). This study is to be conducted in 3 phases: a Dosimetry Phase, a Dose Escalation Phase and a Cohort Expansion Phase.
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Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 in patients with eligible advanced solid tumors, determine the maximum tolerated dose and assess preliminary anti-tumor activity.
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INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Rochester, MN
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115
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Addressing Overdiagnosis in Thyroid Cancer
Rochester, MN
The purpose of this study is to develop a radiological multivariate model to distinguish between malignant and benign CT-identified detected thyroid nodules.
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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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Synergy with Grid Therapy and Immune Checkpoint Inhibitors in Stage IV Non-Small Cell Lung Cancer
Rochester, MN
The primary objective of this study is to describe the safety and toxicity of grid + immunotherapy in stage IV NSCLC using CTCAE v5.0.
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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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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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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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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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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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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 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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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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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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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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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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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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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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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 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 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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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 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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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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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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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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Phase III Copanlisib in Rituximab-refractory iNHL
Rochester, MN
Assess the efficacy and safety of copanlisib monotherapy
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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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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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A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients With Advanced or Metastatic Renal Cell Carcinoma
No Locations
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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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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Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors.
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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
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Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
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Cognitive Function After Treatment of Primary CNS Malignancy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate cognitive function and to determine neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent.
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Study to Evaluate the Safety and Effectiveness of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes in Women with Breast Cancer Using Magseed Markers as an Alternative to the Current Practice of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
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A Study of Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma
Rochester, MN
The main purpose of this study is to assess the effectiveness and safety of treatment with anetumab ravtansine versus vinorelbine for progression free survival in patients with stage IV mesothelin overexpressing type of malignant pleural mesothelioma. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
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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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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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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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Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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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 Outpatient Blinatumomab in Subjects with Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Jacksonville, FL
The purpose of this study is to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
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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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Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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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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Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma
Jacksonville, FL; Rochester, MN
This study is evaluating whether administration of glucarpidase will allow faster clearance of high-dose methotrexate and thus fewer side effects related to methotrexate therapy.
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A Study to Evaluate TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the safety and effectiveness of TAK-981 in combination with anti-CD38 monoclonal antibodies. TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.
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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 Determine the Effectiveness and Safety of Luspatercept in Patients with Myelodysplastic/ Myeloproliferative Neoplasms with Ring Sideroblasts and Thrombocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. ...
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Colorectal Cancer and Peripheral Neuropathy Study
Jacksonville, FL
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
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Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
No Locations
The purpose of this study is:
- To assess whether a team based care model applied to distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
- To assess whether health promotion tools such as psychoeducation applied to non-distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
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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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Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
No Locations
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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Study of Lenzilumab (KB003) in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
Rochester, MN
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
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A Study of the Safety, Tolerability, Drug/Body Interactions, Biological and Clinical Activity of MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, drug/body interactions, and the biological and clinical activities of MSB0011359C (M7824) at different dose levels given to patients who have metastatic or locally advanced solid tumors.
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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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Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1) vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma.
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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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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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Pragmatic Comparative Clinical Trial to Determine Optimal Initial Therapy for Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN; La Crosse, WI
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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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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A Study to Assess LXH254 in Patients with Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma
Rochester, MN
The purpose of this study is to evaluate combinations, using LXH254 as a backbone, which may help overcome intrinsic and acquired resistance to BRAF targeted therapy as well as offer new treatment options for NRAS melanoma patients.
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Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
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Evaluate REC-4881 in Patients With FAP (TUPELO)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
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A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Study to Improve health-related quality of life (HRQOL) in Black Prostate Cancer Patients (CaPQoL) through Whole Person Survivorship Care
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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University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities
Jacksonville, FL
The purpose of this study is to establish at least 200 patient-derived cancer xenografts (PDXs), and to utilize these PDXs in preclinical testing of single agents and drug combinations to guide precision cancer medicine decision-making with a focus upon the predominant racial/ethnic minority populations residing in California.
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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
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Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for Locally Advanced or Metastatic ER+/HER2− Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the PFS of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer with an ESRl mutation.
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Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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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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Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
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A Study to Evaluate Combination Therapy to Treat Newly-diagnosed Diffuse Anaplastic Wilms Tumors and Relapsed Favorable Histology Wilms Tumors
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Rochester, MN
The purpose of this study is to evaluate how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) 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.
This trial may help doctors find out what effects, good and/or bad, regimen UH-3 ...
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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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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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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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A Phase 2, Multicenter, Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label
Rochester, MN
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.
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Trastuzumab Emtansine in Treating Older Patients With Human Epidermal Growth Factor Receptor 2-Positive Stage I-III Breast Cancer
Rochester, MN
This phase II trial studies how well trastuzumab emtansine works in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer. HER2 is a protein found on the surface of cancer cells that helps them to grow and spread. Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of the tumor cells and blocking their ability grow and spread.
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PLX3397 Phase 3 Study for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug PLX3397 in the treatment of tumour of pigmented villonodular synovitis or giant cell tumor of the tendon sheath in subjects, for whom surgical removal of the tumour would cause more harm than good. The main purpose of this study is to gather information about the investigational drug PLX3397, which may help to treat these tumours. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either PLX3397 or matching placebo for 24 weeks. A number of ...
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A Study to Evaluate the Effectiveness and Safety of rAd-IFN Administered With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.
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A Patient Access Program of Olaratumab for the Continued Treatment of Soft Tissue Sarcoma
Jacksonville, FL
The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).
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A Follow-Up Study of Subjects Treated With ACTR T Cell Product
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to follow subjects who were treated with ACTR after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorder
Rochester, MN
The purpose of this Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for ...
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Study to Investigate the Safety and Effectiveness of Two Doses of the Antibody Drug GSK2857916 in Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to investigate the safety and effectiveness of two doses of the antibody drug GSK2857916 in multiple myeloma patients who had 3 or more prior lines of treatment, are refractory to a proteasome inhibitor and an immunomodulatory agent and have failed an Anti-CD38 Antibody (DREAMM 2).
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A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
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A Study to Evaluate the Safety and Effectiveness of TT-00420 in Adults with Advanced Cholangiocarcinoma
Rochester, MN
The purpose of this trial is to evaluate the effectiveness and safety of TT-00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment and discontinued due to disease progression, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
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A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML
Rochester, MN
The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory AML after treatment with standard therapy.
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Management of Locoregional Recurrent Breast Cancer
Rochester, MN
The aims of this study are to develop an institutional recurrent breast cancer registry, including prior and future patients, which will be prospectively maintained to characterize the current management of patients with locally recurrent breast cancer. Specifically, investigate the extent of operation, subsequent operations, use of radiation and re-radiation and timing and nature of systemic therapies and variables associated with selection of these modalities, and to analyze breast-cancer specific outcomes including rates of local re-recurrence, regional and distant recurrence, recurrence-free and breast-cancer specific survival.
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Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
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Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue
Rochester, MN
The purpose of this study is to test the effectiveness of a remote monitoring program with health coaching for patients with cancer related fatigue.
The primary objective is to assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory and the Cancer Fatigue Scale/ MFSI-SF. Secondary objective is to assess the effect of the program on quality of life by administering the LASA questionnaire.
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An Open Label Extension Study of BMS-911543 In Subjects With Myelofibrosis
Rochester, MN
The purpose of this study is to provide patients with myleofibrosis (MF) who participated in study CA215001 access to BMS-911543.
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Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other Myelodysplastic /Myeloproliferative Neoplasias, and Acute Myeloid Leukemia
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment until disease progression. If a complete response is observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start of response.
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Recruitment to Promote Cancer Health Equity Across Florida
Jacksonville, FL
The purpose of this study is to qualitatively examine, via individual and group interviews, a tailored intervention utilizing virtual human technology 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. Virtual human technology uses computerized agents with a human-like body and naturalistic dialogue to deliver educational information and model behaviors. Virtual human technology is used in a variety of health contexts and has the potential to increase the diversity of NCI-sponsored clinical trials by reducing common barriers to NCI-sponsored clinical ...
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A Study of the Safety and Effectiveness of TH-302 Combined with Gemcitabine and Compared with Gemcitabine Alone for Previously Untreated Patients with Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if TH-302 combined with Gemcitabine versus Gemcitabine alone is as safe and effective in the treatment of patients who have first-line metastatic pancreatic adenocarcinoma.
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A Study to Evaluate Circulating Tumor Cells from Patients with Treatment-Refractory Advanced Solid Tumors Managed in the Early Cancer Therapeutics Program
No Locations
The overall objective of this research is to evaluate and define the molecular and biological characteristics of CTCs from advanced solid tumor patients who have progressed on standard therapy.
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MRD Guided, Fixed Duration Therapy With Loxo-305 and Venetoclax for Previously Untreated Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to determine if a new drug combination, pirtobrutinib and venetoclax, will help Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cancer, as well as learn more about the side effects of this drug combination.
Everyone in this study will receive pirtobrutinib and venetoclax. Venetoclax is U.S. Food and Drug Administration (FDA) approved for the treatment of CLL and SLL. Pirtobrutinib is currently being studied in patients with CLL but it is not FDA approved yet. This drug combination is still experimental and is not approved by the FDA. Discontinuation of pirtobrutinib ...
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Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms
Rochester, MN
The purpose of this study is to learn about the combination of choline salicylate and selinexor. We want to find out more about the side effects of the combination, what doses are safe for patients, and to collect information on how lymphoma responds to the drug combination. The doses of both drugs received will depend on when the patient is enrolled on to the study.
The drug combination of selinexor and choline salicylate is experimental and isn’t approved by the U.S. Food and Drug Administration (FDA). Selinexor is FDA approved when given with dexamethasone for previously treated relapsed multiple myeloma. Selinexor is ...
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A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to select the optimal dose of naporafenib + trametinib to be studied in Stage 2 and to compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).
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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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A Study to Evaluate Immune-related Biomarkers for Pathological Response in Stage II-III HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate invasive disease-free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ breast cancer with residual disease post-neoadjuvant chemotherapy, and to evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.
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Venetoclax and Vincristine Liposomal in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia
Rochester, MN
This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine liposomal, 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 venetoclax ...
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Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.
The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].
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Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of OBT076, and to define the maximum tolerated dose (MTD) and/or the RP2D of OBT076.
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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)
Rochester, MN
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer and Cervical Cancer: a Phase II Clinical Study
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI
The purpose of this study is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.
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Indigenous Peoples Engagement in Cancer Research Arizona
Scottsdale/Phoenix, AZ
The purpose of this study it to develop culturally appropriat, respectful, trusted, and collaborative means to engage and recruit American Indians (AI) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.
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A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Rochester, MN
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
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A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and efficacy of [177Lu]Lu-FAP-2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC.
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A Study to Evaluate Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpse of this study is to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for Telisotuzumab Vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate effectiveness in the selected population(s) (Stage 2).
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Study of DF9001 in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected ...
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A Study to Evaluate Hepcidin Mimetic in Patients With Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to test different doses of PTG-300 to identify a dose that is safe and is possibly effective for reducing the need for phlebotomies in patients with Polycythemia vera who require routine phlebotomies.
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A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Rochester, MN
The purpose of this study is to characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
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A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
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IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
Rochester, MN
The purpose of this study is to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR), and to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to OS
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Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.
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A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab And A Combined Regimen Of Mosunetuzumab And Venetoclax In Participants With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Rochester, MN
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) ...
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A Study of Tyrosine Kinase Inhibitor ICP-022 in Patients With r/r B-Cell Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
The main purpose of this study is to assess the maximal dose of ICP-022 that can be safely administered.
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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
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Asynchronous Skin Cancer Risk Using 3D Total-Body Photograph
Rochester, MN
The purpose of this study it to compare two approaches for executive health skin cancer screening to assess the level of agreement between asynchronous 3D-Total Body Photography based examination and dermatology clinician exam.
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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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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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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 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 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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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 Outpatient Blinatumomab in Subjects with Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Jacksonville, FL
The purpose of this study is to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
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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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Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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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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Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and who have received 1-3 prior lines of therapy.
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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Patients with Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma
Rochester, MN
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).
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A Study of Personalized Molecular Markers to Transform Treatment of High Grade Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.
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Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
Jacksonville, FL
The purpose of this study is to provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy). In addition, long-term safety and overall survival will be collected.
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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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Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.
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Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
Jacksonville, FL
The goal of this clinical research study is to learn if BL-8040 in combination with cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia (AML) that has relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
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A Study to Provide Expanded Access for the Treatment of Cancers with Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of AMG 397 in Subjects With Multiple Myeloma, NHL, and AML
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AMG 397 by estimating the maximum tolerated doses (MTDs) and/or biologically active doses.
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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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Using Social Media for Public Health Education on Melanoma within the Hispanic Population
Scottsdale/Phoenix, AZ
The purpose of this study is to develop online education video-based modules to educate the Hispanic community. This will allow for the widespread, cost-effective scaling of our educational platform. Also, to demonstrate improvement in knowledge and practice of sun-smart behaviors. We will achieve this goal through a baseline, three-month, and one-year follow-up questionnaire examining melanoma knowledge and sun-safe behaviors (sunscreen use, sun protective clothing use, self-skin examination). Understanding the risks of melanoma and actively reducing one's risk of melanoma will be key to reducing the incidence of melanoma and improving overall survival in this population.
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Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
No Locations
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
TP-0903 is a novel oral inhibitor that targets AXL kinase. Preclinical studies have shown promising antitumor activity of TP-0903 as a single agent against a variety of tumor types in both in vitro and in vivo studies. This first-in-human study is conducted to identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TP-0903 administered orally to patients with advanced solid tumors. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity profiles.
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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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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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Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology
Rochester, MN
The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
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Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
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Cognitive Function After Treatment of Primary CNS Malignancy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate cognitive function and to determine neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent.
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Study to Evaluate the Safety and Effectiveness of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes in Women with Breast Cancer Using Magseed Markers as an Alternative to the Current Practice of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
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A Study of Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma
Rochester, MN
The main purpose of this study is to assess the effectiveness and safety of treatment with anetumab ravtansine versus vinorelbine for progression free survival in patients with stage IV mesothelin overexpressing type of malignant pleural mesothelioma. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
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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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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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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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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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Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma
Jacksonville, FL; Rochester, MN
This study is evaluating whether administration of glucarpidase will allow faster clearance of high-dose methotrexate and thus fewer side effects related to methotrexate therapy.
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A Study to Evaluate TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the safety and effectiveness of TAK-981 in combination with anti-CD38 monoclonal antibodies. TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.
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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 Determine the Effectiveness and Safety of Luspatercept in Patients with Myelodysplastic/ Myeloproliferative Neoplasms with Ring Sideroblasts and Thrombocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. ...
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Colorectal Cancer and Peripheral Neuropathy Study
Jacksonville, FL
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
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Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
No Locations
The purpose of this study is:
- To assess whether a team based care model applied to distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
- To assess whether health promotion tools such as psychoeducation applied to non-distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
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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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Study of Lenzilumab (KB003) in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
Rochester, MN
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
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A Study of the Safety, Tolerability, Drug/Body Interactions, Biological and Clinical Activity of MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, drug/body interactions, and the biological and clinical activities of MSB0011359C (M7824) at different dose levels given to patients who have metastatic or locally advanced solid tumors.
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A Study to Assess LXH254 in Patients with Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma
Rochester, MN
The purpose of this study is to evaluate combinations, using LXH254 as a backbone, which may help overcome intrinsic and acquired resistance to BRAF targeted therapy as well as offer new treatment options for NRAS melanoma patients.
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Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
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Evaluate REC-4881 in Patients With FAP (TUPELO)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
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A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Study to Improve health-related quality of life (HRQOL) in Black Prostate Cancer Patients (CaPQoL) through Whole Person Survivorship Care
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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Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
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, 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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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Rochester, MN
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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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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Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Rochester, MN
The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
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A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ
This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.
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Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Rochester, MN
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma
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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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A First-in-Human Phase 1 and Expanded Cohort Study of EPZ-5676 in Advanced Hematologic Malignancies, Including Acute Leukemia With Rearrangement of the MLL Gene
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene.
Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD).
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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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Rem-422, an MYB mRNA Degrader, in Patients With Relapsed/Refractory AML or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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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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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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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 Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
No Locations
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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Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. Once the maximum tolerated dose (MTD) or ...
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A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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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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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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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 Assess the Effectiveness and Safety of UGN-102 as a Primary Chemoablation Agent in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (LG NMIBC) at Intermediate Risk of Recurrence
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.
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A Study of ONO-7475 in Patients With Acute Leukemias
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes, and to assess the safety, tolerability, and preliminary effectiveness of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.
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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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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of Selpercatinib, compared to a standard treatment, in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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A Study of TAS-120 in Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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A Study to Investigate Blood-derived Circulating Tumor DNA, Circulating Tumor RNA, and Circulating Tumor miRNA in Pancreatic Cancer Patients
Jacksonville, FL
The purpose of this study is to establish a cohort of 200 patients receiving definitive radiotherapy at Mayo Clinic Florida for locally advanced pancreatic cancer (T3-4NxM0; TxN+M0), and establish a biobank of 10 ml of plasma (frozen at –80o C) for each patient at baseline (prior to starting radiation treatment), week 2 of radiation treatment and 4-8 weeks following radiation treatment.
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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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P1101 in Treating Patients With Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
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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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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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RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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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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A Study of APG-2575 Alone or in Combination with Other Therapeutic Agents to Treat Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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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 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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A Dose Escalation Study of Amivantamab in Participants with Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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Addressing Breast Cancer Equity
Jacksonville, FL
The purpose of this study is to test if a culturally tailored virtual navigation program (Second-Life) meet the needs of Black women in learning more about breast health and care for cancer prevention, and mammography screening. We are asking for feedback on the Second-Life experience to determine if the information is easy to understand, relevant, and valuable to the community. The goal is to develop virtual community navigation that helps Black women make informed decisions about their breast healthcare since Black women have high mortality rates from breast cancer compared to other races or ethnicities.
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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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A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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A Study of Circulating Tumor DNA as a Biomarker of a Complete Response of Disease for Advanced Gastroesophageal Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate circulating tumor DNA as a potential biomarker for pre-surgery treatment response in patients who have esophageal cancer.
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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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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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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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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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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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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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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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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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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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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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Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors.
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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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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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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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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 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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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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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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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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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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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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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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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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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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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 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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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 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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A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors (SPX-303)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / 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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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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Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
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, 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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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Rochester, MN
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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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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Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Rochester, MN
The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
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A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ
This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.
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Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Rochester, MN
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma
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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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A First-in-Human Phase 1 and Expanded Cohort Study of EPZ-5676 in Advanced Hematologic Malignancies, Including Acute Leukemia With Rearrangement of the MLL Gene
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene.
Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD).
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A Study of ONO-7475 in Patients With Acute Leukemias
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes, and to assess the safety, tolerability, and preliminary effectiveness of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.
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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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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of Selpercatinib, compared to a standard treatment, in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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A Study of TAS-120 in Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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A Study to Investigate Blood-derived Circulating Tumor DNA, Circulating Tumor RNA, and Circulating Tumor miRNA in Pancreatic Cancer Patients
Jacksonville, FL
The purpose of this study is to establish a cohort of 200 patients receiving definitive radiotherapy at Mayo Clinic Florida for locally advanced pancreatic cancer (T3-4NxM0; TxN+M0), and establish a biobank of 10 ml of plasma (frozen at –80o C) for each patient at baseline (prior to starting radiation treatment), week 2 of radiation treatment and 4-8 weeks following radiation treatment.
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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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Rem-422, an MYB mRNA Degrader, in Patients With Relapsed/Refractory AML or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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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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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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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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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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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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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 Assess the Effectiveness and Safety of UGN-102 as a Primary Chemoablation Agent in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (LG NMIBC) at Intermediate Risk of Recurrence
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Rochester, MN
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
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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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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 Study of APG-2575 Alone or in Combination with Other Therapeutic Agents to Treat Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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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 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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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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A Dose Escalation Study of Amivantamab in Participants with Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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Addressing Breast Cancer Equity
Jacksonville, FL
The purpose of this study is to test if a culturally tailored virtual navigation program (Second-Life) meet the needs of Black women in learning more about breast health and care for cancer prevention, and mammography screening. We are asking for feedback on the Second-Life experience to determine if the information is easy to understand, relevant, and valuable to the community. The goal is to develop virtual community navigation that helps Black women make informed decisions about their breast healthcare since Black women have high mortality rates from breast cancer compared to other races or ethnicities.
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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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A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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P1101 in Treating Patients With Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
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A Study of Circulating Tumor DNA as a Biomarker of a Complete Response of Disease for Advanced Gastroesophageal Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate circulating tumor DNA as a potential biomarker for pre-surgery treatment response in patients who have esophageal cancer.
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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 of WVT078 in Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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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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A Study of Effect of Different Biochemical Markers including Leptin and Spexin in Children Before and After Having Hypothalamus Surgery
Rochester, MN
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
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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 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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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 Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors
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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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 3 Study of 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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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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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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Pediatric Extracranial Solid Tumor Biorepository
Rochester, MN
The purpose of this study is to create a biospecimen repository for both fresh frozen tissue from core needle biopsies and tumor resections as well as serial plasma collection.
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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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Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
Jacksonville, FL
The objective of this pilot stdy is to plan, develop and establish the acceptance and usability of a Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot Assistant (ViRA).
The specific aims of this study are to plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research, and to establish the acceptance and usability of the iCCaRE ViRA at a urology clinic among 50 Black men (BM).
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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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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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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 Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients.
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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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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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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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A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, MN
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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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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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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Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Rochester, MN
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma
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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
No Locations
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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Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. Once the maximum tolerated dose (MTD) or ...
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A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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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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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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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 Assess the Effectiveness and Safety of UGN-102 as a Primary Chemoablation Agent in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (LG NMIBC) at Intermediate Risk of Recurrence
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.
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A Study of ONO-7475 in Patients With Acute Leukemias
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes, and to assess the safety, tolerability, and preliminary effectiveness of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.
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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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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of Selpercatinib, compared to a standard treatment, in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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A Study of TAS-120 in Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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A Study to Investigate Blood-derived Circulating Tumor DNA, Circulating Tumor RNA, and Circulating Tumor miRNA in Pancreatic Cancer Patients
Jacksonville, FL
The purpose of this study is to establish a cohort of 200 patients receiving definitive radiotherapy at Mayo Clinic Florida for locally advanced pancreatic cancer (T3-4NxM0; TxN+M0), and establish a biobank of 10 ml of plasma (frozen at –80o C) for each patient at baseline (prior to starting radiation treatment), week 2 of radiation treatment and 4-8 weeks following radiation treatment.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
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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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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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RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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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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A Study of APG-2575 Alone or in Combination with Other Therapeutic Agents to Treat Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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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 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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A Dose Escalation Study of Amivantamab in Participants with Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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Addressing Breast Cancer Equity
Jacksonville, FL
The purpose of this study is to test if a culturally tailored virtual navigation program (Second-Life) meet the needs of Black women in learning more about breast health and care for cancer prevention, and mammography screening. We are asking for feedback on the Second-Life experience to determine if the information is easy to understand, relevant, and valuable to the community. The goal is to develop virtual community navigation that helps Black women make informed decisions about their breast healthcare since Black women have high mortality rates from breast cancer compared to other races or ethnicities.
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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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A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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A Study of Circulating Tumor DNA as a Biomarker of a Complete Response of Disease for Advanced Gastroesophageal Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate circulating tumor DNA as a potential biomarker for pre-surgery treatment response in patients who have esophageal cancer.
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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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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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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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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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P1101 in Treating Patients With Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Rochester, MN
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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A Study of WVT078 in Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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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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A Study of Effect of Different Biochemical Markers including Leptin and Spexin in Children Before and After Having Hypothalamus Surgery
Rochester, MN
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
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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 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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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 Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors
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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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 3 Study of 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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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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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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Pediatric Extracranial Solid Tumor Biorepository
Rochester, MN
The purpose of this study is to create a biospecimen repository for both fresh frozen tissue from core needle biopsies and tumor resections as well as serial plasma collection.
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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 Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients.
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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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A First-in-Human Phase 1 and Expanded Cohort Study of EPZ-5676 in Advanced Hematologic Malignancies, Including Acute Leukemia With Rearrangement of the MLL Gene
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene.
Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD).
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Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Rochester, MN
The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
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A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ
This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.
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Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Rochester, MN
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma
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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
No Locations
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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Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. Once the maximum tolerated dose (MTD) or ...
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A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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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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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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A Study of ONO-7475 in Patients With Acute Leukemias
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes, and to assess the safety, tolerability, and preliminary effectiveness of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.
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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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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of Selpercatinib, compared to a standard treatment, in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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A Study of TAS-120 in Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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A Study to Investigate Blood-derived Circulating Tumor DNA, Circulating Tumor RNA, and Circulating Tumor miRNA in Pancreatic Cancer Patients
Jacksonville, FL
The purpose of this study is to establish a cohort of 200 patients receiving definitive radiotherapy at Mayo Clinic Florida for locally advanced pancreatic cancer (T3-4NxM0; TxN+M0), and establish a biobank of 10 ml of plasma (frozen at –80o C) for each patient at baseline (prior to starting radiation treatment), week 2 of radiation treatment and 4-8 weeks following radiation treatment.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
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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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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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RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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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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A Study of APG-2575 Alone or in Combination with Other Therapeutic Agents to Treat Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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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 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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A Dose Escalation Study of Amivantamab in Participants with Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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Addressing Breast Cancer Equity
Jacksonville, FL
The purpose of this study is to test if a culturally tailored virtual navigation program (Second-Life) meet the needs of Black women in learning more about breast health and care for cancer prevention, and mammography screening. We are asking for feedback on the Second-Life experience to determine if the information is easy to understand, relevant, and valuable to the community. The goal is to develop virtual community navigation that helps Black women make informed decisions about their breast healthcare since Black women have high mortality rates from breast cancer compared to other races or ethnicities.
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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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A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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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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Rem-422, an MYB mRNA Degrader, in Patients With Relapsed/Refractory AML or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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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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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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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 Study of Circulating Tumor DNA as a Biomarker of a Complete Response of Disease for Advanced Gastroesophageal Adenocarcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate circulating tumor DNA as a potential biomarker for pre-surgery treatment response in patients who have esophageal cancer.
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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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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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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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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 Assess the Effectiveness and Safety of UGN-102 as a Primary Chemoablation Agent in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (LG NMIBC) at Intermediate Risk of Recurrence
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.
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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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P1101 in Treating Patients With Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Rochester, MN
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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A Study of WVT078 in Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors
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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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 3 Study of 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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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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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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Pediatric Extracranial Solid Tumor Biorepository
Rochester, MN
The purpose of this study is to create a biospecimen repository for both fresh frozen tissue from core needle biopsies and tumor resections as well as serial plasma collection.
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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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Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
Jacksonville, FL
The objective of this pilot stdy is to plan, develop and establish the acceptance and usability of a Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot Assistant (ViRA).
The specific aims of this study are to plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research, and to establish the acceptance and usability of the iCCaRE ViRA at a urology clinic among 50 Black men (BM).
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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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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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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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A Study to Assess the Antitumor Activity and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 Positive, Metastatic Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM.
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A Study to Develop Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality
Jacksonville, FL
The purpose of this study is to reduce disparities in endometrial cancer (EC) mortality among African American women (AAW) by developing an understanding of what may be needed to increase awareness of signs of EC and advance efforts to introduce early detection of EC using a novel tampon based test.
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A Pilot Study to Evaluate the Molecular and Biological Phenotype of Peripheral Immune Cells in Solid Tumor Patients
Rochester, MN
The purpose of this study is to investigate for potential mechanisms underlying the sensitivity and resistance to immune checkpoint modulating agents that lead to the identification of sensitivity/resistance biomarkers and development of novel immunotherapeutic approaches.
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Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
Scottsdale/Phoenix, AZ; Rochester, MN
This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.
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MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Scottsdale/Phoenix, AZ
The primary purpose of this study for Step 1:
- To determine the RP2D of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
The primary purpose of this study for Step 2:
- To assess the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
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A Study to Evaluate the Effectiveness and Safety of rAd-IFN Administered With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.
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A Patient Access Program of Olaratumab for the Continued Treatment of Soft Tissue Sarcoma
Jacksonville, FL
The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).
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A Follow-Up Study of Subjects Treated With ACTR T Cell Product
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to follow subjects who were treated with ACTR after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
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Neuro-Oncology Care Priorities of Patients and Caregivers
Rochester, MN
The purpose of this study is to conduct semi-structured interviews with patients who have primary and metastatic CNS tumors as well as caregivers of these patients.
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A Phase I Study of TAS-102 in Patients with Advanced Solid Tumors with Renal Impairment
Scottsdale/Phoenix, AZ
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.
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Study of Safety and Tolerability of VLX600, an Iron Chelator, in Patients with Refractory Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors.
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MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery
Rochester, MN
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
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GEN3013, Epcoritamab Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™ NHL-1
Scottsdale/Phoenix, AZ
The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.
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A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
Rochester, MN
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.
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Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients
Rochester, MN
The small molecule, CWP232291, by binding Sam68 promotes apoptosis in selective cancer cells through 1)induction of the TNF-α apoptotic pathway, 2)alternative splicing, tipping the balance towards pro-apoptotic as opposed to anti-apoptotic isoforms, and 3)inhibition of the anti-apoptotic Wnt driven gene, survivin
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A Study of DFRF4539A in Patients with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL
This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
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Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Study to Evaluate the Safety and Effectiveness of TT-00420 in Adults with Advanced Cholangiocarcinoma
Rochester, MN
The purpose of this trial is to evaluate the effectiveness and safety of TT-00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment and discontinued due to disease progression, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
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A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML
Rochester, MN
The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory AML after treatment with standard therapy.
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Management of Locoregional Recurrent Breast Cancer
Rochester, MN
The aims of this study are to develop an institutional recurrent breast cancer registry, including prior and future patients, which will be prospectively maintained to characterize the current management of patients with locally recurrent breast cancer. Specifically, investigate the extent of operation, subsequent operations, use of radiation and re-radiation and timing and nature of systemic therapies and variables associated with selection of these modalities, and to analyze breast-cancer specific outcomes including rates of local re-recurrence, regional and distant recurrence, recurrence-free and breast-cancer specific survival.
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Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
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Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue
Rochester, MN
The purpose of this study is to test the effectiveness of a remote monitoring program with health coaching for patients with cancer related fatigue.
The primary objective is to assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory and the Cancer Fatigue Scale/ MFSI-SF. Secondary objective is to assess the effect of the program on quality of life by administering the LASA questionnaire.
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Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Rochester, MN
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.
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Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Rochester, MN
This pilot clinical trial studies how well buparlisib works in treating patients with non-Hodgkin lymphoma that has returned or does not respond to treatment. Buparlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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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, medications, and dosing information.
The primary goal of the Data Hub is to further the scientific knowledge base for the diagnosis, understanding, and management of benign and malignant hematologic conditions by assembling data collected in routine clinical care and closed clinical trials. Secondary goals are to characterize and study practice patterns for benign and malignant hematologic conditions in clinical practice, and to aggregate patient-reported data to ...
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Brain Tumor-Gut Axis Human Biorepository
Jacksonville, FL
The purpose of this study is to establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.
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Minority-inclusive Imaging Biomarker-based End of Therapy Trial for 177Lu-PSMA-617
Rochester, MN
The MI-BET trial is an investigation designed to improve the utilization of 177Lutetium PSMA-617 (177Lu PSMA-617) in metastatic castrate resistant prostate cancer.
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An Open Label Extension Study of BMS-911543 In Subjects With Myelofibrosis
Rochester, MN
The purpose of this study is to provide patients with myleofibrosis (MF) who participated in study CA215001 access to BMS-911543.
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A Phase I/II Study of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Advanced Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of AZD0466 as monotherapy or in combination with other anticancer agents in patients with advanced Non-Hodgkin Lymphoma (NHL).
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Appointment Companion Tool
Rochester, MN
The purpose of this study is to pilot the patient appointment companion (PAC) tool in use with patients with amyloidosis and multiple myeloma (MM). Patients with hematologic malignancies have unique information and communication needs compared to those with solid tumors. The internet has shifted the dynamics of the patient–doctor relationship, toward one of more mutual participation whereby power and responsibility are shared. The PAC was designed as a patient-centered, user-friendly platform that aids patients’ preparation for their visits with clinicians. PAC provides an online tool that empowers patients to direct their treatment preferences and care alongside their physician teams per the provisions ...
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A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
Rochester, MN
Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.
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Study to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the effectiveness, safety and drug/body interactions of EDO-S101 in patients with relapsed or resistant hematologic cancers.
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A Phase 2, Multicenter, Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label
Rochester, MN
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.
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Trastuzumab Emtansine in Treating Older Patients With Human Epidermal Growth Factor Receptor 2-Positive Stage I-III Breast Cancer
Rochester, MN
This phase II trial studies how well trastuzumab emtansine works in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer. HER2 is a protein found on the surface of cancer cells that helps them to grow and spread. Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of the tumor cells and blocking their ability grow and spread.
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PLX3397 Phase 3 Study for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug PLX3397 in the treatment of tumour of pigmented villonodular synovitis or giant cell tumor of the tendon sheath in subjects, for whom surgical removal of the tumour would cause more harm than good. The main purpose of this study is to gather information about the investigational drug PLX3397, which may help to treat these tumours. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either PLX3397 or matching placebo for 24 weeks. A number of ...
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Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other Myelodysplastic /Myeloproliferative Neoplasias, and Acute Myeloid Leukemia
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment until disease progression. If a complete response is observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start of response.
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Recruitment to Promote Cancer Health Equity Across Florida
Jacksonville, FL
The purpose of this study is to qualitatively examine, via individual and group interviews, a tailored intervention utilizing virtual human technology 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. Virtual human technology uses computerized agents with a human-like body and naturalistic dialogue to deliver educational information and model behaviors. Virtual human technology is used in a variety of health contexts and has the potential to increase the diversity of NCI-sponsored clinical trials by reducing common barriers to NCI-sponsored clinical ...
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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorder
Rochester, MN
The purpose of this Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for ...
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A Study of the Safety and Effectiveness of TH-302 Combined with Gemcitabine and Compared with Gemcitabine Alone for Previously Untreated Patients with Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if TH-302 combined with Gemcitabine versus Gemcitabine alone is as safe and effective in the treatment of patients who have first-line metastatic pancreatic adenocarcinoma.
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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 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 of the Expression and Frequency of Tissue Biomarker Mutations in Breast Cancer that is Resistant or Refractory to Treatment with Trastuzumab and/or Pertuzumab
No Locations
The purpose of this study is to measure the expression and frequency of the tumor tissue biomarkers (the genetics) of breast cancer, specifically the decreased presence and amount of a specific protein (Human epidermal growth factor receptor-2 [HER2]), how often genetic mutations occur, and why the cancer might or might not respond to monoclonal antibody therapy, such as trastuzumab emtansine (T-DM1) and/or pertuzumab.
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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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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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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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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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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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Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Rochester, MN
The purpose of this trial is to study the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
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Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.
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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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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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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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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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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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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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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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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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A Study of Prostate Cancer Care and Survivorship Among Sub-Saharan African Immigrant Impacted by Social Determinants of Migrant Health Factors
Rochester, MN
The primary objective of this study is to employ the social determinant of migrant health framework (International Organization for Migration, n.d.) to examine the impact of immigration on the health-seeking behaviors of Sub-Saharan African Immigrant (SSAI) and Caribbean Immigrant (CI) men including informed-decision making, psychosocial effects and coping mechanisms.
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A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the safety, pharmacokinetics, preliminary anticancer activity, and RP2R(s) of the study treatment in adult participants ≥ 18 years of age with multiple myeloma that is relapsed or refractory to established therapies or who are intolerant of established therapies. The study will be conducted in 3 parts.
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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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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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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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A Study to Evaluate Hemorrhage and Thrombosis in Hematology Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to determine: the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia, and recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.
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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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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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A Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics (PK/PD) in Patients With Hematologic Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.
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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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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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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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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)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede patients’ access to appropriate care.
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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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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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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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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 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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Broad Evidence of Systemic Immune Activation in Long Term Survivors of Advanced Ovarian Cancer
Jacksonville, FL; 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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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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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 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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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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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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Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the effectiveness of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).
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MicroOrganoSphere Drug Screen Pilot Trial in Colorectal Cancer (CRC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14="">
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
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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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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
No Locations
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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Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
No Locations
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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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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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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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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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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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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A Study of Ramucirumab Plus Docetaxel in Patients With Urothelial Cancer
Rochester, MN
The main purpose of this study is to evaluate the safety and effectiveness of the study drug ramucirumab in combination with docetaxel in patients with urothelial cancer who failed prior platinum-based therapy.
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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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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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Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Jacksonville, FL
This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, 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. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.
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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 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 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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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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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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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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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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A Study to Assess Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients with Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
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A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients with Gastrointestinal Stromal Tumour After Progression with Imatinib
Jacksonville, FL; Rochester, MN
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day
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Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II/III trial studies how well giving azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with ...
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Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Jacksonville, FL; Rochester, MN
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
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Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)
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IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
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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 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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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Jacksonville, FL; Rochester, MN
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: 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 or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ...
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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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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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A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
Jacksonville, FL
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.
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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 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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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 Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer Using Patient-Centered Home Care
Jacksonville, FL
The purpose of this study is to evaluate a highly innovative project evaluating the feasibility of patient-centered home care (PCHC) as a new model of cancer care to reduce disparities and improve health related qualtiy of life (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP).
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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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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 to Evaluate Accelerated Resolution Therapy in Cancer and Palliative Care
Jacksonville, FL
The following research questions will guide this study: 1) Is ART feasible and acceptable for use with distressed patients and/or family caregivers in oncology and palliative care clinical settings? 2) What is the mean dose of ART provided to distressed patients and/or family caregivers? 3) What are the patient and family stressors that result in a recommendation for ART? 4) Does ART reduce symptoms of psychological trauma, anxiety and depression, when used with distressed patients and family caregivers in oncology and palliative care clinical settings? 5) Does ART improve resilience when used with distressed ...
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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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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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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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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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A Study of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma
Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed MM. To determine the overall response rate with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma.
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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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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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Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Scottsdale/Phoenix, AZ; Rochester, MN
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in each arm. ...
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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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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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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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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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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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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 Evaluate EAA181 to Treat Newly-diagnosed Multiple Myeloma
La Crosse, WI; Rochester, MN
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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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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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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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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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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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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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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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 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 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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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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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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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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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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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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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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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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Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Jacksonville, FL
This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, 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. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.
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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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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
No Locations
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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Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
No Locations
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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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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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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A Study of Ramucirumab Plus Docetaxel in Patients With Urothelial Cancer
Rochester, MN
The main purpose of this study is to evaluate the safety and effectiveness of the study drug ramucirumab in combination with docetaxel in patients with urothelial cancer who failed prior platinum-based therapy.
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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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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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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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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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A Study to Assess Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients with Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
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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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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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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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Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
Scottsdale/Phoenix, AZ
This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
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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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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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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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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 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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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Rochester, MN
The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
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Phase I Study of LB-100 With Docetaxel in Solid Tumors
Rochester, MN
The purpose of this study is to test the safety of an investigational drug called LB 100 for Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer (chemotherapeutic agents). Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will receive injections of LB-100. ...
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Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts.
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A Study to Evaluate Cryotherapy to Prevent Taxane-induced Sensory Neuropathy of the Hands and Feet
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and tolerability of cryotherapy (cold therapy) in the form of Elasto Gel® frozen mittens and foot wraps to determine whether or not they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. The hypothesis of our pilot study is that patients receiving cryotherapy during infusion of taxane therapy will have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
Rochester, MN
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the ...
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Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to ...
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A Study to Evaluate Trabectedin with Olaparib in Advanced Unresectable or Metastatic Sarcoma
Rochester, MN
The purpose of this study is to evaluate how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body.
Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
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A Study to Evaluate Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
Rochester, MN; Mankato, MN; Eau Claire, WI
The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
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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 Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to look at the effectiveness and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
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Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Jacksonville, FL
The purpose of this study is to evaluate GDA-201, an allogeneic cryopreserved NK cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
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Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
Jacksonville, FL
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves overall response rate (ORR) by Cycle 6 and whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
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Incidence of Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to determine the percentage of patients receiving cancer-directed therapy at the Gonda 10 chemotherapy unit who have had or are currently experiencing symptoms of nasal vestibulitis.
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A Study to Evaluate the Effectiveness and Safety of Panzyga in Patients with Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia (CLL) patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.
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A Study to Evaluate IMGN632 with Venetoclax and/or Azacitidine to Treat Patients with CD123-Positive Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is is to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.
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Grief Among Older Adult Family Caregivers
Jacksonville, FL
The purpose of this study is to evaluate the trajectory of loss and grief over 12 months, the risk factors associated with high levels of pre-loss grief, and the preliminary effectiveness of ART for treatment of high levels of pre-loss grief among family caregivers (FCG) of persons nearing the end of life.
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Ascorbic Acid and Combination Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma or CCUS
Rochester, MN; La Crosse, WI; Eau Claire, WI; Mankato, MN
The purpose of this study is to examine how well ascorbic acid and combination chemotherapy work in treating patients with lymphoma that has come back or does not respond to therapy. Ascorbic acid may make cancer cells more sensitive to chemotherapy. 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 ascorbic acid and combination chemotherapy may work better at treating lymphoma.
In the Clonal Cytopenia of Undetermined Significance (CCUS) Cohort D, we want to find out if ascorbic acid will ...
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CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the number of new biopsy confirmed Basal Cell Carcionomas (BCCs) that
develop on the face over a 6-month period between the treatment arms, active and placebo.
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A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Jacksonville, FL
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
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Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
Scottsdale/Phoenix, AZ
The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer. The safety of this drug combination will also be studied.
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A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the antitumor activity of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced solid tumors including:
- Cohort A: Colorectal cancer (CRC);
- Cohort B: Gastric and gastroesophageal junction (GEJ) cancer;
- Cohort C: Triple-negative breast cancer (TNBC);
- Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer).
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PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
Eau Claire, WI; Rochester, MN
The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.
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A Study of Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
Rochester, MN
The purpose of this study is to evaluate how well daunorubicin and cytarabine, with or without uproleselan, works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin 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. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.
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Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
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A Study to Investigate the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Jacksonville, FL; Rochester, MN
The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.
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Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
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Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Rochester, MN
The purpose of this study is to assess the safety, tolerability, and bioactivity of escalating doses of AAVAnc80-antiVEGF administered via unilateral intracochlear administration (using the investigational delivery device as part of a delivery system).
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A Study to Evaluate DS-8201a Combined with Olaparib in HER2-Expressing Cancers with Expansion in Endometrial Cancer Patients
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of the combination of DS-8201a in combination with olaparib, and to determine the recommended phase 2 dose (RP2D) 1.1.2 To evaluate the safety and tolerability of this combination in a dose expansion cohort in patients with uterine serous carcinoma.
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Gemini Study to Evaluate the Integration of Cancer Genetic Testing into a Cancer Clinical Practice at Mayo Clinic at Arizona
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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Testing Whether The Addition Of Carboplatin Chemotherapy To Cabazitaxel Chemotherapy Will Improve Outcomes Compared To Cabazitaxel Alone In People With Castrate-Resistant Prostate Cancer That Has Spread Beyond The Prostate To Other Parts Of The Body
La Crosse, WI
The purpose of this study compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of ...
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Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
No Locations
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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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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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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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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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 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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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 of Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia
No Locations
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 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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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
No Locations
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 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 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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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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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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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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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 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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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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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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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
No Locations
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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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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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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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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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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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
No Locations
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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Centered Psychotherapy for Caregivers of Patients With Advanced Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study to determine feasibility, acceptability, and assess preliminary effects of a virtual group MCP-C on 30 of caregivers of patients with advanced cancer. Meaning-Centered Group Psychotherapy for Cancer Caregivers MCP-C is a 8-session individual intervention that utilizes didactics, discussion, and experiential exercises that focus on themes related to meaning and caregiving.
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Genetic Testing with Family History of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. A subset of 40 patients, who did not have appropriate NCCN intervention (the opportunity to have a genetic consultation to consider genetic testing) will prospectively be offered this opportunity. This subset of patients will also be surveyed on their family hisotry and knowledge and experiences of genetic consults/testing to better understand their decision-making when offered genetic counseling and testing.
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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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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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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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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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Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-based Classifier in Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
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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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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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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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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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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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
No Locations
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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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
No Locations
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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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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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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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 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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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 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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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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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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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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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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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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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 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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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 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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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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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 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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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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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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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 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 to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer
No Locations
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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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 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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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 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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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 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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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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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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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 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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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 of Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia
No Locations
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 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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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
No Locations
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 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 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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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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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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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
No Locations
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 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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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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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 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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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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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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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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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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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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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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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 to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.
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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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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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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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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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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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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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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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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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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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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
No Locations
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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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
No Locations
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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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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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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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 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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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 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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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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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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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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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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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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Durvalumab+/- Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
No Locations
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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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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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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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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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 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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Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
No Locations
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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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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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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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.
-
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.
-
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.
-
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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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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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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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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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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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
No Locations
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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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 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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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 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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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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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 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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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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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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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 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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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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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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A Study to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer
No Locations
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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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 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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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 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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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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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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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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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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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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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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A Study to Evaluate Reiki Therapy as an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting
Rochester, MN
The primary purpose of this study is to evaluate the feasibility of offering and providing Reiki Therapy in hospitalized hematology/oncology cancer patients.
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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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Brentuximab Vedotin and Combination Chemotherapy in Treating Younger Patients with Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, 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. It is not yet known if combination ...
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Phase 3 Study to Treat Patients with Soft Tissue Sarcomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
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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 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 to Evaluate Magnetic Resonance Spectroscopy Diagnosis and Follow-up of IDH-mutant Glioma
Rochester, MN
The purpose of this study is to develop an MRS-based measurement of 2-HG that is reliable, and to assess the reproducibility of the method(s) above on a cohort of patients with IDH mutant low grade gliomas.
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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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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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Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
Rochester, MN
The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
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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 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 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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Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
No Locations
This laboratory study is looking at genetic mutations and environmental exposure in young patients with retinoblastoma and in their parents and young healthy unrelated volunteers. Gathering information about gene mutations and environmental exposure may help doctors learn more about the causes of retinoblastoma in young patients.
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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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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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Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
Rochester, MN
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer 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 them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
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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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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 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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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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Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Rochester, MN
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
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A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
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 determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
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A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma
Rochester, MN
This phase III trial compares the effect of vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide for the treatment of high risk rhabdomyosarcoma. Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, 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 vinorelbine and VAC may kill more tumor cells. Adding maintenance therapy (vinorelbine and cyclophosphamide) after VAC therapy, with or without vinorelbine, may help get rid of the cancer and/or ...
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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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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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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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Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary Cancer and Changes in Gut Microbiome
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is investigate if functions and composition of the gut microbiome are associated with the occurrence of chemotherapy-induced nausea (CIN). Also, to evaluate the feasibility of patient recruitment and retention, as well as specimen collection and to evaluate for changes in alpha and beta diversity as well as composition (i.e. relative abundance) of the gut microbiome from T1 to T2 in patients who do and do not report CIN at T2. In addition, to examine associations between microbial composition functional profiles at T1 and T2 in patients who report CIN at T2.
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ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma.
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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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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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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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Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE - Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. - Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). - No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and ...
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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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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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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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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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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 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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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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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 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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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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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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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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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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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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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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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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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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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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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 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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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”
Eau Claire, WI; Scottsdale/Phoenix, AZ; 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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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 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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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 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; Jacksonville, FL; Rochester, MN
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 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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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
No Locations
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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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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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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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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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 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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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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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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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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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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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
No Locations
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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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 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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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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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 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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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 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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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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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 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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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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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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A Study to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer
No Locations
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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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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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 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 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 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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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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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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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 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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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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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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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 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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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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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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177Lu-DTPA-Omburtamab Radioimmunotherapy toTreat Recurrent or Refractory Medulloblastoma
No Locations
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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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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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 Study of the Combination of IMCgp100 with Durvalumab and/or Tremelimumab for Patients with Advanced Cutaneous Melanoma
No Locations
The purpose of this study is to characterize the safety, tolerability, effectiveness, biological activity, and drug/body interactions of IMCgp100, alone and in combination with durvalumab (MEDI4736) and/or tremelimumab for the treatment of patients who have advanced metastatic cutaneous melanoma.
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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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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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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)
No Locations
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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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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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 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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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 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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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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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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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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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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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
No Locations
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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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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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 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 to Evaluate Exercise for Cancer Patients at Risk of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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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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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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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 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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Study of Pembrolizumab With Ipilimumab or Placebo in Participants with Untreated Metastatic Non-small Cell Lung Cancer
No Locations
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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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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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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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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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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Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancer types are: Non-Small Cell Lung Cancer (NSCLC) and melanoma that are progressing on checkpoint inhibitor (CPI, generally refers to anti-PD(L)1 antibodies) treatment, CPI-naïve hepatocellular carcinoma (HCC), and treatment-naïve endometrioid endometrial cancer.
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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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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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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 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 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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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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Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet), and nivolumab + bempegaldesleukin (triplet) in subjects with advanced solid tumors, as well as evaluate the safety and effectiveness of XL092 as combination therapy in tumor-specific Expansion Cohorts, which will enroll subjects with genitourinary cancers.
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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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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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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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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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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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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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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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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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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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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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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
No Locations
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 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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A Study to Evaluate the Epidemiology of Estrogen Genotoxicity in Breast Cancer
Rochester, MN
The purpose of this study is to recruit 2000 incident cases of primary breast cancer in order to perform laboratory assays to measure frequencies of genetic polymorphisms for genes that encode enzymes involved in candidate gene pathways, including: estrogen and catecholestrogen formation, bioactivation and inactivation, cellular proliferation and apoptosis, nuclear factor kappa-beta; to compare genotype frequencies for polymorphisms of genes in breast cancer cases and controls, and to evaluate possible interactions among common polymorphisms in candidate genes.
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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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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 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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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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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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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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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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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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VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small cell lung cancer. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.
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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 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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MC200404, Safety and Immunogenicity of PolyPEPI1018 Vaccine in the Treatment of Late-stage Metastatic Colorectal Cancer
Rochester, MN
The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.
PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.
Participants will receive TAS-102 and PolyPEPI1018 which ...
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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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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 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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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 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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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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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 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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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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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 Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients with Recurrent Glioblastoma with Elevated Mutational Burden
Scottsdale/Phoenix, AZ; Rochester, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI
The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma ...
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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 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 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 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 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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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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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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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 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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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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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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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 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 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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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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Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet), and nivolumab + bempegaldesleukin (triplet) in subjects with advanced solid tumors, as well as evaluate the safety and effectiveness of XL092 as combination therapy in tumor-specific Expansion Cohorts, which will enroll subjects with genitourinary cancers.
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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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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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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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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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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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Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to is to evaluate patients with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.
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A Study of MicroRNAs in Patients with Multiple Myeloma Treaded with Immunomodulatory Drugs
Scottsdale/Phoenix, AZ
The purpose of this study is to explore how IMiD treatments affect certain genetic material called (microRNAs) in the body of patients with multiple myeloma.
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A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be randomized 1:1 to receive one of the following treatment regimens during induction phase:- -Arm A: Tiragolumab plus atezolizumab and CE -Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
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A Study to Measure the Proteins Expressed in tissue Samples from Women who have been Treated with New Endocrine Therapy for Invasive Lobular Breast Cancer
Rochester, MN
The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.
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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
No Locations
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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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
Rochester, MN
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 the Effectiveness and Safety of Pembrolizumab Combined with Bacillus Calmette-Guerin in High-Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.
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A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Scottsdale/Phoenix, AZ
The purpose of this study is to compare ipilimumab with and without IMO-2125 in advanced melanoma patients.
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A Study to Evaluate the Safety and Effectiveness of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma Patients
Rochester, MN; Jacksonville, FL
The purpose of this 2-part study is to evaluate the safety and effectiveness of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of ...
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A Study of the Safety and Effectiveness of Atezolizumab Combined with Etoposide, and Carboplatin for Patients with Untreated Extensive-Stage Small Cell Lung Cancer
Rochester, MN
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death ligand 1 [anti-PD-L1]) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in treatment-naive participants with extensive-stage small cell lung cancer (ES-SCLC). Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21 day-cycles for 4 cycles in the induction phase followed by maintenance with atezolizumab or placebo until disease progression (PD) as assessed by the investigator using Response Evaluation ...
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A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Rochester, MN
This is a study of pembrolizumab for advanced gastric or gastroesophageal junction adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as combination therapy with cisplatin and 5-Fluorouracil (5-FU) in treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful overall response rate.
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Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia or Lobular Carcinoma In Situ
Rochester, MN
The purpose of this study is to analyze breast tissue changes after a short course of Tamoxifen (Tam).
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A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Rochester, MN
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma
No Locations
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
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Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
Rochester, MN
This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an intra-patient dose escalation paradigm based on ...
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Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
No Locations
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...
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Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
Rochester, MN
The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.
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Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma subjects.
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Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, 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 and avelumab together may further shrink the cancer or prevent it from returning/progressing.
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Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (PROTA)
Rochester, MN
The purpose of this study is to evaluate the safety [including dose-limiting toxicities (DLTs)] of the combination therapy of TILT-123 and pembrolizumab in patients with platinum resistant or refractory ovarian cancer.
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Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well nivolumab, with or without ipilimumab, works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic).
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A Study to Determine the Outcomes of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy
Rochester, MN
AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).
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Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Albert Lea, MN; Eau Claire, WI; Mankato, MN; Jacksonville, FL; Rochester, MN; La Crosse, WI
This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination 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 atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better ...
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Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, 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 methotrexate, vinblastine, doxorubicin, 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. Durvalumab in combination with chemotherapy before surgery ...
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A Study to Evaluate RP1 Monotherapy and Combined with Nivolumab
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.
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A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete ...
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Diet in Altering Disease Progression in Patients with Prostate Cancer on Active Surveillance
Rochester, MN
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
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A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return.
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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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Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic 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. 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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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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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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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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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 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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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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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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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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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 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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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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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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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 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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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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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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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
No Locations
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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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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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 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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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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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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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 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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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 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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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 purpose of this study is to document the feasibility of carboplatin mirvetuximab in patients with advanced-stage epithelial ovarian cancer (EOC).
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A Registry for the Collection and Maintenance of Biological Specimens for Breast Cancer Research
Rochester, MN
The purpose of this registry is to collect and maintain samples of breast tissue from women and men undergoing surgery for a breast related concern at Mayo Clinic Rochester, to create a biospecimen resource for the study of benign and cancerous breast conditions.
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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 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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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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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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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 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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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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Comparison of Hepatic Intraarterial vs. Systemic Intravenous 68Ga-PSMA PET/CT to Treat Hepatocellular Carcinoma
Rochester, MN
To determine the tumor radiotracer uptake of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ HCC by PET/CT.
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Defining Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Rochester, MN
The purpose of this study is to define meaningful change in symptoms and physical function for advanced cancer patients receiving treatment.
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A Study of TAK-981 in Combination with Rituximab in Participants with Relapsed/Refractory (r/r) CD20-positive (CD20+) Non-Hodgkin Lymphoma (NHL)
Rochester, MN
The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with rituximab in participants with r/r CD20+ NHL in Phase 1b, and to evaluate the effectiveness of TAK-981 in combination with rituximab in r/r CD20+ NHL in Phase 2.
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Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma
Rochester, MN
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL)
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Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). 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 retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class ...
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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Ependymoma
Rochester, MN
This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to ...
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A Study Using Chemotherapy Followed by Radiation Therapy in Treating Younger Patients with Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Rochester, MN
Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide 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. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
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A Study of Using Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Rochester, MN
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
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LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
No Locations
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations.
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A Study of Shared Decision Making in the Cardiovascular Care of Cancer Patients Seen in the Cardio-oncology Clinic
Rochester, MN
The purpose of this study is to explore, through surveys of providers and patients, the frequency and nature of shared decision making aspects in the cardiovascular care of cancer patients seen in the cardio-oncology clinic referred by an oncology provider.
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An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)
Rochester, MN
The purpose of this study is to evaluate the effectiveness of AAA617 versus observation after Stereotactic Body Radiation Therapy (SBRT), in delaying castration or disease recurrence in adult patients with PSMA
positive OMPC with 1 to 5 metastatic lesions detected by PSMA PET using gallium (68Ga) gozetotide or piflufolastat (18F), negative for M1 disease by conventional imaging (CI).
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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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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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A Study to Evaluate the Epidemiology of Estrogen Genotoxicity in Breast Cancer
Rochester, MN
The purpose of this study is to recruit 2000 incident cases of primary breast cancer in order to perform laboratory assays to measure frequencies of genetic polymorphisms for genes that encode enzymes involved in candidate gene pathways, including: estrogen and catecholestrogen formation, bioactivation and inactivation, cellular proliferation and apoptosis, nuclear factor kappa-beta; to compare genotype frequencies for polymorphisms of genes in breast cancer cases and controls, and to evaluate possible interactions among common polymorphisms in candidate genes.
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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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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 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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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 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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MC200404, Safety and Immunogenicity of PolyPEPI1018 Vaccine in the Treatment of Late-stage Metastatic Colorectal Cancer
Rochester, MN
The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.
PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.
Participants will receive TAS-102 and PolyPEPI1018 which ...
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Saliva and remote monitoring of active Cytomegalovirus infection and symptoms during ovarian cancer treatment
Rochester, MN
The purpose of this project is to determine the feasibility and accuracy of using saliva to remotely monitor CMV infection in individuals receiving treatment for ovarian cancer.
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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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A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Scottsdale/Phoenix, AZ
The purpose of this study is to compare ipilimumab with and without IMO-2125 in advanced melanoma patients.
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A Study to Evaluate the Safety and Effectiveness of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma Patients
Rochester, MN; Jacksonville, FL
The purpose of this 2-part study is to evaluate the safety and effectiveness of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of ...
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Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia or Lobular Carcinoma In Situ
Rochester, MN
The purpose of this study is to analyze breast tissue changes after a short course of Tamoxifen (Tam).
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Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to is to evaluate patients with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.
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A Study of MicroRNAs in Patients with Multiple Myeloma Treaded with Immunomodulatory Drugs
Scottsdale/Phoenix, AZ
The purpose of this study is to explore how IMiD treatments affect certain genetic material called (microRNAs) in the body of patients with multiple myeloma.
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A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be randomized 1:1 to receive one of the following treatment regimens during induction phase:- -Arm A: Tiragolumab plus atezolizumab and CE -Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
No Locations
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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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
Rochester, MN
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 the Effectiveness and Safety of Pembrolizumab Combined with Bacillus Calmette-Guerin in High-Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.
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A Study to Measure the Proteins Expressed in tissue Samples from Women who have been Treated with New Endocrine Therapy for Invasive Lobular Breast Cancer
Rochester, MN
The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.
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A Study of the Safety and Effectiveness of Atezolizumab Combined with Etoposide, and Carboplatin for Patients with Untreated Extensive-Stage Small Cell Lung Cancer
Rochester, MN
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death ligand 1 [anti-PD-L1]) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in treatment-naive participants with extensive-stage small cell lung cancer (ES-SCLC). Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21 day-cycles for 4 cycles in the induction phase followed by maintenance with atezolizumab or placebo until disease progression (PD) as assessed by the investigator using Response Evaluation ...
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A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Rochester, MN
This is a study of pembrolizumab for advanced gastric or gastroesophageal junction adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as combination therapy with cisplatin and 5-Fluorouracil (5-FU) in treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful overall response rate.
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A Study to Determine the Outcomes of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy
Rochester, MN
AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).
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Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Albert Lea, MN; Eau Claire, WI; Mankato, MN; Jacksonville, FL; Rochester, MN; La Crosse, WI
This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination 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 atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better ...
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A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Rochester, MN
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma
No Locations
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
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Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
Rochester, MN
This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an intra-patient dose escalation paradigm based on ...
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Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
No Locations
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...
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Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
Rochester, MN
The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.
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Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma subjects.
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Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, 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 and avelumab together may further shrink the cancer or prevent it from returning/progressing.
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Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (PROTA)
Rochester, MN
The purpose of this study is to evaluate the safety [including dose-limiting toxicities (DLTs)] of the combination therapy of TILT-123 and pembrolizumab in patients with platinum resistant or refractory ovarian cancer.
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Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well nivolumab, with or without ipilimumab, works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic).
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Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, 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 methotrexate, vinblastine, doxorubicin, 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. Durvalumab in combination with chemotherapy before surgery ...
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A Study to Evaluate RP1 Monotherapy and Combined with Nivolumab
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.
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A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete ...
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Diet in Altering Disease Progression in Patients with Prostate Cancer on Active Surveillance
Rochester, MN
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
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A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return.
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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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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 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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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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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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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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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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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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In-home Versus In-Clinic Subcutaneous Nivolumab Administration through Connected and Remote Cancer CARE Beyond Walls
Jacksonville, FL
The purpose of this study is to evaluate the impact of the location of SQ Nivo administration, at the infusion center or in the home, on patient preference and acceptability, safety, patient reported outcomes (PROs), and clinical outcomes.
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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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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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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 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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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 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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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 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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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 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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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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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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A Study to Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as brostallicin 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 brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
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Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
Rochester, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.
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A Study to Evaluate T-DM1 With or Without Abemaciclib in Women and Men with HER2-positive Advanced or Metastatic Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare progression-free survival (PFS) in patients with advanced HER2-positive breast cancer treated with T-DM1 and abemaciclib vs. T-DM1 monotherapy.
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Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Jacksonville, FL
This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled 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 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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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 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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A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
No Locations
The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.
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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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Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
No Locations
The purpose of this study is to determine how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body and cannot be removed by surgery or gallbladder cancer. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer.
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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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Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Rochester, MN
The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
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Efineptakin alfa (NT-I7) Plus Pembrolizumab for the Treatment of Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.
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A Study to Evaluate CB-839 With Radiation Therapy and Temozolomide in Treating Participants With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the side effects and best dose of CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 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 stopping them from spreading. Giving CB-839 with ...
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Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Rochester, MN
RATIONALE: 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. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
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A Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B.
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Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Jacksonville, FL
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food ...
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A Study to Evaluate MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.
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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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Saliva and remote monitoring of active Cytomegalovirus infection and symptoms during ovarian cancer treatment
Rochester, MN
The purpose of this project is to determine the feasibility and accuracy of using saliva to remotely monitor CMV infection in individuals receiving treatment for ovarian cancer.
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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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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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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
No Locations
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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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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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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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 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 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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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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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 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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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 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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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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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 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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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 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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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 purpose of this study is to document the feasibility of carboplatin mirvetuximab in patients with advanced-stage epithelial ovarian cancer (EOC).
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A Registry for the Collection and Maintenance of Biological Specimens for Breast Cancer Research
Rochester, MN
The purpose of this registry is to collect and maintain samples of breast tissue from women and men undergoing surgery for a breast related concern at Mayo Clinic Rochester, to create a biospecimen resource for the study of benign and cancerous breast conditions.
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A Study to Evaluate Intravenous TAEK-VAC-HerBy Vaccine Alone and in Combination Treatment in patients with advanced cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.
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A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.
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A Study to Evaluate Ipilimumab Administered Intra-lymphatically Using the Sofusa® DoseConnect™ DEVICE with IV-administered Nivolumab in Patients with Metastatic Melanoma
Rochester, MN
The primary objective of the overall study is to determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device, followed 30 minutes later by nivolumab IV on Day 1 of a 21-day cycle in patients with metastatic melanoma.
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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 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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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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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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A Study to Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as brostallicin 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 brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
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Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
Rochester, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.
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A Study to Evaluate T-DM1 With or Without Abemaciclib in Women and Men with HER2-positive Advanced or Metastatic Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare progression-free survival (PFS) in patients with advanced HER2-positive breast cancer treated with T-DM1 and abemaciclib vs. T-DM1 monotherapy.
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Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Jacksonville, FL
This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled 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 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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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 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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A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
No Locations
The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.
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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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Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
No Locations
The purpose of this study is to determine how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body and cannot be removed by surgery or gallbladder cancer. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer.
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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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Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Rochester, MN
The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
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Efineptakin alfa (NT-I7) Plus Pembrolizumab for the Treatment of Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.
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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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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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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 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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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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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 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 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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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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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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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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In-home Versus In-Clinic Subcutaneous Nivolumab Administration through Connected and Remote Cancer CARE Beyond Walls
Jacksonville, FL
The purpose of this study is to evaluate the impact of the location of SQ Nivo administration, at the infusion center or in the home, on patient preference and acceptability, safety, patient reported outcomes (PROs), and clinical outcomes.
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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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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 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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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 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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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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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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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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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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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 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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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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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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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 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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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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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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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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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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A Global Study to Assess the Effects of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are ...
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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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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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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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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 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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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 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 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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
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A Study to Evaluate the Safety and Effectiveness of JBH492 in Patients with Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this First-In-Human study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary effectiveness of JBH492 as single agent.
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Comparing the Investigational Imaging System with Sonography
Rochester, MN
The short-term goal of the proposed research is to develop a new method for viscoelasticity imaging of breast that can work with any type of wave, and not restricted to plane shear waves.
The long-term goal of this project is to develop an ultrasound-based breast imaging technique to improve the diagnostic specificity in breast cancer.
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Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease (BMT CTN 1301)
Rochester, MN
The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.
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A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
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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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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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Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions
Scottsdale/Phoenix, AZ; Rochester, MN
This pilot phase II trial studies how well ponatinib hydrochloride works in treating patients with biliary cancer that has spread to other places in the body and that have alterations (fusions) in a gene known as fibroblast growth factor receptor 2 (FGFR2). Ponatinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
Rochester, MN
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
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Pembrolizumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Merkel Cell Cancer
Rochester, MN
This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with merkel cell 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. 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 pembrolizumab with stereotactic body radiation therapy may work better in treating patients with merkel cell cancer.
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
No Locations
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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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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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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A Study of Three-dimensional (3-D) Tissue Models in Patients with Serous Endometrial Cancer Planning to Undergo Surgery
Rochester, MN
The purpose of this research study is to learn more about serous endometrial cancer by creating three-dimensional (3-D) tissue models in the laboratory setting. The tissue models will provide scientists with a reliable, sensitive method to test biomarkers and cellular responses to treatment for endometrial cancer.
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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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First in Human Study of TORL-1-23 in Participants With Advanced Cancer
Rochester, MN
The purpose of tis first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
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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 ...
-
A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
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A Study to Evaluate the Safety and Effectiveness of JBH492 in Patients with Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this First-In-Human study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary effectiveness of JBH492 as single agent.
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Comparing the Investigational Imaging System with Sonography
Rochester, MN
The short-term goal of the proposed research is to develop a new method for viscoelasticity imaging of breast that can work with any type of wave, and not restricted to plane shear waves.
The long-term goal of this project is to develop an ultrasound-based breast imaging technique to improve the diagnostic specificity in breast cancer.
-
Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease (BMT CTN 1301)
Rochester, MN
The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.
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A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
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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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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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Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
No Locations
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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 them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill ...
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Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
Rochester, MN
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to ...
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Assessing Breast Cancer Risk Perception in Hispanic, Black, and Black Hispanic Women
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to understand how women of color from diverse racial and ethnic backgrounds conceptualize their current and lifetime risk for breast cancer (BC) and to identify which risk factors most resonate with perceptions of BC risk.
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Comparison of Hepatic Intraarterial vs. Systemic Intravenous 68Ga-PSMA PET/CT to Treat Hepatocellular Carcinoma
Rochester, MN
To determine the tumor radiotracer uptake of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ HCC by PET/CT.
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Defining Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Rochester, MN
The purpose of this study is to define meaningful change in symptoms and physical function for advanced cancer patients receiving treatment.
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A Study of TAK-981 in Combination with Rituximab in Participants with Relapsed/Refractory (r/r) CD20-positive (CD20+) Non-Hodgkin Lymphoma (NHL)
Rochester, MN
The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with rituximab in participants with r/r CD20+ NHL in Phase 1b, and to evaluate the effectiveness of TAK-981 in combination with rituximab in r/r CD20+ NHL in Phase 2.
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Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma
Rochester, MN
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL)
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Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). 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 retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class ...
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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Ependymoma
Rochester, MN
This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to ...
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A Study Using Chemotherapy Followed by Radiation Therapy in Treating Younger Patients with Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Rochester, MN
Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide 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. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
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A Study of Using Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Rochester, MN
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
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LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
No Locations
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations.
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A Study of Shared Decision Making in the Cardiovascular Care of Cancer Patients Seen in the Cardio-oncology Clinic
Rochester, MN
The purpose of this study is to explore, through surveys of providers and patients, the frequency and nature of shared decision making aspects in the cardiovascular care of cancer patients seen in the cardio-oncology clinic referred by an oncology provider.
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An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)
Rochester, MN
The purpose of this study is to evaluate the effectiveness of AAA617 versus observation after Stereotactic Body Radiation Therapy (SBRT), in delaying castration or disease recurrence in adult patients with PSMA
positive OMPC with 1 to 5 metastatic lesions detected by PSMA PET using gallium (68Ga) gozetotide or piflufolastat (18F), negative for M1 disease by conventional imaging (CI).
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Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
This phase I trial studies the side effects and best dose of selinexor and carfilzomib when given together with dexamethasone in treating patients with multiple myeloma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as selinexor 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. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving selinexor, carfilzomib, and dexamethasone may be a better treatment for ...
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Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
Rochester, MN
The objectives of this study are to reduce the rate of bacterobilia driven surgical site infection (SSI) in patients undergoing pancreatic head resection by providing surgical team with NS data in the post-operative setting, and to reduce cost of care through reduction in SSI and improved antibiotic stewardship.
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A Study to Determine the Best Individualized Cancer Therapy Using Circulating Tumor DNA (ctDNA) in Patients with GI, CNS, and Thoracic Cancers.
Jacksonville, FL
This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.
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Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
Rochester, MN
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as ...
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Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma
Jacksonville, FL
The purpose of this study is to evaluate abemaciclib versus placebo to treat Advanced Dedifferentiated Liposarcoma. Patients with progression of disease will cross over to open label abemaciclib.
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Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Rochester, MN
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
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A Comparison Study to Cross-validate the Linear Analogue Self-Assessment (LASA), Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Assessing Cancer Patient Well-being
Rochester, MN
This study is being done to compare questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the Patient-reported Outcomes Measurement Information System (PROMIS) and the Linear Analogue Self-Assessment (LASA). These are questions which ask patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for future clinical trials. The study items have been developed under a contract from the National Cancer Institute (NCI).
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A Study of HFB200301 in Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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A Study to Evaluate the Surgical Removal of Residual Brain Tumors Prior to Recurrence
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors. Eligible patients with surgically accessible latent tumors desiring surgical resection will be enrolled to prospectively track short- and long-term outcomes. Safety will be evaluated by quantifying rates of surgical morbidity as compared to patients undergoing RT after surgery, or no surgery for similar latent disease. Variables evaluated will include postoperative complications including death within 30 days, wound infection, length of hospital stay, and readmission rates.
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Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to compare the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic).
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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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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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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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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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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 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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A Study of Gene Expression Biomarkers and Bioassay for Radiation Biodosimetry using Human Blood Irradiation Experiments to Study Gene Expression Changes following Radiation Exposure
No Locations
The goal of this study is to investigate gene expression changes in blood (biomarkers) after a person is exposed to radiation. The gene biomarkers identified and selected from data collected in this study will allow healthcare personnel to estimate the level of radiation exposure in an individual as demonstrated by the changes in the levels of these biomarkers. In case of a radiological event, it is beneficial to determine the amount of radiation absorbed, together with other diagnostic tools, to provide important information for medical treatment of the victim. This would be extremely helpful for emergency planning and response. Data ...
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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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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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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 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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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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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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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 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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First in Human Study of TORL-1-23 in Participants With Advanced Cancer
Rochester, MN
The purpose of tis first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
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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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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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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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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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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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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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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 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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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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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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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Albert Lea, MN; La Crosse, WI; Mankato, 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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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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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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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 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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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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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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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 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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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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Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer
Rochester, MN
The purpose of this research study is to see if cancer will respond better to a combination of irinotecan and cetuximab with or without bevacizumab
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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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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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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
No Locations
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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Study Comparing CB-839 with Cabozantinib vs. Cabozantinib with Placebo in Patients with Metastatic Renal Cell Carcinoma
No Locations
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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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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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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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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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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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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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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Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
No Locations
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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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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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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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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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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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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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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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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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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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 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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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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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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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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A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared with Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Jacksonville, FL
This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).
Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day ...
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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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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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(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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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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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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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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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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The Captivator EMR Registry
Rochester, MN; Jacksonville, FL
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Study of Adjuvant Regorafenib vs Placebo in Patients with Node Positive Esophageal Cancer who Completed Pre-operative Therapy
Rochester, MN
The purpose of this research study is to find out what effects, good and/or bad, the drug regorafenib has on stomach or esophagus cancer after completion standard chemotherapy, radiation therapy and surgery prescribed by your doctor. In this study the participant will either get regorafenib or a "placebo".
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A Study of ASTX660 Alone or Combined with ASTX727 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
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Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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ROF2181
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.
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Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate LET-based modeling as an early and accurate predictor for white-matter changes as identified on MRI and DTI in pediatric patients with primary central nervous system and skull base malignancies following proton beam therapy
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VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
Rochester, MN
This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab. A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be randomized to receive either the investigational drug (VAL-083) or "Investigator's choice of salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive VAL-083 at 40 mg/m2 IV on days ...
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Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.
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A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
Rochester, MN
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling).
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Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.
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A Study to Evaluate the Use of a Novel Wearable Device for Temperature Monitoring in Cancer Patients Who Underwent Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.
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Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery ...
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Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
Rochester, MN
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
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma 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 and ipilimumab, 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 ...
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Kinetics of Troponin and BNP in Breast Cancer Chemotherapy with Adriamycin and Trastuzumab
No Locations
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have ...
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Molecular Breast Imaging in Women with Atypia and LCIS
Rochester, MN
We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.
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A Study to Compare Venetoclax with Fulvestrant vs. Fulvestrant Alone in Women with Locally Advanced or Metastatic HER2-negative Cancer who Have Progressed or Recurred on a CDK4/6 Inhibitor
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone for HER2-negative breast cancer.
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A Study to Establish a Living Breast Organoid Biobank for Translational Research
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.
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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
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A Study of T-VEC and Radiation to Treat Localized Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.
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Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial
Jacksonville, FL
The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of all advanced cancer treatments which require immunotherapy. By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 ...
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CTX131 in Relapsed/Refractory Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamic effects of CTX131 in adult study subjects with relapsed or refractory (r/r) hematologic malignancies.
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A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia
La Crosse, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this study is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax works in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of cancer 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 by stopping them from ...
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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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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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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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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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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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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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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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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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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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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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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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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) in Patients with Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL
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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Belantamab, Lenalidomide, and Daratumumab for Newly-diagnosed Multiple Myeloma
Rochester, MN
The purpose of the phase 1 portion of this research study is to find out more about the side effects of belantamab and what doses of belantamab are safe for people when combined with lenalidomide and daratumumab, and to find the right dose for the phase 2 portion of the trial.
This trial is exploring the use of a new drug called belantamab to be used in combination with daratumumab and lenalidomide and not using the same doses of dexamethasone as has been done with previous combinations. Belantamab is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate. This ...
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Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. 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. 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 dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better ...
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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 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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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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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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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 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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A Study to Evaluate Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
No Locations
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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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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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Rochester, MN
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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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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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 of Bladder Filling Variations During Radiation Therapy in Patients Undergoing Radiation Treatment for Prostate Cancer
No Locations
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 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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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 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 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 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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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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Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer
Rochester, MN
The purpose of this research study is to see if cancer will respond better to a combination of irinotecan and cetuximab with or without bevacizumab
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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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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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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
No Locations
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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Study Comparing CB-839 with Cabozantinib vs. Cabozantinib with Placebo in Patients with Metastatic Renal Cell Carcinoma
No Locations
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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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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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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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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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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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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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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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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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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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
No Locations
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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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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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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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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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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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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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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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 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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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 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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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 A2B694, a Logic-gated CAR T, in Subjects 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 A2B694, 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), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression.
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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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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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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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Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
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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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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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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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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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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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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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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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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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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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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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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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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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 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 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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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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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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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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Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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ROF2181
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.
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Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate LET-based modeling as an early and accurate predictor for white-matter changes as identified on MRI and DTI in pediatric patients with primary central nervous system and skull base malignancies following proton beam therapy
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The Captivator EMR Registry
Rochester, MN; Jacksonville, FL
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Study of Adjuvant Regorafenib vs Placebo in Patients with Node Positive Esophageal Cancer who Completed Pre-operative Therapy
Rochester, MN
The purpose of this research study is to find out what effects, good and/or bad, the drug regorafenib has on stomach or esophagus cancer after completion standard chemotherapy, radiation therapy and surgery prescribed by your doctor. In this study the participant will either get regorafenib or a "placebo".
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A Study of ASTX660 Alone or Combined with ASTX727 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
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Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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A Study to Evaluate the Use of a Novel Wearable Device for Temperature Monitoring in Cancer Patients Who Underwent Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.
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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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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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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 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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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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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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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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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 A2B694, a Logic-gated CAR T, in Subjects 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 A2B694, 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), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression.
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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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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
No Locations
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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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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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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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, 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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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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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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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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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 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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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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ROF2181
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.
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Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate LET-based modeling as an early and accurate predictor for white-matter changes as identified on MRI and DTI in pediatric patients with primary central nervous system and skull base malignancies following proton beam therapy
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The Captivator EMR Registry
Rochester, MN; Jacksonville, FL
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Study of Adjuvant Regorafenib vs Placebo in Patients with Node Positive Esophageal Cancer who Completed Pre-operative Therapy
Rochester, MN
The purpose of this research study is to find out what effects, good and/or bad, the drug regorafenib has on stomach or esophagus cancer after completion standard chemotherapy, radiation therapy and surgery prescribed by your doctor. In this study the participant will either get regorafenib or a "placebo".
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A Study of ASTX660 Alone or Combined with ASTX727 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
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Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
Rochester, MN
This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab. A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be randomized to receive either the investigational drug (VAL-083) or "Investigator's choice of salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive VAL-083 at 40 mg/m2 IV on days ...
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Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.
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A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
Rochester, MN
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling).
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Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.
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A Study to Evaluate the Use of a Novel Wearable Device for Temperature Monitoring in Cancer Patients Who Underwent Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.
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Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery ...
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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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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 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 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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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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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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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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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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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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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 of Bladder Filling Variations During Radiation Therapy in Patients Undergoing Radiation Treatment for Prostate Cancer
No Locations
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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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Rochester, MN
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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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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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 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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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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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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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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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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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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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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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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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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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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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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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 of Nab-Paclitaxel as Maintenance Treatment After Cisplatin-Based Chemotherapy and Surgery for Patients with High-Risk Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate nab-paclitaxel as maintenance therapy after cisplatin-based chemotherapy and surgery in treating patients with high-risk bladder cancer. Maintenance therapy, such as paclitaxel albumin-stabilized nanoparticle formulation, can help keep cancer from coming back after it has disappeared following initial chemotherapy.
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Combination Chemotherapy or 90-Yttrium Ibritumomab Tiuxetan and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Relapsed Diffuse Large B-cell Non-Hodgkin Lymphoma
No Locations
This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination chemotherapy compared with combination chemotherapy alone before stem cell transplant in treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a period of improvement. Radioactive substances linked to monoclonal antibodies, such as 90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by ...
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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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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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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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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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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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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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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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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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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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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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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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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 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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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
Jacksonville, FL; Scottsdale/Phoenix, AZ
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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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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A Study to Evaluate Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
No Locations
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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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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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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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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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 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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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 of Bladder Filling Variations During Radiation Therapy in Patients Undergoing Radiation Treatment for Prostate Cancer
No Locations
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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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Rochester, MN
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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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 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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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 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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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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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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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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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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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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Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
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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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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CT of the Breast: Feasibility and Comparison with MRI in Women with Breast Cancer
No Locations
The purpose of this study is to estimate the performance (sensitivity, specificity, accuracy) of dual-energy CT of the breast for detection of breast cancer in the ipsilateral and contralateral breast compared to standard multihance breast MR imaging. To determine the optimal workflow and images needed (multiplanar reconstructions, color maps, etc.) needed for routine interpretation of DE or quantitative CT imaging of contrast enhanced breast DECT.
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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 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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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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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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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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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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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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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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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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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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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 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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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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A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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 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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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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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 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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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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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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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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Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
Rochester, MN
This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.
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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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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Rochester, MN
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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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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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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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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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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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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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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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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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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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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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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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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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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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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A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
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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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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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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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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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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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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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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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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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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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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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
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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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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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 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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A Study of Alisertib in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1)
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
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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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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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 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 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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A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Scottsdale/Phoenix, AZ; Jacksonville, FL; 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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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
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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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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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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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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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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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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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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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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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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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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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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Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).
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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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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
Jacksonville, FL; Rochester, MN; Albert Lea, MN; 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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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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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Rochester, MN
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Breast Cancer, Reasoning, And Activity Intervention
Scottsdale/Phoenix, AZ
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health ...
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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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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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A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
Jacksonville, FL
The purpose of this study is to confirm a safe dose and schedule as well as the preliminary effectiveness of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with acute myeloid leukemia (AML) who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.
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Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.
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Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection
Rochester, MN
The objectives of this study are to determine the impact of omega-3 supplementation on promoting facial nerve function recovery, and to determine the impact of omega-3 supplementation on Vestibular schwannoma (VS) tumor control.
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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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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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A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of 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 determine the safety and tolerability of BMS-986393 in combination with alnuctamab, mezigdomide, or iberdomide in participants with relapsed or refractory multiple myeloma (RRMM), and to define the RP2D of alnuctamab, mezigdomide, or iberdomide in combination with BMS-986393 in participants with (RRMM).
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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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18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
Jacksonville, FL
The goal of this study is to further evaluate the ability of fluciclovine PET to discriminate between radiation necrosis and tumor progression in patients with previously irradiated intracranial metastatic disease.
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A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
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Intervention for Children Undergoing Proton Radiation for Brain Cancer
Rochester, MN
The purpose of this study is to develop and pilot a novel early intervention program for children undergoing proton radiation thereapy (PRT) for brain tumors.
Survivors of childhood brain cancers who undergo radiation therapy can have damage to normal brain tissue. Activities such as attention training and physical exercise can improve mental function in children with brain injury that is caused by the radiation therapy. Improvements in children’s ability to learn, behavior and fitness will lead to a better developmental outcome and quality of life in the longer term.
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A Study of Intratumoral Injection of Dendritic Cells after High-Dose Conformal External Beam Radiotherapy in Patients with Unresectable Liver Cancer
Rochester, MN
Group 1: The primary purpose of this study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).
Group 2: The primary purpose of this study is to estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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A Study to Compare Dual-Energy CT and Whole Body MRI for Monitoring of Bone Involvement in Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to determine the performance of Dual-Energy CT (DECT) with Virtual Non-calcium (VNCa) and fat measurement in assessing multiple myeloma disease activity following treatment, with MRI and clinical/ laboratory parameters as reference standards.
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A Study to Evaluate Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to 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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A Study to Evaluate Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/ Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Rochester, MN; Jacksonville, FL
The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.
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A Study to Evaluate Mindfulness Intervention During Radiotherapy
Rochester, MN
The purpose of this study is to evaluate the effectiveness of a mindfulness-based intervention (MBI) on subjective reports of wellness including emotional, physical, functional, and social domains during radiotherapy for the treatment of cancer.
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A Study to Compare Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 or more brain metastases.
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FRACTIONATE
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from ...
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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
Rochester, MN
For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The ...
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A Study to Evaluate Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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A Study to Assess Cisplatin and Combination Chemotherapy in Treating Children and Young Adults with Hepatoblastoma or Liver Cancer After Surgery
Rochester, MN
The purpose of this study is to determine how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine 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. Giving combination chemotherapy after surgery may kill more tumor cells.
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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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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 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 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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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 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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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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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 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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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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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 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 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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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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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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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 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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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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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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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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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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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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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 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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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 of the Effectiveness and Safety of CTL019 in Adult Patients with Diffuse Large B-Cell Lymphoma
No Locations
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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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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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 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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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 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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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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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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A Study to Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.
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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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Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
Rochester, MN
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
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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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Primary Breast Oligoprogressive Metastatic Disease Treated with Stereotactic Body Radiation Therapy to Obviate the Need to Change Systemic Therapy (BOSS)
Rochester, MN; Scottsdale/Phoenix, AZ
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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LS138D, Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma
Rochester, MN
This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab is more effective with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.
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A Study in Treating Patients With Kidney Cancer Undergoing Nephrectomy Comparing PERioperative Nivolumab vs. Observation
Rochester, MN
The purpose of this randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone ...
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Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa)
Rochester, MN
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
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Trial of Sequential Treatment of Multiple Myeloma with Antibody Therapy
Jacksonville, FL
The purpose of this study is to determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with multiple myeloma resistant to daratumumab.
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Longterm Follow-up of Subjects Treated With bb2121
Rochester, MN
This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.
bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No ...
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A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.
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A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.
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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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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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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 of the Effectiveness and Safety of CTL019 in Adult Patients with Diffuse Large B-Cell Lymphoma
No Locations
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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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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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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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 to Compare Dual-Energy CT and Whole Body MRI for Monitoring of Bone Involvement in Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to determine the performance of Dual-Energy CT (DECT) with Virtual Non-calcium (VNCa) and fat measurement in assessing multiple myeloma disease activity following treatment, with MRI and clinical/ laboratory parameters as reference standards.
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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A Study to Evaluate Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to 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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A Study to Evaluate Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/ Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Rochester, MN; Jacksonville, FL
The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.
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A Study to Evaluate Mindfulness Intervention During Radiotherapy
Rochester, MN
The purpose of this study is to evaluate the effectiveness of a mindfulness-based intervention (MBI) on subjective reports of wellness including emotional, physical, functional, and social domains during radiotherapy for the treatment of cancer.
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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
Rochester, MN
For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The ...
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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A Study to Compare Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 or more brain metastases.
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FRACTIONATE
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from ...
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A Study to Evaluate Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
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A Study to Assess Cisplatin and Combination Chemotherapy in Treating Children and Young Adults with Hepatoblastoma or Liver Cancer After Surgery
Rochester, MN
The purpose of this study is to determine how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine 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. Giving combination chemotherapy after surgery may kill more tumor cells.
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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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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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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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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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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 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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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 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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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 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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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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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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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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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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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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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 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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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.
-
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.
-
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 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.
-
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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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.
-
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 ...
-
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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A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
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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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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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Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
Eau Claire, WI; Rochester, MN
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
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A Multi-Center Study Evaluating KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
No Locations
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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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Rochester, MN
There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women ...
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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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A Study to Evaluate the Safety and Effectiveness of ALLO-501A CAR T Cell Therapy in Adults with Relapsed/
Refractory Large B Cell Lymphoma
Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).
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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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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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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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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 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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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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Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to see if giving lenzilumab prior to axicabtagene ciloleucel will reduce the neurologic side effects of axicabtagene ciloleucel when used to treat lymphoma.
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A Study Comparing CAR-T Therapy Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants with Relapsed and Lenalidomide-Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
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A Study Evaluating the Effectiveness and Safety of Axicabtagene Ciloleucel in Subjects with High-Risk Large B-Cell Lymphoma
Rochester, MN
The purpose of this study is to to estimate the effectiveness of axicabtagene ciloleucel, as measured by complete response (CR) rate, in subjects with high-risk large B-cell lymphoma.
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A Study Evaluating KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)
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).
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Defining the Immunologic Profile of Sentinel Lymph Nodes and Identifying the Mechanisms Responsible for Immunosuppression
Rochester, MN; Jacksonville, FL
The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.
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A Study Comparing Sublobar Resection versus Stereotactic Ablative Radiotherapy for Lung Cancer
No Locations
The purpose of this study is to determine if Stereotactic Ablative Radiotherapy improves survival over sublobar resaction in high risk operable stage I non-small cell lung cancer.
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A Study to Evaluate the Effectiveness and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects with Clinical High-Risk Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subjects with 1 prior anti-myeloma treatment regimen and HR disease defined as Stage III by the Revised International Staging System (R-ISS) and early relapse. The cohorts will start in ...
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Long-Term Study of Participants Previously with Ciltacabtagene Autoleucel
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to collect data on delayed adverse events after administration of cilta-cel in a previous clinical study, and to characterize and understand the long-term safety profile of cilta-cel.
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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 to Evaluate Left and Right Ventricular Function in Relation to Exercise Capacity in Breast Cancer Survivors
Jacksonville, FL
The purpose of this study is to determine if exercise improves cardiac remodeling as a way to mitigate the negative effects of chemotherapy and radiation therapy which lead to reduced exercise tolerance.
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Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)
Rochester, MN
The purpose of this trilal is to study a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.
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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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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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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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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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MC230813 A Study of Golcadomide with Rituximab prior to CAR-T with Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
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 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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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 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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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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Stereotactic Body Radiation Therapy in Treating Patients with Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Rochester, MN
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
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A Study to Compare Tisagenlecleucel vs. Standard of Care in Adult Patients with Aggressive B-cell Non-Hodgkin Lymphoma
Jacksonville, FL
This is a randomized, open label, multicenter phase III trial to determine the efficacy and safety of tisagenlecleucel treatment strategy in adult patients with relapsed or refractory aggressive B-cell NHL after failure of rituximab and anthracycline containing frontline immunochemotherapy.
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Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
Rochester, MN; Jacksonville, FL
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
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A Study to Evaluate Daratumumab in Treating Transplant-Eligible Participants with Multiple Myeloma
Jacksonville, FL
To determine the percentage of patients achieving MRD negativity by MPF after autologous stem cell transplant (SCT) (at Day 100) using pre-SCT daratumumab consolidation.
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A Phase 1-2 Multi-Center Study Evaluating Axicabtagene Ciloleucel in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).
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Study of bb21217 in Multiple Myeloma
Rochester, MN
Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).
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A Study to Evaluate Daratumumab in Treating Transplant-Eligible Participants with Multiple Myeloma
Jacksonville, FL
To determine the percentage of patients achieving MRD negativity by MPF after autologous stem cell transplant (SCT) (at Day 100) using pre-SCT daratumumab consolidation.
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Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers
Rochester, MN
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.
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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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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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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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A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
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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
No Locations
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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Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
Eau Claire, WI; Rochester, MN
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Rochester, MN
There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women ...
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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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A Study to Evaluate the Safety and Effectiveness of ALLO-501A CAR T Cell Therapy in Adults with Relapsed/
Refractory Large B Cell Lymphoma
Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).
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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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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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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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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 Evaluate the Safety and Effectiveness of Axicabtagene Ciloleucel in Combination with Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)
Jacksonville, FL; Rochester, MN
The primary objective of this study is to estimate the safety and effectiveness of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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 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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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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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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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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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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Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity Modulated Radiation Therapy After Surgery for the Treatment of Endometrial or Cervical Cancer
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
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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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 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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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 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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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 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 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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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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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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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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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 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 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 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 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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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.