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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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Dynamics Of Clinical Trial Discussions In Oncology To Identify Patient Barriers And Help Develop A Patient-centered Intervention To Increase Participation In Clinical Trials
Rochester, MN
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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Iobenguane I-131 Or Crizotinib And Standard Therapy In Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma Or Ganglioneuroblastoma
Rochester, MN
Despite recent improvements in outcome for children with newly diagnosed high-risk neuroblastoma, cure rates remain unsatisfactory.Further, these gains have been the result of interventions during the Consolidation (tandem autologous stem cell transplant) and Post-Consolidation (dinutuximab immunotherapy) phases of treatment, while rates of disease control during Induction have not improved in recent COG trials. The current phase 3 trial seeks to improve the event-free survival (EFS) for children with high-risk neuroblastoma through early integration of promising novel targeted therapies: targeted radiopharmaceutical therapy with 131I-MIBG or the ALK inhibitor, crizotinib. After enrollment, patients will receive one cycle of Induction chemotherapy. Subsequent therapy ...
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Hereditary Cancer Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a clinical registry database of all patients seen at Mayo Clinic Florida who have completed genetic testing through Mayo Clinic Florida or are seen due to a previously identified hereditary cancer risk.
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A Study To Assess Disease Activity And Adverse Events Of Intravenous (IV) Telisotuzumab Vedotin Compared To IV Docetaxel In Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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Specimen Collection From Participants Due For Colorectal Cancer Screening, Surveillance, Or Treatment
Rochester, MN
The purpose of this study is to collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.
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Study Of VS-6766 + Adagrasib In KRAS G12C NSCLC Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
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A Study Of RLY-4008 In Patients With Intrahepatic Cholangiocarcinoma And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study To Evaluate Belinostat And Guadecitabine Or ASTX727 To Treat Unresectable And Metastatic Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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An Investigational Scan (Ga-68 PSMA-11 PET/CT) For Detection Of Disease Recurrence Or Progression In Patients With Glioma
Rochester, MN
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a ...
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A Study Of Selpercatinib Following Definitive Locoregional Treatment In Participants With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to compare Event-Free Survival (EFS) of participants in the primary analysis population with Stage II-IIIA RET fusion-positive Non-small Cell Lung Cancer (NSCLC) treated with selpercatinib versus placebo.
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Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
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A Study To Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of ...
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Study Of GI-102 And PD-1 In Glioblastoma
Rochester, MN
The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.
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Patient And Caregiver Perspective About Financial Distress Of Cancer Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to understand the need and gap in interventions addressing financial burden from a patient perspective, and develop a psychoeducational intervention directed towards decreasing financial distress in patients undergoing cancer treatment based on the knowledge gained.
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A Study To Assess A New Personalized Tool For Colorectal Cancer Peritoneal Disease Treatment
Rochester, MN
The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.
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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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FOG-001 In Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.
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In-home Intravesical Chemotherapy For The Treatment Of Bladder Cancer, INVITE Trial
Jacksonville, FL
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. ...
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A Study Of Abenacianine (VGT-309) To Identify Cancer When Undergoing Surgery For Cancer In The Lung
Rochester, MN
The purpose of this study is assess the efficacy of abenacianine with near-infrared (NIR) imaging as an adjunct for lesion visualization and surgical guidance when compared to standard surgical techniques in subjects undergoing surgery for suspected or proven cancer in the lung.
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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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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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Calaspargase Pegol On The Coagulation System In Pediatric Acute Lymphoblastic Leukemia (ALL) Patients
Rochester, MN
The purpose of this study is to evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in Pediatric Acute Lymphoblastic Leukemia (ALL) patients.
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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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Using 18F-FAPI PET To Detect Metastatic Disease In Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
Rochester, MN
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. ...
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A Study Of Surgical Drain Fluid For Detection Of Molecular Residual Disease (MRD) In Esophageal Cancer And Thymic Epithelial Tumors
Rochester, MN
To investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic recurrence or progression at 12- and 24- months post-surgery in patients with esophageal cancer and thymic epithelial tumors
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A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
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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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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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Caris Biorepository Research Protocol
Scottsdale/Phoenix, AZ
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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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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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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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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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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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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Study Of Lunresertib Alone Or In Combination With RP-3500 Or Debio 0123 In Patients With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
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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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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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A Study To Investigate The Safety And Efficacy Of KQB365 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365.
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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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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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64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Rochester, MN
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
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Lung-MAP: A Master Screening Protocol For Previously-Treated Non-Small Cell Lung Cancer
Jacksonville, FL; 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 (Lung-MAP). 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 non-match sub-studies which will include all ...
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Testing The Use Of The Combination Of Selumetinib And Olaparib Or Selumetinib Alone Targeted Treatment For RAS Pathway Mutant Recurrent Or Persistent Ovarian And Endometrial Cancers, A ComboMATCH Treatment Trial
Jacksonville, FL; Rochester, MN
The purpose of this phase II ComboMATCH treatment trial is to compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway.
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Low-grade UTUC Treated With Nadofaragene Firadenovec Administered To Renal Pelvis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.
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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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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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Phase II Trial Of Single Agent Belzutifan Or Pembrolizumab Versus Combination As Neoadjuvant Therapy In Clear Cell Renal Cell Carcinoma (BLAZE)
Rochester, MN
To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.
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A Study Of Exploring Health Communication Message Factors That Influence Cancer Research Recruitment
Jacksonville, FL; Rochester, MN
The purpose of this study is to examine how informed consent format influences patient comprehension, uncertainty, self-efficacy, and consent satisfaction.
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Study Of Daraxonrasib (RMC-6236) In Patients With Resected 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 of care (SOC) observation only.
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FORTIFI-HN01: A Study Of Ficerafusp Alfa (BCA101) Or Placebo In Combination With Pembrolizumab In First-Line PD-L1-pos, R Or M HNSCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
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An Expanded Access Program Of Cretostimogene Grenadenorepvec For Treatment Of NMIBC For Patients Unresponsive To BCG
Rochester, MN
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
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A Study To Investigate The Safety And Efficacy Of KQB168 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after ...
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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
Jacksonville, FL; 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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A Study Of Ifinatamab Deruxtecan In Subjects With Pretreated Advanced Or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Scottsdale/Phoenix, AZ; Rochester, MN
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).
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A Study Of Mocertatug Rezetecan In Combination With Anti-cancer Therapies For Advanced Solid Tumors
Rochester, MN
Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available ...
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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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Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of a ddPCR assay for the detection of mutations associated with uveal melanoma. The performance characteristics of the ddPCR assay for the detection of ctDNA mutation in uveal melanoma patients will be assessed by comparing the mutation results obtained for the ddPCR assay on blood to those obtained on paired paraffin embedded tumors.
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A Study To Follow Durability Of Patient Responses From Studies UT001 And TC-BC-12
Jacksonville, FL; Rochester, MN
The purposes of this study are to determine the durability of response in patients with low grade upper tract urothelial carcinoma (LG-UTUC) treated with JELMYTO in Study UT001 who completed the study with a durable response, and the durability of response in patients with low grade non-muscle invasive bladder cancer (LG-NMIBC) treated with UGN-102 in Study TC-BC-12 who completed the study with a durable response.
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VG161 In The Treatment Of Patients With Hepatocellular Carcinoma Or Intrahepatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.
The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).
The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.
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Clinical Features, Prognostic Factors, Local Control Modalities, Survival, and Outcomes of Ewing Sarcoma in Pediatric and Adult Patients
Rochester, MN
The purpose of this study is to compare clinical features and outcomes for children and adults with Ewing Sarcoma at the same institution and add to the limited clinical literature on adults with Ewing Sarcoma.
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Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.
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Study Of REGN4018 Administered Alone Or In Combination With Cemiplimab In Adult Patients With Recurrent Ovarian Cancer Or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Rochester, MN
Primary Objectives In the Dose Escalation Phase:
- To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.
In the Dose Expansion Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Objectives In the Dose Escalation Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR ...
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A Study Of Vesicles, Prostate Cancer
Rochester, MN
The purpose of this study is to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) and circulating tumor DNA (ctDNA) across time and treatments.
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A Study To Investigate ALE.P02 As Monotherapy In Adult Patients With Selected CLDN1+ Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
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A Study to Evaluate the Effectiveness and Safety of P276-00 for Mantle Cell Lymphoma that has Returned and/or is Resistant to Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.
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A Study 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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The Impact Of A Geriatric Assessment In Elderly Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (≥ 65 years) with multiple myeloma (MM).
Multiple myeloma (MM) is a blood cancer that affects a type of white cell called plasma cell. It mainly affects older individuals and has an average age at diagnosis of 69 years.
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A Study To Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs To Treat Patients With Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab Monotherapy In Participants With Select B-Cell Malignancies (MorningSun)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).
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A Study To Evaluate The Development Of Patient Derived Xenografts In Patients With Breast Cancer
Rochester, MN
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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Long-term Follow Up Of Patients Previously Enrolled In MC1137 (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to extend the follow up on the BEAUTY study (MC1137) cohort and collect additional blood samples to evaluate for minimal residual disease and tissue at the time of any breast cancer recurrence.
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Study Of NMS-03597812 In Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
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A Study Of How Current Treatments Impact The Course Of Relapsed Myeloma And The Effect Of The Treatments On The Quality-of-life Measurements.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine the impact of standard of care therapies for TCR MM, in a real-world setting, on patient-reported symptoms, functioning, and QoL, measured prospectively using questionnaires. The secondary goal is to asses clinical endopoints associated with standard of care therapies for TCR MM, in a real-world setting during 12 months of observation.
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BCL2 Inhibitor Venetoclax With Daratumumab-Lenalidomide-Dexamethasone Or Venetoclax-Rd For Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose Dd combination (Arm A), Rd combination (Arm B) or daratumumab, lenalidomide and dexamethasone (Arm C) in patients with newly diagnosed t(11;14) multiple myeloma (MM).
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A Study Of RP2 With Nivolumab Compared To Ipilimumab With Nivolumab With Metastatic Uveal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS) and to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS).
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Prospective Pancreatic Cancer Precision Oncology Treatment Outcomes Registry (PROCTOR)
Rochester, MN
The purpose of this study is to establish a prospective, longitudinal registry of patients with pancreatic cancer receiving clinician-directed therapy in routine practice, including FDA-approved agents used off-label or even investigational agents under a single-patient IND, in order to characterize real-world treatment patterns, effectiveness, and safety and to evaluate how clinical and tumor features, including molecular characteristics, relate to outcomes.
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A Solid Tumor Study For Long Term Treatment Of Cancer Patients Who Participated In Adagrasib Studies
Rochester, MN
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.
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Risk Stratified De-escalated De-intensified Treatment For High Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.
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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.
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Monitoring Symptoms To Help Young Women Take Hormone Therapy For Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; Eau Claire, WI; La Crosse, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study Of LY4584180 In Adult Participants With Previously Treated Blood Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.
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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 To Assess Adverse Events Of Intravenously (IV) Infused ABBV-383 In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383.
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A Study To Evaluate KIN-2787 In Participants With BRAF And/or NRAS Mutation Positive Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
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KO-2806 Monotherapy And Combination Therapies In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
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A Study To Evaluate Lymphoma Epidemiology
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to build a large and diverse observational cohort to support broad and cutting-edge research focused on non-Hodgkin lymphoma (NHL) prognosis and survivorship.
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Phase 3 Study Of Pelabresib (CPI-0610) In Myelofibrosis (MF) (MANIFEST-2)
Jacksonville, FL
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
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Using 18F-FAPI PET To Detect Metastatic Disease In Patients That Have Gastric Or Esophageal Cancer.
Rochester, MN
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to ...
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A Study Of An MMSET Inhibitor In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).
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Preclinical drug testing and assay development for lung adenocarcinoma characterized by the expression of ASCL1
Rochester, MN
The purpose of this study is to perform preclinical testing in patient samples and experimental models.
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Cancer Distress
Rochester, MN
The purpose of this study is to explore patient feedback regarding how physician behaviors influence their distress level.
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A Study Of ABBV-383 With Relapsed Refractory Waldenström Macroglobulinemia
Rochester, MN
The purpose of this study is to determine the safety, maximum tolerated dose (MTD) and RP2D of ABBV-383 monotherapy for patients with RRWM and to determine VGPR or deeper response as the best response achieved with ABBV 383 within 12 cycles of initiation of therapy for patients with RRWM.
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Melanoma Care Barriers In United States Latinx Population
Scottsdale/Phoenix, AZ
The purpose of this study is to provide qualitative analysis of barriers to melanoma care in the United States Latinx Population.
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Do Patients Diagnosed With Cancer Suffer From "scan-itis"?
Rochester, MN
The purpose of this study is to determine what patients experience when they return for scans or other testing during their oncology follow-up visits after their initial cancer diagnosis.
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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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IFX_HU2.0 As An Adjunctive Therapy To Pembrolixumab In Checkpoint Inhibitor Naive Subjects With Advanced Or Metastatic Merkel Cell Carcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) between subjects treated with intralesional administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab, and subjects treated with placebo followed by pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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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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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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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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Social Determinants Of Migrant Health Factors Impacting Prostate Cancer Care And Survivorship Among Sub-Saharan African And Caribbean Immigrant Men
Jacksonville, FL; Rochester, MN
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.
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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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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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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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Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
No Locations
This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
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A Study Of CG-806 In Patients With Relapsed Or Refractory CLL/SLL Or Non-Hodgkin's Lymphomas
Scottsdale/Phoenix, AZ; 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 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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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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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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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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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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Zanzalintinib Versus Everolimus In Participants With Locally Advanced Or Metastatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
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FrαDcs Or Placebo For Patients With Advanced Stage Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study Of Raludotatug Deruxtecan (R-DXd) In Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
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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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A Study To Learn About The Medicine Called PF-08634404 Dosed Alone And In Combination With Other Anticancer Therapies In Adults With Locally Advanced Or Metastatic Renal Cell Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.
To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.
Participants will receive study medicine either ...
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Clinical Study Protocol For Cutaneous SCC For Immunocompromised Patients
Rochester, MN
This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:
1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.
2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
3. Assess Local control up to 12 months after DaRT insertion.
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A Study Of Flyte System Transvaginal Mechanotherapy For Endometrial And Cervical Cancer
Rochester, MN
The purpose of this study is to evaluate the usability and efficacy of Flyte, a home-based transvaginal mechanotherapy device, in the treatment of urinary incontinence in women who have received adjuvant radiation therapy, and to measure the associated improvement in overall quality of life. A secondary objective includes the feasibility of using the Flyte System to improve access to urinary incontinence treatment for patients in rural areas or those who experience difficulties traveling for in-person care.
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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...
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Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of BL-M05D1 In Subjects With Solid Tumors
Scottsdale/Phoenix, AZ
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
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Novel Study Interventions And Combinations In Participants With Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with CRC.
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A Platform Study In Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
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First In Human Study Of TORL-4-500 In Participants With Advanced Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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 LY3484356 Alone Or Combined With Anticancer Therapies To Treat Patients With Breast Or Endometrial Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the recommended Phase 2 dose (RP2D) of LY3484356 administered as monotherapy and in combination with other anticancer therapies in patients with locally advanced or metastatic ER+ breast cancer or ER+ recurrent, persistent, or metastatic endometrial endometrioid cancer (EEC).
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Mapping Patient-Centered Decision-Making In
Metastatic Cancer Care Delivery In Florida
Jacksonville, FL
The purpose of this study is to explore and describe metastatic breast cancer (mBC) and metastatic urothelial cancer (mUC) patient perspectives on and experiences with treatment decision-making, including how patients evaluate various treatment options, associated benefits, risks and drawbacks as well as how perceptions and preferences change over time.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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A Study Of The Safety And Effectiveness Of HBI-8000 With Nivolumab To Treat Melanoma, Renal Cell Carcinoma And Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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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 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 Clinical Study To Test If An Investigational Treatment Called BNT326 Is Safe And Potentially Beneficial When Used Alone Or In Combination With Other Investigational Treatments Such As BNT327, For People With Advanced Malignant Tumors
Scottsdale/Phoenix, AZ
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.
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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 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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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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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 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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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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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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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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Resectable, Borderline Resectable, And Locally Advanced Pancreatic Cancer Biorepository Of Peripheral Blood
Rochester, MN
This biorepository is meant to collect longitudinal peripheral blood research samples for the purposes of biomarker studies. Such studies are meant for the purposes of measuring minimal residual disease in the perioperative setting, assess dynamics of treatment response, and to determine predictive value of risk stratification.
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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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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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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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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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Study Of IBI3020 Treatment In Participants With Late-Stage Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
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A Study Of Tyrosine Kinase Inhibitor ICP-022 In Patients With R/r B-Cell Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The main purpose of this study is to assess the maximal dose of ICP-022 that can be safely administered.
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Leveraging Methylated DNA Markers (MDMs) In The Detection Of Endometrial Cancer And Cervical Cancer: A Phase II Clinical Study
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
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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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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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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Use Of A Digital Application To Implement Healthy Habits And Deal With Symptoms Associated With Breast Cancer Treatment: Fatigue, Sexual Dysfunction, Insomnia And Hot Flushes
Rochester, MN
The population of breast cancer (BC) survivors has reached 3.6 million and continues to grow, concomitant with a projected shortage of oncology providers. BC survivors often feel lost in the year following definitive treatment, and they are not only at risk for recurrence but also risk for persistent treatment-related symptoms. Novel ways to care for a booming population of survivors are needed. This study explores the usability of an interactive care plan (ICP), a digital tool to actively engage and guide breast cancer survivors in their post-treatment, longitudinal care. The ICP provides digital support to assesses common side effects ...
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Pirtobrutinib And Venetoclax With MRD Detection For Previously Untreated Chronic Lymphocytic Leukemia
Rochester, MN
This phase II trial studies how well pirtobrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This study also seeks to adopt a blood test which shows a small number of cancer cells in the body after cancer treatment called minimal residual disease as a guide to determine length of treatment. Drugs used in chemotherapy, such as pirtobrutinib and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Identifying minimal residual disease results after combination chemotherapy may help guide future ...
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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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First In Human Study Of TUB-030 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer ...
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A Study Of The Mechanism Of Origin In Germ Cell Tumor-associated Hematologic Malignancies
Rochester, MN
The purpose of this study is to characterize the mechanism of origin of GCT-associated hematologic malignancies through comprehensive cytogenetic and molecular genetic testing of specimens representing the hematologic malignancy, GCT tissue, and unaffected tissue (for germline component subtraction).
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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)
Jacksonville, FL; Rochester, MN
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 Of Emiltatug Ledadotin (Emi-Le) In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Study of Emi-Le in Participants with Solid Tumors
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A Study Of Zanzalintinib In Participants With Recurrent Or Progressive Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
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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) or small lymphocytic lymphoma (SLL). 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 three 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, ...
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A Study Of 177Lu-FAP-2286 In Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents.
Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for \[177Lu\]Lu FAP ...
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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 XmAb®819 In Subjects With Advanced Clear Cell Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
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Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia
Albert Lea, MN; Mankato, MN; Rochester, 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 Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer
Rochester, MN
The purpose of this study is to determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.
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Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
Rochester, MN
This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
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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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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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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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Testing Teclistamab (TECVAYLI) In Combination With Iberdomide For Hard-to-Treat Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, ...
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Melanoma In-transit Tissue Bank And Molecular Analysis For Personalized Therapies
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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A Qualitative Study of Mayo Clinic Calabresi Scholars and Former Scholars
Rochester, MN
To learn from scholars and former scholars of the Mayo Clinic Cancer Center’s “Paul Calabresi Clinical Oncology (K12) Training Program” in their own words what helped them and what did not help them from a career development standpoint.
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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A Study Of LSTA1 When Added To Standard Of Care Versus Standard Of Care Alone In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma. The main questions it aims to answer are: -is the new drug plus standard treatment safe and tolerable -is the new drug plus standard treatment more effective than standard treatment.
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PRE-I-SPY Phase I/Ib Oncology Platform Program
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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Testing Olaparib For One Or Two Years, With Or Without Bevacizumab, To Treat Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5\'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib ...
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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A Study Of JNJ-90009530 In Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma (R/r B-NHL)
Rochester, MN
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: -can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
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DAREON™-9: A Study To Test How Well Different Doses Of BI 764532 Are Tolerated By People With Small Cell Lung Cancer When Taken Together With A Single Agent Chemotherapy
Jacksonville, FL
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study ...
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DNA And RNA Testing In Patients With Hereditary Cancer Syndromes
Rochester, MN
The purpose of this study is to evaluate the performance characteristics of RNA sequencing. To investigate the utility of RNA analysis in diagnosis of patients with cancer predisposition syndromes and collection of patient samples with pathogenic or likely pathogenic variants in hereditary cancer predisposition genes (i.e., collection of positive controls) is required for above studies.
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A Study To Evaluate Non-Operative Management And Early Response Assessment In Rectal Cancer
Rochester, MN
The purpose of this study is to determine if the complete clinical response rate of patients with Stage I-IIIB (cT1-3, N0-1, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy is greater than 50%.
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Expanded Access Ga68 PSMA PET Imaging
Rochester, MN
The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.
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MMRC Horizon One Adaptive Platform Trial Evaluating Therapies In RRMM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
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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 Web-Based Physical Activity Intervention In Children And Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia In First Remission
Rochester, MN
The primary purpose of this study is to compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.
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Veliparib And Topotecan Hydrochloride In Treating Patients With Solid Tumors, Relapsed Or Refractory Ovarian Cancer, Or Primary Peritoneal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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Long-term Safety And Effectiveness Study For Participants With Advanced Tumors Who Are Currently On Treatment Or In Follow-up In A Pembrolizumab Trial
Rochester, MN
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.
Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.
Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this ...
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A Study To Assess The Safety, Tolerability, And Effectiveness Of KPT-9274 To Treat Patients Who Have Advanced Solid Malignancies Or Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.
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I-SPY TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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XmAb18968 (CD3-CD38) In Relapsed Or Refractory Acute Leukemia And T Cell Lymphoblastic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).
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A Study Of The Safety, Effectiveness And Maximum Tolerated Dose Of Oral PQR309 For Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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Targeted Alpha-Particle Therapy For Advanced SSTR2 Positive Neuroendocrine Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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Lead-212 PSV359 Therapy For Patients With Solid Tumors
Rochester, MN
Phase I/IIa image-guided, alpha-particle therapy study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.
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Study Of Tirabrutinib Vs Rituximab/Temozolomide For Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
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A 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 Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main 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. Study participation could last up to 10 years.
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A Study To Assess Efficacy And Safety Of Pembrolizumab With Or Without Sacituzumab Tirumotecan (MK- 2870) In Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Jacksonville, FL; Rochester, MN
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
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CATALINA-4: A Study To Investigate The Safety And Efficacy Of TORL-1-23 With Chemotherapy Given Before Initial Surgery In Women With Advanced Stage Ovarian Cancer
Rochester, MN
A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
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A Study To Investigate Subcutaneous Isatuximab In Combination With Weekly Carfilzomib And Dexamethasone In Adult Participants With Relapsed And/or Refractory Multiple Myeloma (SubQSA)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
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A Study Evaluating The Safety And Efficacy Of Targeted Therapies In Subpopulations Of 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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DiviTum Biomarker Assay For Efficacy In HR+ Metastatic Breast Cancer Patients
Jacksonville, FL
The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.
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Trial Of Nadofaragene Firadenovec Vs. Observation In Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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Phase I Study Of [177Lu]Lu-NNS309 In Patients With Pancreatic, Lung, Breast And Colorectal Cancers
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-130037 In Participants With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.
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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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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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Testing Teclistamab (TECVAYLI) In Combination With Iberdomide For Hard-to-Treat Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, ...
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Melanoma In-transit Tissue Bank And Molecular Analysis For Personalized Therapies
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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A Qualitative Study of Mayo Clinic Calabresi Scholars and Former Scholars
Rochester, MN
To learn from scholars and former scholars of the Mayo Clinic Cancer Center’s “Paul Calabresi Clinical Oncology (K12) Training Program” in their own words what helped them and what did not help them from a career development standpoint.
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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A Study Of LSTA1 When Added To Standard Of Care Versus Standard Of Care Alone In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma. The main questions it aims to answer are: -is the new drug plus standard treatment safe and tolerable -is the new drug plus standard treatment more effective than standard treatment.
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Testing Olaparib For One Or Two Years, With Or Without Bevacizumab, To Treat Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5\'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib ...
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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A Study Of JNJ-90009530 In Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma (R/r B-NHL)
Rochester, MN
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: -can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
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PRE-I-SPY Phase I/Ib Oncology Platform Program
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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DAREON™-9: A Study To Test How Well Different Doses Of BI 764532 Are Tolerated By People With Small Cell Lung Cancer When Taken Together With A Single Agent Chemotherapy
Jacksonville, FL
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study ...
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DNA And RNA Testing In Patients With Hereditary Cancer Syndromes
Rochester, MN
The purpose of this study is to evaluate the performance characteristics of RNA sequencing. To investigate the utility of RNA analysis in diagnosis of patients with cancer predisposition syndromes and collection of patient samples with pathogenic or likely pathogenic variants in hereditary cancer predisposition genes (i.e., collection of positive controls) is required for above studies.
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A Study To Evaluate Non-Operative Management And Early Response Assessment In Rectal Cancer
Rochester, MN
The purpose of this study is to determine if the complete clinical response rate of patients with Stage I-IIIB (cT1-3, N0-1, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy is greater than 50%.
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Expanded Access Ga68 PSMA PET Imaging
Rochester, MN
The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.
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MMRC Horizon One Adaptive Platform Trial Evaluating Therapies In RRMM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
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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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Veliparib And Topotecan Hydrochloride In Treating Patients With Solid Tumors, Relapsed Or Refractory Ovarian Cancer, Or Primary Peritoneal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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Long-term Safety And Effectiveness Study For Participants With Advanced Tumors Who Are Currently On Treatment Or In Follow-up In A Pembrolizumab Trial
Rochester, MN
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.
Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.
Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this ...
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A Study To Evaluate Web-Based Physical Activity Intervention In Children And Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia In First Remission
Rochester, MN
The primary purpose of this study is to compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.
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A Study To Assess The Safety, Tolerability, And Effectiveness Of KPT-9274 To Treat Patients Who Have Advanced Solid Malignancies Or Non-Hodgkin's Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.
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I-SPY TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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XmAb18968 (CD3-CD38) In Relapsed Or Refractory Acute Leukemia And T Cell Lymphoblastic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).
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A Study Of The Safety, Effectiveness And Maximum Tolerated Dose Of Oral PQR309 For Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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Targeted Alpha-Particle Therapy For Advanced SSTR2 Positive Neuroendocrine Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).
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Lead-212 PSV359 Therapy For Patients With Solid Tumors
Rochester, MN
Phase I/IIa image-guided, alpha-particle therapy study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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Study Of Tirabrutinib Vs Rituximab/Temozolomide For Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
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A 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 Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main 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. Study participation could last up to 10 years.
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A Long-Term Follow-Up Study Of Subjects Completing The AU-011-301(CoMpass) For Early Choroidal Melanoma
Rochester, MN
AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study
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A Study To Evaluate The Safety And Therapeutic Activity Of GI-102 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to evaluate the safety and tolerability of GI-102 to define the MTD and/or RP2D.
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A Study To Test How Well Different Doses Of BI 3706674 Are Tolerated By People With Advanced Cancer In The Stomach And Oesophagus
Scottsdale/Phoenix, AZ
The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone, and to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing.
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Ph1b/2 Dose-Escalation Study Of Entinostat With Pembrolizumab In NSCLC With Expansion Cohorts In NSCLC, Melanoma, And Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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Phase III Study Of Datopotamab Deruxtecan Versus Docetaxel In Previously Treated TROP2-positive Advanced Or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Eau Claire, WI; Jacksonville, FL; Rochester, MN
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
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A Study Of A Selective ERBB2 Inhibitor (CGT4255), In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.
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A Study To Investigate Ubamatamab With And Without REGN7075 In Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
This study will evaluate two study drugs called ubamatamab and REGN7075, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab.
The study is looking at:
* How well ubamatamab and REGN7075 works
* The side effects that ubamatamab and REGN7075 might cause
* How much ubamatamab and REGN7075 is in the blood at different times
* If the body makes antibodies to ubamatamab and/or REGN7075, this may cause the ubamatamab to not work as well
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A Study Of APG-3288 In Relapsed/Refractory Blood Cancers
Jacksonville, FL
This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed/refractory (R/R) hematologic malignancies.
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A Study Of BT5528 In Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 2 study for BT5528 in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment.
The drug, BT5528, is designed to find a specific protein called EphA2.
The main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive BT5528, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take ...
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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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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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Combination Treatment Therapy Approaches For The Treatment Of High-Risk Multiple Myeloma, REACH Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Understanding Treatment Preferences In Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this research is to understand how people with lymphoma make decisions about treatment and why. Study participation involves partaking in one virtual focus group session with a group of up to 8 people with lymphoma and up to two group moderators. Participants will be asked questions about what they prefer in a lymphoma treatment and how they have made decisions on treatment of their lymphoma in the past. Questions may be about past experiences as well as future hypothetical situations. We hope that what we learn from these discussions will help us to improve care for people ...
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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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A Study To Learn How Research Sites Successfully Recruited To A Geriatric Oncology Trial That Relied On Electronic Patient-reported Outcomes (EPRO)
Rochester, MN
The purpose of this study is to analyze how research sites successfully recruit geriatric oncology patients using electronic-reported patient outcomes.
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Aliya™ Pulsed Electric Fields (PEF) Delivered Prior To Standard Of Care Treatment For Advanced Cancer
Jacksonville, FL; Rochester, MN
The purpose of this early feasibility study (EFS) is to evaluate the safety of delivering Aliya pulsed electric fields ablation in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
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Study 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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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 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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Clinical Study Of Ivonescimab For First-line Treatment Of Metastatic NSCLC Patients
Jacksonville, FL; Rochester, MN
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
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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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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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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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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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Study To Improve Health-related Quality Of Life (HRQOL) In Black Prostate Cancer Patients (CaPQoL) Through Whole Person Survivorship Care
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.
Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, ...
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Pragmatic Comparative Clinical Trial To Determine Optimal Initial Therapy For Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed Multiple Myeloma.
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Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia
No Locations
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Study 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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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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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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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 Master Protocol To Evaluate The Long-Term Safety Of (LY3527727) Pirtobrutinib
Rochester, MN
The purpose of this study is to evaluate the long-term safety of pirtobrutinib.
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A Study To Evaluate ARV-806 In Adults With Advanced Cancer That Has The KRAS G12D Mutation
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is ...
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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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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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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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Study Of The Safety, Pharmacokinetics And Efficacy Of EDO-S101, In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
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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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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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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A Trial Of Casdozokitug In Combination With Toripalimab Plus Bevacizumab In Participants With Unresectable And/or Locally Advanced Or Metastatic Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
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Evaluate REC-4881 In Participants With Familial Adenomatous Polyposis (FAP)
Scottsdale/Phoenix, AZ; Rochester, MN
This is a multicenter, two-part trial in participants with FAP.
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A First-in-Human Study Of MEN2312 In Adults With Advanced Breast Cancer
Rochester, MN
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
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Prospective Pancreatic Cancer Precision Oncology Treatment Outcomes Registry
Rochester, MN
The purpose of this study is to establish a prospective, longitudinal registry of patients with pancreatic cancer receiving clinician-directed therapy in routine practice, including FDA-approved agents used off-label or even investigational agents under a single-patient IND, in order to characterize real-world treatment patterns, effectiveness, and safety and to evaluate how clinical and tumor features, including molecular characteristics, relate to outcomes.
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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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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 To Evaluate The Efficacy Of Cemsidomide + Dexamethasone In Participants With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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A Study of GDC-0449 and Erlotinib Hydrochloride, with or without Gemcitabine Hydrochloride for Treating Patients with Metastatic Pancreatic Cancer or Solid Tumors that cannot be Removed by Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449, and either with or without gemcitabine hydrochloride, for the treatment of patients who have metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with ...
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Evaluation Of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib In Locally Advanced Or Metastatic ER+/HER2- Breast Cancer With An ESR1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 ...
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Enfortumab Vedotin And Pembrolizumab With Cystectomy And/or Ureterectomy For Locally Advanced Or Metastatic Bladder And Upper Urothelial Tract Cancer, CAST-AI Trial
Rochester, MN
This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It ...
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A Study Of Tolododekin Alfa (ANK-101) In Combination With An Anti-PD-1/PD-L1 Antibody In Participants With Advanced Non-Small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
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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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ASPEN-09: A Study Of Evorpacept In Combination With Anti-cancer Therapies In Advanced / Metastatic Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:
* Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.
* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.
* Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other ...
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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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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 efficacy and safety of tebentafusp-based regimens, including 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 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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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 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 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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Virtual Reality Intervention To Improve Psychological Symptom Burden For Cancer Patients Undergoing Treatment
Jacksonville, FL
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to ...
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A Study to Review the Safety of Familial Adenomatous Polyposis/Erlotinib Study
Scottsdale/Phoenix, AZ
The purpose of this study is to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, who provide consent for the review of their medical records. There have been reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. A review of literature found insufficient data to determine whether or not there is a longer term safety risk to the participant in MAY2016-07-01.
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Study Of 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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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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A Phase II Clinical Trial Comparing The Efficacy Of RO7198457 Versus Watchful Waiting In Patients With CtDNA-positive, Resected Stage II (High Risk) And Stage III Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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Comparing Rituximab And Mosunetuzumab Drug Treatments For People With Low Tumor Burden Follicular Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with ...
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A 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 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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Neoadjuvant Dual Checkpoint Blockade With PD1 And LAG-3 Inhibition In Resectable Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is toassess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥50%, as measured by rate of major pathologic response (MPR).
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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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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 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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Impact Of Restricted Medication Access On Care Of Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to evaluate differences in time to fill lenalidomide, pomalidomide and thalidomide (iMiDs) prescribed by a health-system provider (HSP) when the health-system specialty pharmacy is either 1) in both the limited distribution (LDD) network and payor network, 2) in the LDD network but payor lock out, or 3) not in the LDD network. To accomplish this aim, we will perform a mixed methods study using quantitative data to evaluate time to medication access and qualitative data using surveys to assess patient and provider experiences.
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PRT3789 Monotherapy And In Combo W/Docetaxel In Participants W/Advanced Or Metastatic Solid Tumors W/SMARCA4 Mutation
Jacksonville, FL; Rochester, MN
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
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A Phase Ⅲ Study Of Rilvegostomig In Combination With Fluoropyrimidine And Trastuzumab Deruxtecan As The First-line Treatment For HER2-positive Gastric Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD-L1 CPS ≥ 1. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
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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 To Evaluate Zanubrutinib To Treat Patients With B-cell Malignancies
Rochester, MN
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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Efficacy And Safety Of Nemtabrutinib (MK-1026) In Participants With Hematologic Malignancies (MK-1026-003)
Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
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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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Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Rochester, MN
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial will determine whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources.
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A Study Of X4P-001 In Patients With Advanced Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the study is to test different doses of X4P-001 given alone and in combination with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.
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A Study Of SC-007 In Subjects With Advanced Cancer
Rochester, MN
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
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A Trial To Find Out If REGN5678 Is Safe And How Well It Works Alone Or In Combination With Cemiplimab For Adult Participants With Metastatic Castration-Resistant Prostate Cancer And Other Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at ...
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Sequential Treatments Or Combinations Including Dasatinib, Quercetin, Fisetin And/or Temozolomide For The Treatment Of Previously Treated Glioma With Residual Disease
Rochester, MN
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They ...
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A 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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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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Study Of AB598 Monotherapy And Combination Therapy In Participants With Advanced Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.
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A Study To Analyze Symptoms And Quality Of Life Issues In Women Living With Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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A Study To Evaluate Tucatinib And Trastuzumab In Solid Tumors With HER2 Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
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A Phase 3, Randomized, Open-label, Controlled Study Comparing The Efficacy And Safety Of Zanidatamab To Trastuzumab, Each In Combination With Physician’s Choice Chemotherapy, For The Treatment Of Participants With Metastatic HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.
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A Study Of BH-30643 In Subjects With Locally Advanced Or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the ...
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A First-in-Human Study Of BG-C137, An Anti-FGFR2b Antibody Drug Conjugate, In Participants With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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Study To Evaluate The Efficacy And Safety Of Ersodetug In Patients With Inadequately Controlled Hypoglycemia Due To Tumor-Associated Hyperinsulinism
Rochester, MN
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in participants with inadequately controlled hypoglycemia due to islet-cell (insulinomas) and non-islet cell tumor hyperinsulinism.
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Study Of Lurbinectedin In Combination With Doxorubicin Versus Doxorubicin Alone As First-line Treatment In Participants With Metastatic Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
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Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
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Saruparib (AZD5305) Plus Camizestrant Or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy Or Plus Camizestrant In HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, Or PALB2m Advanced Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
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Patient Reported Outcomes For The Integrative Oncology Clinic
Rochester, MN
The purpose of this study is to obtain baseline patient-reported outcomes (PROs) for diet/exercise, sleep, stress, sexual health, pain interference, and overall quality of life (QOL).
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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 of 2 cohorts: ...
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Study Of Datopotamab Deruxtecan Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
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Daratumumab For Chemotherapy-Refractory Minimal Residual Disease In T Cell ALL
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL in hematologic morphologic complete remission or complete remission with incomplete hematologic recovery. The secondary objectives include; evaluation of morphologic relapse free survival (RFS), evaluation of overall survival (OS), assessment of the the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase, assessment of adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL, and assessment of flow cytometry based MRD status on Day 64 of ...
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A Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Anti-tumor Activity Of CBI-1214 T Cell Engager In Participants With Advanced Or Metastatic MSS/MSI-L Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
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Phase 3 Study Of T-DXd And Rilvegostomig Versus SoC In Advanced HER2-expressing Biliary Tract Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
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Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Jacksonville, FL
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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A Study 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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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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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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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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A Study To Compare Standard Therapy To Treat Hodgkin Lymphoma To The Use Of Two Drugs, Brentuximab Vedotin And Nivolumab
Jacksonville, FL; 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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Equity Of Cancer Screening And Follow-up For Lung Cancer
Rochester, MN
The purpose of this study is to elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: (1) Characterize the delivery of evidence-based interventions (EBIs) for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening (LCS) at multiple levels of influences; (2) Identify potentially modifiable care gaps across the LCS continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients ...
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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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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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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; Jacksonville, FL; La Crosse, WI; Rochester, MN
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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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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A Study Of SPX-303, A Bispecific Antibody Targeting LILRB2 And PD-L1 In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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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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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 Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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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 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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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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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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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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Study Of Safety, Pharmacokinetic And Efficacy Of APG-5918 In Advanced Solid Tumors Or Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, open-label, Phase 1 study that will be conducted in two parts. Part 1 is the dose escalation of APG-5918. Part 2 is the dose expansion of APG-5918.
APG-5918 will be administered orally. Patients will be treated in 28-day cycles.
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A Study Of NT-175 In Adult Participants With Advanced Malignancies That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
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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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BBO-11818 In Adult Subjects With KRAS Mutant Cancer
Scottsdale/Phoenix, AZ
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
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Gleolan For Visualization Of Newly Diagnosed Or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Jacksonville, FL; 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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Dual BET And CBP/p300 Inhibitor In Patients With Targeted Advanced Solid Tumors And Hematological Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
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A Study To Evaluate ALN-BCAT In Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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A Study Of LY4152199 In Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Rochester, MN
The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
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Using Virtual Community Health Workers To Connect Patients To Cancer Research Studies
Jacksonville, FL
The purpose of this study is to quantitatively examine, via a post-test only survey, a tailored intervention utilizing virtual human technology (VHT) to improve communication with rural and ethnic/racial minority patients and their willingness to participate in clinical research as an ultimate means to increase the diversity of NCI-sponsored clinical trials (CCTs).
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Study Of INBRX-109 In Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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A 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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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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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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Metastatic Leiomyosarcoma Biomarker Protocol
Jacksonville, FL; Rochester, MN
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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A Study Of Digital Health Technologies For Detecting Cancer Treatment-Related Cardiotoxicities
Scottsdale/Phoenix, AZ
The purpose of this study is to detect cardiotoxicity early in cancer patients using ML and wearables, potentially reducing CVD impact and improving long-term survival and quality of life.
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A Study To Evaluate Oncologic Outcomes And Quality Of Life In Sinonasal Cancer Patients
Rochester, MN
This is a multi-site study with several other leading centers studying sinonasal cancers. The purpose of this study is to gain a better understanding of the treatment and significant morbidity associated with sinonasal cancer and identify the impact this disease has on quality of life. In addition, several additional endpoints will focus on survival and optimal treatment strategies. Additional components will also included genomic and molecular analysis of tumor tissue as we search for novel targets for therapy.
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A Study Of JNJ-69086420, An Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (HK2) For Advanced Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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A Study To Evaluate Safety, PK, PD And Efficacy Of AZD5492, A T Cell-engaging Antibody Targeting CD20 In Subjects With R/R B-Cell Malignancies.
Rochester, MN
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
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Study Of KITE-363 Or KITE-753 In Participants With Relapsed And/or Refractory B-cell Lymphoma
Jacksonville, FL; Rochester, MN
The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
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Phase 1 Trial Of ST-001 NanoFenretinide In Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ
This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).
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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 (LiGeR-HN2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a phase 3 open-label, randomized, controlled, multicenter study 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
Scottsdale/Phoenix, AZ; Jacksonville, FL; 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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Phase 1/2 Study Of Silevertinib (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 silevertinib (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 (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles.
Phase 1 enrollment is now complete. Phase 2 is ...
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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Clinicopathological and Molecular Characteristics Associated With Acquired Resistance to Kinase Inhibitors in Thyroid Cancer
Rochester, MN
Objectives
The purpose of this study is to understand the clinicopathological and molecular characteristics associated with acquired resistance to kinase inhibitors in thyroid cancer.
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International Hepatobiliary Neoplasia Registry and Biorepository
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This study is being done to:
1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.
2. A second purpose of this study is to obtain blood and tissue samples from participants ...
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Gastrointestinal-Related Cancers and Diseases
Rochester, MN
The purpose of applying to the Institutional Review Board (IRB) for the collection of GI-related tissue is to enable comprehensive molecular investigations into the mechanisms underlying gastrointestinal cancers and diseases.
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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A Study Of CLN-619 (Anti-MICA/MICB Antibody) In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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PLX038 For The Treatment Of Metastatic Ovarian, Peritoneal, And Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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Interviews About Social Determinants Of Health In Southeast Asian Americans To Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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CJNJ-67652000 And Prednisone For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer And SPOP Gene Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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A Study Of Oral LOXO-305 In Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Or Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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Study Assessing Activity Of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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A Study Of MK-1026 In Patients With Selected Hematologic Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of Ziftomenib, An Oral Menin Inhibitor, In Combination With Imatinib In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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A Trial To Assess Effectiveness And Safety Of Octreotide Subcutaneous Depot In Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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A Study To Test DSP107 In Combination With Atezolizumab In Comparison With Fruquintinib As A New Treatment For Colorectal Cancer.
Jacksonville, FL
This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
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Study Of AZD5863 In Adult Participants With Advanced Or Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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A Study To Evaluate Feasibility Of In Vivo Sensitivity Screen Using Direct Tumor Microinjection And FDG-PET In Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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VS-6766+Abema+Fulv In Met HR+/HER- BC
Rochester, MN
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
The names of the study drugs involved in this study are:
VS-6766
Abemaciclib
Fulvestrant
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A Phase 1 Study Of 177Lu-IM-3050 In Participants With Advanced Cancer
Rochester, MN
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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Ulixertinib In People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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Investigating Memory And Physical Activity After Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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Study To Evaluate The Efficacy And Safety Of [177Lu]Lu-DOTA-TATE In Patients With Grade 1 And Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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A Digital Treatment Platform For The Delivery Of Home-Based Sequential Therapy In Patients With Glioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while ...
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JNJ-90301900 (NBTXR3) Activated By Radiotherapy With Or Without Cetuximab In LA-HNSCC
Jacksonville, FL
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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RLP
Albert Lea, MN; Mankato, MN; Rochester, MN
The purpose of this study is to determine feasibility as measured by total number of patients enrolled in 1 year, adherence (75% of the enrolled participants will complete at least 4 of the 6 RLP sessions). Determine acceptability as measured by satisfaction with the research process, as measured by the Was It Worth It (WiWi 2.0) questionnaire. The WiWi 2.0 was developed to evaluate patient's satisfaction with cancer clinical trial participation. Results are reported as individual items.
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML).
The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the ...
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Study Of IBI363 In Subjects With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.
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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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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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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer
Jacksonville, FL
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may ...
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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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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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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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ICCaRE Consortium Pilot Project 1: Feasibility Of A Point Of Prostate Cancer Diagnosis Intervention For Newly Diagnosed Black Men
Jacksonville, FL
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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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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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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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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A Study Evaluating The Efficacy And Safety Of Cevostamab In Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography For Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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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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Pilot Study Of Antineoplastic
Rochester, MN
The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.
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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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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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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
Rochester, MN
AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients ...
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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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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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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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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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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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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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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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A Study To Investigate The Safety And Efficacy Of SAR446523 Injected Subcutaneously In Adult Participants With Relapsed/Refractory Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming ...
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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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A Study To Evaluate The Adverse Events, And Efficacy Of Intravenous (IV) Of Telisotuzumab Adizutecan In Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...
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Testing The Effects Of Novel Therapeutics For Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a ...
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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 Phase 1 Study Of XL309 (ISM3091) Alone And In Combination In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.
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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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Comprehensive Universal Repository For Oncology Exploration
Jacksonville, FL
The primary goal of this project is to establish an overarching Mayo Clinic Florida (MCF) Biobank program to collect, annotate, store, and distribute biospecimens from individuals presenting to MCF for the diagnosis or management of cancers including but not limited to gastrointestinal (GI)/pancreatic cancers, breast cancer, lung cancer, melanoma and Merkel cell carcinoma, and brain cancer.
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A Study Comparing JNJ-79635322 And Teclistamab In Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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ADG126 In Combination With Pembrolizumab In Patients With Advanced/Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN
This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
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Phase 3 Study Of Daraxonrasib (RMC-6236) In Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
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Study Of The Theranostic Pair RYZ811 (Diagnostic) And RYZ801 (Therapeutic) To Identify And Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
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Phase 2 Study To Evaluate Safety And Efficacy Of Cretostimogene Grenadenorepvec In NMIBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer
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A Dose-Escalation And Expansion Study Of Tacabrutideg (BGB-16673) In Participants With B-Cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
No Locations
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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A Study Of Intravesical BCG In Combination With ALT-803 In Patients With Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
For Cohort A, the purpose of this study is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate using cystoscopy, confirmatory bladder biopsy, and urine cytology. For Cohort B, the purpose is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy, and urine cytology.
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A Registry For People With Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine 3- and 5-year disease-free survival (DFS) among patients undergoing pulmonary segmentectomy for lung cancer. Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
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Experiences W/ & Attitudes Towards Immune Chckpt Inhibitors In NSCLC Patients Single Center Survey Based Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
This study evaluates patient satisfaction with receiving intravenous (IV) and/or subcutaneous (SC) immunotherapy and to assess patient preference for IV immunotherapy administration versus SC immunotherapy administration either at the hospital or at home.
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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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ResQ132EX-NMIBC: Expanded Access Use Of Recombinant Bacillus Calmette-Guerin In Nonmuscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).
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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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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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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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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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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 Collaborative Intervention For Improving Cancer Pain Management In Rural And Hispanic Cancer Survivors (ASCENT)
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially well matched for these patients, and can ...
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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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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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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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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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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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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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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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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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Wild-Type Reovirus In Combination With Sargramostim In Treating Younger Patients With High-Grade Relapsed Or Refractory Brain Tumors
Rochester, MN
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
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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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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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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
Rochester, MN
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib ...
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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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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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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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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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Etiology, Prevention And Therapy Navigation Of Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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A Study of Using Bortezomib and Combination Chemotherapy in Treating Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Rochester, MN
This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
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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
Eau Claire, WI
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 oxaliplatin, leucovorin ...
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A Study Of DCC-2618 Vs. Sunitinib In Advanced GIST Patients After Treatment With Imatinib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
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Tele-Medicine In An Advanced Prostate Cancer Clinic
Rochester, MN
The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.
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A Trial Of Pirtobrutinib (LOXO-305) Plus Venetoclax And Rituximab (PVR) Versus Venetoclax And Rituximab (VR) In Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Radiotherapy To Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs?
This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.
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Combination Therapy Of Acalabrutinib, Venetoclax And Durvalumab To Treat Richter Transformation
Rochester, MN
The purpose of this study is to determine if the drug combination of acalabrutinib, durvalumab, and venetoclax will work to treat Richter’s transformation, and what doses of these drugs are safe for people to take. We also want to learn about the side effects of this combination. All study subjects will receive acalabrutinib, durvalumab, and venetoclax. Acalabrutinib is FDA approved for treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Durvalumab is FDA approved for treatment in lung cancers including non-small cell lung cancer and small cell lung cancer. Venetoclax is FDA approved for the treatment of CLL and SLL. ...
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A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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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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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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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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A Study To Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed And/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Rochester, MN
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
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Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
Rochester, MN
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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A Global Study To Assess The Effects Of Durvalumab + Domvanalimab Following Concurrent Chemoradiation In Participants With Stage III Unresectable NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following definitive platinum-based concurrent chemoradiation therapy (cCRT).
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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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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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Phase 1-2 Study Of Low Dose ASTX727 (ASTX727 LD) In Lower Risk Myelodysplastic Syndromes
Jacksonville, FL; Rochester, MN
The purpose of this study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 Myelodysplastic Syndromes (MDS). This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.
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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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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 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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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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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Panitumumab, Regorafenib, Or TAS-102, In Treating Patients With Metastatic And/or Unresectable RAS Wild-Type Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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 Multicenter Study In Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence For Rapid Lung Cancer Detection - The ON-SITE Study
Jacksonville, FL
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
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Associations Between Chemotherapy-Induced Nausea In Patients With Genitourinary Cancer And Changes In Gut Microbiome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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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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ONC201 In H3 K27M-mutant Diffuse Glioma Following Radiotherapy (The ACTION Study)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study to Evaluate Immune Response Changes to Ovarian Cancer During Chemotherapy
Rochester, MN
The study will determine whether the type and number of immune cells (white blood cells) in ovarian cancer tumors after initial chemotherapy impacts ovarian cancer patient outcomes.
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GATE1: A Multicenter Phase II Study Of Pirtobrutinib, Rituximab And Venetoclax Combination Therapy For Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, MN
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
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A Study To Compare Three Chemotherapy Regimens For The Treatment Of Patients With Newly- Diagnosed Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib, and to determine how well they work in treating patients with newly-diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine 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 rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the ...
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A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer
Albert Lea, MN; Rochester, MN
The purpose of this study is to evaluate how well letrozole, with or without paclitaxel and carboplatin, works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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Changes In Blood Components In Patients With Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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A Study To Evaluate The Efficacy And Safety Of Golcadomide In Combination With Rituximab In Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
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Confirmatory Study Of Topical HyBryte™ Vs. Placebo For The Treatment Of CTCL (FLASH2)
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
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A Study Evaluating Temozolomide Vs. Temozolomide And Olaparib For Advanced Pheochromocytoma And Paraganglioma
Rochester, MN
The purpose of this study is to determine how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. 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 ...
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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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Study Of Safety And Efficacy Of Iberdomide (CC-220) And CC-99282 Combined With R-CHOP To Treat Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of Part 1 of this study is to define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-220 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone given in 21-day treatment cycles (R-CHOP-21) and CC99282 in combination with R-CHOP-21 in subjects with previously untreated, high risk (International Prognostic Index [IPI] 3 to 5), a-BCL.
The primary objective of Part 2 of this study is to further evaluate the safety and tolerability associated with CC-220 and CC-99282 at the RP2D in combination with R-CHOP-21 in subjects with previously untreated, high-risk (IPI 3 to 5), a-BCL.
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Comparison Of Standard Care With Radiation And Medicinal Therapy Vs Radiation Alone For Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.
This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular ...
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Testing The Addition Of An Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery To The Usual Surgery Alone For Treating Advanced Skin Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may ...
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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 temozolomide, 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 or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy ...
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A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I), and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).
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Duvelisib And Nivolumab For The Treatment Of Stage IIB-IVB Mycosis Fungoides And Sezary Syndrome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in ...
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Turkey Tail Mushroom For Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.
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A Phase 1/2 Trial Of Gemcitabine Plus Nab-paclitaxel With Or Without FG-3019 As Neoadjuvant Chemotherapy In Locally Advanced, Unresectable Pancreatic Cancer
Jacksonville, FL
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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A Phase 1/2 Trial Of Gemcitabine Plus Nab-paclitaxel With Or Without FG-3019 As Neoadjuvant Chemotherapy In Locally Advanced, Unresectable Pancreatic Cancer
Jacksonville, FL
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB ...
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Decitabine In Combination With Standard Of Care Therapy For The Treatment Of Surgically Resectable HPV-Negative Head And Neck Cancer
Jacksonville, FL
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower ...
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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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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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Testing The Addition Of M3814 (Peposertib) To Radiation Therapy For Patients With Advanced Head And Neck Cancer Who Cannot Take Cisplatin
Scottsdale/Phoenix, AZ
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
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A Study To Evaluate 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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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
Jacksonville, FL; Rochester, MN
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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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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Lenalidomide And Low-Dose Dexamethasone In Patients With Previously Treated Multiple Myeloma And Kidney Dysfunction
Scottsdale/Phoenix, AZ; Rochester, MN
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used ...
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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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A Study to Assess AC220 Given in Combination with Induction and Consolidation Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML)
Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
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A Study To Evaluate MM-151, Nal-IRI, 5-FU, And Leucovorin For RAS/RAF Wild-Type Metastatic Colorectal Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.
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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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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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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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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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Study Of Carboplatin And Mirvetuximab Soravtansine In First-Line Treatment Of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube Or Primary Peritoneal Cancer
Rochester, MN
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive ...
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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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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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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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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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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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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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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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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
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A Study To Evaluate Duloxetine To Prevent Oxaliplatin-Induced Peripheral Neuropathy In Patients With Stage II-III Colorectal Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN
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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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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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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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN
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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Anti-VEGF Gene Therapy Trial For Vestibular Schwannoma
Rochester, MN
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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MC250412 Phase 2B Study To Determine Efficacy Of HRX215, A First Generation MKK4 Inhibitor Drug, In Improving Regeneration Of The Remnant Liver After Portal Vein Embolization (PVE) Of Colorectal Liver Metastasis (CRLM)
Rochester, MN
Colorectal cancer (CRC) is a malignant disease of the colon or rectum and represents the third most frequently diagnosed cancer in both men and women. Over the course of their disease, approximately half of all CRC patients will develop colorectal liver metastases (CRLM). (Bray et al., 2024)
Currently, liver resection remains the only potentially curative option for patients with CRLM. However, only 10% to 30% of patients present with disease that is considered resectable. In the United States alone, more than 76,000 new cases of CRLM were projected for 2023, yet only an estimated 23,000 of these ...
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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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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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Ascorbic Acid And Chemotherapy For The Treatment Of Relapsed Or Refractory Lymphoma, CCUS, And Chronic Myelomonocytic Leukemia
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). 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 kill more cancer cells.
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Surgery With Or Without Neoadjuvant Chemotherapy In High Risk RetroPeritoneal Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
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Symbiotic-GI-03: A Study To Learn About The Study Medicine Called PF-08634404 In Combination With Chemotherapy In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have colorectal cancer that has spread to other parts of your body.
* Be in good enough health to receive study treatment.
* Should not be ...
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A Study Of Advanced Magnetic Resonance Imaging For Detection And Characterization Of Prostate Cancer
Rochester, MN
The purpose of this study is to evaluate and validate our novel 3D DWI for detection and characterization of prostate cancer.
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
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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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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, And Elotuzumab, Pomalidomide, And Dexamethasone Or Pomalidomide, Bortezomib, And Dexamethasone In Participants With Relapsed Or Refractory Myeloma Who Have Received An Anti-CD38 Antibody And Lenalidomide
Rochester, MN
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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Evaluating Bladder CARE™, A New Non-Invasive Urine Test, For Bladder Cancer Detection In Inconclusive Cases
Rochester, MN
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:
• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?
Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), ...
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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 Compare Docetaxel/Prednisone to Docetaxel/Prednisone Combined with OGX-011 in Men with Prostate Cancer
Rochester, MN
The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone.
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A Study to Assess Anxiety Associated with Outpatient Visits in Pediatric Oncology Patients
Rochester, MN
The purpose of this study is to assess baseline anxiety experienced by children and their parents/guardians associated with outpatient visits in pediatric oncology. Assess coping mechanisms used by children and their parents/guardians to alleviate the anxiety associated with outpatient visits in pediatric oncology.
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Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal ...
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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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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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A Long Term Follow Up Of Mammography Screening
Rochester, MN
The purpose of this study is to execute a long-term retrospective observational cohort study of women who underwent screening mammography (defined as digital mammography or tomosynthesis).
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S1406 A Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...
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Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Scottsdale/Phoenix, AZ
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
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Testing The Use Of Ado-Trastuzumab Emtansine Compared To The Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) Or Trastuzumab Deruxtecan For Recurrent, Metastatic, Or Unresectable HER2-Expressing Salivary Gland Cancers
Rochester, MN
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 ...
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Reduced Dose Hypofractionated Radiotherapy For Indolent Non-hodgkin Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, 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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Colorectal Cancer Screening/Microbiome Collection
Jacksonville, FL
The purpose of this study is to evaluate the integration of cancer genetic testing into a cancer clinical practice aimed towards patients of various ethnic populations in Arizona and Florida – including, but not limited to, Hispanic/Latino, Native American/Alaskan, African American, and Asian by self-report.
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A Study Of Catequentinib, Anlotinib In Metastatic Or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma And Synovial Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AL3818 (catequentibub, anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
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A 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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Gene Therapy For B-Cell Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (ALL).
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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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Three-Dimensional Ultrasound in the Determination of Tumor Volume and Myometrial Invasion in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.
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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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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Scottsdale/Phoenix, AZ; 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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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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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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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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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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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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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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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 Standard Systemic Therapy With Or Without Definitive Treatment In Treating Participants With Metastatic Prostate Cancer
Scottsdale/Phoenix, AZ; La Crosse, WI; 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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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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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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Assess Dexamethasone-induced Genes In Circulating Tumor Cells
Rochester, MN
Concerns about the use of DEX as a standard anti-emetic for women with ovarian cancer promoted us to examine its impact on drug sensitivity. Assessment in both cell lines (in vitro) and patient-derived xenograft models (in vivo) shows that, DEX administration decreases platinum induced tumor killing. This effect is observed in models that express GcR and is likely through the activation of genes modulating platinum sensitivity. Importantly, mechanistic studies conducted in our lab confirm the induction of several proteins involved in metal-binding and regulation of cell death. As a result, there is substantial interest in being able to ...
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Testing The Addition Of Paclitaxel Administered Into The Abdominal Cavity Combined With Chemotherapy For Patients With Gastric Cancer Spread To The Abdominal Cavity
Rochester, MN
This study is being done to answer the following questions:
Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most ...
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Gemcitabine And Cisplatin As Neoadjuvant Chemotherapy In Patients With High-Grade Upper Tract Urothelial Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
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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 Artificial Intelligence Virtual Assistant For Breast Cancer Patients And Survivors
Jacksonville, FL
The purpose of this study is to determine the effects of a novel AIVA for breast cancer patients and survivors on health care utilization compared to the control group. Our working hypothesis is that breast cancer patients and survivors undergoing reconstructive breast surgery, who leverage our novel AIVA tool, will have reduced clerical resource utilization compared to those receiving standard of care postoperative instructions alone
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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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A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.
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A Study To Investigate The Safety And Tolerability Of Ziftomenib In Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, Or 7+3+Quizartinib In Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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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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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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A Phase 2 Study Of CPI-0610 With And Without Ruxolitinib In Patients With Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of trhis study is to evaluate CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm).
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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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Group Meaning-Centered Psychotherapy For The Improvement Of Wellbeing In Caregivers Of Patients With Advanced Cancer
Jacksonville, FL; Rochester, MN
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual ...
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Clinical Trial Of The ATM-Inhibitor WSD0628 In Combination With Radiation Therapy For Recurrent Brain Tumors
Rochester, MN
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Rochester, MN
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with ...
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A Study To Learn About The Medicine Ponsegromab In Adults With Cancer Of The Pancreas Which Has Spread And Caused Significant Body Weight Loss And Fatigue
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
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Endometrial Cancer/Endometrial Atypical Hyperplasia With An AI-based Classifier In Transvaginal Ultrasound In Patients With Post-Menopausal Bleeding
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Testing The Addition Of An Anti-Cancer Drug, Cabozantinib To The Immunotherapy Drug Cemiplimab (REGN2810), In Adolescents And Adults With Advanced Adrenocortical Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells ...
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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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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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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 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 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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A Study To Evaluate Duloxetine To Prevent Oxaliplatin-Induced Peripheral Neuropathy In Patients With Stage II-III Colorectal Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN
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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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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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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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN
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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Anti-VEGF Gene Therapy Trial For Vestibular Schwannoma
Rochester, MN
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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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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MC250412 Phase 2B Study To Determine Efficacy Of HRX215, A First Generation MKK4 Inhibitor Drug, In Improving Regeneration Of The Remnant Liver After Portal Vein Embolization (PVE) Of Colorectal Liver Metastasis (CRLM)
Rochester, MN
Colorectal cancer (CRC) is a malignant disease of the colon or rectum and represents the third most frequently diagnosed cancer in both men and women. Over the course of their disease, approximately half of all CRC patients will develop colorectal liver metastases (CRLM). (Bray et al., 2024)
Currently, liver resection remains the only potentially curative option for patients with CRLM. However, only 10% to 30% of patients present with disease that is considered resectable. In the United States alone, more than 76,000 new cases of CRLM were projected for 2023, yet only an estimated 23,000 of these ...
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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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Ascorbic Acid And Chemotherapy For The Treatment Of Relapsed Or Refractory Lymphoma, CCUS, And Chronic Myelomonocytic Leukemia
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). 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 kill more cancer cells.
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Surgery With Or Without Neoadjuvant Chemotherapy In High Risk RetroPeritoneal Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
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A Study Of Advanced Magnetic Resonance Imaging For Detection And Characterization Of Prostate Cancer
Rochester, MN
The purpose of this study is to evaluate and validate our novel 3D DWI for detection and characterization of prostate cancer.
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Symbiotic-GI-03: A Study To Learn About The Study Medicine Called PF-08634404 In Combination With Chemotherapy In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have colorectal cancer that has spread to other parts of your body.
* Be in good enough health to receive study treatment.
* Should not be ...
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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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Virtual Dignity Therapy For Palliative Care Patients With Advanced Cancer
Rochester, MN
The purpose of this study is to determine if it is feasible to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer and whether the intervention is beneficial in terms of improvement in distress, patient dignity, and quality of life.
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A Study 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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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Rochester, MN
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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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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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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NRG-GY012 “A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, And The Combinations Of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5356 (Capivasertib) In Women With Recurrent, Persistent Or Metastatic Endometrial Cancer. A Multi-Arm Trial For Women With Recurrent Or Persistent Endometrial Cancer”
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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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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GPS Compared With BAT In AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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A Study 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
This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.
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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 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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Adding The Immunotherapy Drug Cemiplimab To Usual Treatment For People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy And Immunotherapy (An Expanded Lung-MAP Treatment Trial)
Rochester, MN
This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor ...
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A Study to Explore MRI to Stage Bladder Cancer
Jacksonville, FL
The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.
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Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy
Rochester, MN
The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
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A Study To Evaluate Artificial Intelligence-driven Assistance For Treatment Planning In Radiation Oncology
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.
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AKT Inhibitor MK2206, Combined with Bendamustine Hydrochloride, and Rituximab for Treating Patients who have Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
The purpose of this study is is to assess the side effects and best dose of akt inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab, and to see how well they work in treating patients with treatment resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, ...
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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Durvalumab+/- Tremelimumab In Combination With Platinum Based Chemotherapy In Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
Scottsdale/Phoenix, AZ
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer.
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Bendamustine Hydrochloride And Rituximab With Or Without Bortezomib Followed By Rituximab With Or Without Lenalidomide In Treating Patients With High-Risk Stage II, Stage III, Or Stage IV Follicular Lymphoma
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and ...
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Comparing Retreatment Of 177Lu-DOTATATE PRRT Versus Everolimus In Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is tol compare the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable).
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A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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Analysis Of Live Tumor Fragments Of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Safety And Efficacy Study Of Treatment Combinations With And Without Chemotherapy In Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
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A Study To Evaluate Contouring Organs At Risk For Treatment Planning
Rochester, MN
The purpose of this study is to determine: if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing. These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow.
Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations ...
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Cervical Cancer Screening Among Populations With Health Disparities
Rochester, MN
The purpose of this study is to conduct a survey of Somali and Hispanic women to ascertain personal, cultural, and structural barriers to CCS and assess the acceptability, and appropriateness of community engaged and community-based strategies to increase screening.
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A Study To Test The Addition Of The Drug Cabozantinib To Chemotherapy In Patients With Newly Diagnosed Osteosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill ...
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Fucoidan For Preventing Chemotherapy-Related Fatigue In Patients With Gastrointestinal Or Gynecological Cancer
Scottsdale/Phoenix, AZ
This clinical trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI) or gynecological (GYN) cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.
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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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DESTINY-Endometrial01: A Phase III Study Of Trastuzumab Deruxtecan Plus Rilvegostomig Or Pembrolizumab As First-Line Treatment Of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer
Rochester, MN
DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
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A Study To Evaluate The Addition Of Immunotherapy Into Adjuvant Therapy For Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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A Study 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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Study Of Pembrolizumab With Ipilimumab Or Placebo In Participants With Untreated Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
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A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab
Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
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A Study to 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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Phase 3 Study Of PDS0101 And Pembrolizumab In HPV16+ Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.
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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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Phase 2 Trial Of Voyager V1 In Combination With Cemiplimab In Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)
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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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Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
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A Study 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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Study Of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) In Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy In Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study To Evaluate Whether Participants With Melanoma Prefer Subcutaneous Vs Intravenous Administration Of Nivolumab And Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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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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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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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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IMC-F106C Regimen Versus Nivolumab Regimens In Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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A Study To Evaluate 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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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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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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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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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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A Study To Evaluate DS-1062a Combined With Pembrolizumab In Advanced Or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood In Patients With Relapsed And Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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LEGEND Study: EG-70 In NMIBC Patients BCG-Unresponsive And High-Risk NMIBC Incompletely Treated With BCG Or BCG-Naïve
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.
The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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Evaluating The Addition Of The Immunotherapy Drug Atezolizumab To Standard Chemotherapy Treatment For Advanced Or Metastatic Neuroendocrine Carcinomas That Originate Outside The Lung
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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A Study of the Safety and Effectiveness of Nivolumab for the Treatment of Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to determine whether nivolumab alone or in combination with standard of care therapies will provide clinical benefit without unacceptable toxicity for the treatment of advanced non-small cell lung cancer patients.
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A Study Using A New Drug, Nivolumab, In Combination With Chemotherapy Drugs To Treat A Type Of Cancer Called Nasopharyngeal Carcinoma (NPC)
Rochester, MN
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. 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 gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer ...
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Futibatinib And Pembrolizumab For The Treatment Of Advanced Or Metastatic FGF19 Positive BCLC Stage A, B, Or C Liver Cancer
Rochester, MN
This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...
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Bemarituzumab Plus Chemotherapy And Nivolumab Versus Chemotherapy And Nivolumab Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.
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A Study to Analyze The Impact of Pharmacist Consultation in Patients Beginning Intravenous Cancer Treatment
La Crosse, WI
The purpose of this study is to assess the impact of pharmacist consultation in patients receiving first dose, first cycle intravenous cancer treatment on patient understanding of the cancer treatment, adverse drug events, and adherence. Additionally, this study will report the frequency of healthcare utilization for side effect management.
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A Phase 2 Study Of Atezolizumab (An Engineered Anti-PDL1 Antibody) As Monotherapy Or In Combination With Avastin (Bevacizumab) Compared To Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma [IMmotion150]
Jacksonville, FL
This multicenter, randomized, open-label study will evaluate the efficacy and safety of atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and ...
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Atezolizumab Immunotherapy In Patients With Advanced NSCLC (AJCC 7th Edition)
Scottsdale/Phoenix, AZ
Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC (AJCC 7th Edition) eligible for chemoradiotherapy with curative intent.
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Effectiveness And Safety Of Pembrolizumab For Participants With Resectable Stage IIB Or IIIA Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
This trial will evaluate the safety and effectiveness of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).
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A Study To Evaluate The Effect Of Canakinumab Or Pembrolizumab Given As Monotherapy Or In Combination As Neo-adjuvant Treatment For Subjects With Early Stages NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of canakinumab or pembrolizumab as monotherapy or combined as neo-adjuvant treatment for subjects with early stage non-small cell lung cancer.
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A Study To Evaluate The Immune Response To Anti-HER2 Therapies
Jacksonville, FL
The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.
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A Study Of Subcutaneous Nivolumab + Relatlimab FDC In Previously Untreated Metastatic Or Unresectable Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.
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Lung Nodule Management And Lung Cancer Screening In Patients With Abnormal Ct-Scan
Jacksonville, FL
The purpose of this study is to assess the current rate of adherence to incidental lung nodule management and lung cancer screening guidelines in at-risk lung cancer patients identified from chart review.
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A Study To 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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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; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
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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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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Nivolumab After Combined Modality Therapy In Treating Patients With High Risk Stage II-IIIB Anal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
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A Study Of Atezolizumab Alone Or Combined With Immunomodulatory Drug And/or Daratumumab In Multiple Myeloma Patients
Scottsdale/Phoenix, AZ; 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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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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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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Study Of DS-8201a In Subjects With Advanced Solid Malignant Tumors
Jacksonville, FL
This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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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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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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Sacituzumab Tirumotecan (MK-2870) In Combination With Pembrolizumab Versus Pembrolizumab Alone In Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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Testing The Addition Of MEDI4736 (Durvalumab) To Chemotherapy Before Surgery For Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL; Rochester, MN
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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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 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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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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Study Of Pembrolizumab (MK-3475) As Monotherapy In Participants With Previously-Treated Locally Advanced Unresectable Or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
Rochester, MN
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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A Study To Evaluate The Safety And Efficacy Of Two Dose Levels Of ONO-4578 With Opdivo®, In Combination With MFOLFOX6 And Bevacizumab Versus Standard Of Care In Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
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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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Letrozole After Tamoxifen in Treating Women With Breast Cancer
La Crosse, WI
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
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A Study Of Alisertib In Combination With Endocrine Therapy In Patients With HR-positive, HER2-negative Recurrent Or Metastatic Breast Cancer (ALISCA-Breast1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; 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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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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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Ipilimumab With Or Without Talimogene Laherparepvec In Unresected Melanoma
Jacksonville, FL
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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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Study To Evaluate The Safety And Effectiveness Of Pembrolizumab Compared To Placebo In Resected High-risk Stage II Melanoma Patients
Jacksonville, FL; Rochester, MN
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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Screening For High Frequency Malignant Disease
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.
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A Study to Evaluate the Effects of Exercise on Fatigue in Thyroid Cancer Survivors
Rochester, MN
The purpose of this study is to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients, and to determine the effect of a home-based program compared to a center- based program.
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Cytotoxic Activity of Lenalidomide in Combination with the Bispecific CD30/CD16a Therapeutic Monoclonal Antibody, AFM13
Jacksonville, FL
The purpose of this study is to determine whether lenalidomide enhances the activation potential of NK cells derived from Hodgkin’s lymphoma patients. The study also aims to determine if lenalidomide treated NK cells are more efficient in killing CD30+ tumor cells (cancer cell lines) in combination with an investigational agent (AFM13, CD30/CD16a mAb, Affimed Therapeutics, Germany), which engages both the CD30+ tumor cell and CD16a+ NK cells.
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Nivolumab In Treating Patients With Relapsed Or Refractory Peripheral T-cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
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Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer
Rochester, MN
This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
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A Study of Combination Chemotherapy for Treating Women with Stage II or Stage IIIA Breast Cancer that has Spread to the Lymph Nodes
Eau Claire, WI
The purpose of this study is to compare the effectiveness of two different combinations of chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice And Pembrolizumab In Patients With Previously Untreated, Locally Advanced Inoperable Or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
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Study Of PSMA-targeted Therapy And Androgen Receptor Suppression In Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
Rochester, MN
The purpose of this study is to Evaluate whether 177Lu-PSMA-617 + (iADT) ± (iAA+P) can lower 18-month radiographic progression-rates compared (iADT) ± (iAA+P)in patients with low-volume metastatic hormone-sensitive prostate cancer (mHSPC).
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Ipilimumab And Nivolumab As Adjuvant Treatment Of Mucosal Melanoma
Rochester, MN
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.
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Expanded Access Program With Nivolumab (BMS-936558) In Combination With Ipilimumab (Yervoy®) In Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable Or Metastatic Melanoma (CheckMate 218)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.
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Melanoma Relatlimab Nivolumab
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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A Study To Evaluate Larotrectinib To Treat Patients With Previously Untreated TRK Fusion Solid Tumors And TRK Fusion Relapsed Acute Leukemia
Rochester, MN
The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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Study Comparing Tarlatamab And Durvalumab Versus Durvalumab Alone In First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide And Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Pembrolizumab And Lenvatinib In Clear Cell Ovarian Cancer
Rochester, MN
The purpose of this trial is to investigate the clinical effectiveness of the combination of pembrolizumab and lenvatinib in patients with recurrent or persistent clear cell carcinoma of the ovary (CCOC) as measured by the multiple primary endpoints of objective response rate (ORR) and rate of PFS at 6 months (PFS6) per RECIST 1.1.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Study Of Pembrolizumab (MK-3475) Combination Therapies In Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Locally Advanced Or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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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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A Study Of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared To Pembrolizumab Alone In People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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Genetic Analysis In Blood And Tumor Samples From Patients With Advanced Or Metastatic Estrogen Receptor Positive And HER2 Negative Breast Cancer Receiving Palbociclib And Endocrine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Adaptive Therapy With Capecitabine For Treatment Of Metastatic ER Positive, HER2 Negative Breast Cancer
Scottsdale/Phoenix, AZ
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 ...
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Study Of SAR444881 Administered Alone And In Combination With Other Therapeutics In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with ...
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177Lu-DTPA-Omburtamab Radioimmunotherapy ToTreat Recurrent Or Refractory Medulloblastoma
Rochester, MN
The purpose of this study is to assess 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3, to treat children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy.
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A Study Of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) In Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel In Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
Scottsdale/Phoenix, AZ
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).
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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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Methotrexate, Erlotinib, And Celecoxib For The Treatment Of Recurrent/Metastatic Oral Cavity Cancer In A Rural Midwest United States Population
Albert Lea, MN; La Crosse, WI; Rochester, MN
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by ...
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A Study To Evaluate 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
Albert Lea, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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A 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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ACP-196 In Combination With Pembrolizumab, For Treatment Of Hematologic Malignancies
Jacksonville, FL; Rochester, MN
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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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 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
Albert Lea, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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A 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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ACP-196 In Combination With Pembrolizumab, For Treatment Of Hematologic Malignancies
Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety profile of acalabrutinib and pembrolizumab in subjects with hematologic malignancies.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Mankato, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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A 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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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.
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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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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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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 Explore the Effects of the Measles Virus on Tumor Immunity
Rochester, MN
The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.
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A Study To Evaluate The Safety, Tolerability, And Determine The Optimal Dose For The Expansion Cohorts Of VSV-IFNβ-NIS In Combination With Pembrolizumab In Patients With Refractory Solid Tumors
Rochester, MN
The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).
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A Study Of Neoadjuvant/Adjuvant Durvalumab For The Treatment Of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
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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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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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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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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 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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A Study Testing The Effect Of Immunotherapy (Ipilimumab And Nivolumab) In Patients With Recurrent Glioblastoma With Elevated Mutational Burden
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
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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A Study To Assess The Safety And Tolerability Of Atezolizumab In Combination With Other Immune-Modulating Therapies In Participants With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...
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Study To Evaluate Mechanisms Of Immunomodulator Sensitivity And Resistance In Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine response rates (>=PR) of prospectively treated MM patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
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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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Measuring If Immunotherapy Plus Chemotherapy Is Better Than Chemotherapy Alone For Patients With Aggressive Poorly Differentiated Sarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.
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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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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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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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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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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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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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Tamoxifen Citrate, Letrozole, Anastrozole, Or Exemestane With Or Without Chemotherapy In Treating Patients With Invasive RxPONDER Breast Cancer
Mankato, MN
This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.
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A Study Of Nivolumab In Participants With Metastatic Or Unresectable Bladder Cancer
Scottsdale/Phoenix, AZ
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 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Rochester, MN
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
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Evaluation Of Outcomes In Metastatic Gastric And Esophageal Carcinoma In Relation To Immunotherapy
Rochester, MN
The purpose of this study is:
To assess the efficacy of treatment with checkpoint inhibitors (Pembrolizumab or Nivolumab) in metastatic gastric and esophageal carcinoma through retrospective chart review.
To explore if response to checkpoint inhibitors is dependent on biomarkers on tumor tissue.
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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 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 To Examine The Effects Of Novel Therapy Linvoseltamab In Combination With Other Cancer Treatments For Adult Participants With Multiple Myeloma That Is Resistant To Current Standard Of Care Treatments
Rochester, MN
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).
This study is the first time linvoseltamab will be combined with other cancer therapies.
The main goal is to understand if linvoseltamab can be given safely ...
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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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A Clinical Study Of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) In People With Breast Cancer (MK-2870-032)
Scottsdale/Phoenix, AZ; Jacksonville, FL
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab ...
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A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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Induction Pembrolizumab And Chemotherapy Followed By Pembrolizumab Before Chemoradiation And Pembrolizumab Maintenance Compared To Standard Chemoradiation With Pembrolizumab Followed By Pembrolizumab Maintenance In High-Risk Cervical Cancer
Rochester, MN
This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer ...
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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 Immunotherapy For Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy In HER2-positive Breast Cancer Patients
Rochester, MN
The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.
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A Study To Evaluate Chemotherapy-Induced Nausea In Breast Cancer Patients
Albert Lea, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Mankato, MN; Rochester, MN
The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.
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Niraparib + TSR042 In BRCA Mutated Breast Cancer
Rochester, MN
The purpose of this study is to evaluate pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA mutations. The drugs are Niraparib (Zejula) and Dostarlimab.
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The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Jacksonville, FL; Rochester, MN
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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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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Randomized, Open Label, Clinical Study Of The Targeted Therapy, Palbociclib, To Treat Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
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A Study to Analyze CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
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A Study to Analyze CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
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A Study 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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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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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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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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A Clinical Study Of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) In People With Breast Cancer (MK-2870-032)
Scottsdale/Phoenix, AZ; Jacksonville, FL
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab ...
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Induction Pembrolizumab And Chemotherapy Followed By Pembrolizumab Before Chemoradiation And Pembrolizumab Maintenance Compared To Standard Chemoradiation With Pembrolizumab Followed By Pembrolizumab Maintenance In High-Risk Cervical Cancer
Rochester, MN
This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer ...
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A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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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 Of Three-dimensional (3-D) Tissue Models In Patients With Serous Endometrial Cancer Planning To Undergo Surgery
Jacksonville, FL; 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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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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A Study Of An FGFR2/3 Inhibitor (CGT4859) In Patients With Cholangiocarcinoma And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
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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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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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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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An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation In PSMA Positive OMPC.
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
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Assessing Breast Cancer Risk Perception In Hispanic, Black, And Black Hispanic Women
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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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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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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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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First In Human Study Of TORL-1-23 In Participants With Advanced Cancer
Rochester, MN
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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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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Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
Rochester, MN
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 mCi Tc-99m sestamibi.
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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; Jacksonville, FL; Rochester, MN
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 To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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 To Learn About The Study Medicine (Elranatamab) In Participants With Multiple Myeloma That Has Come Back After Responding To Treatment Or Has Not Responded To Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every ...
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Investigation Of Ubamatamab Combination Therapy In Adult Participants With Platinum-Resistant Ovarian Cancer
Jacksonville, FL
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug ...
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Hypofractionated Radiotherapy With Folfox For Esophageal/Gej Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate non-inferiority of pCR with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
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Ibrutinib In Treating Patients With Relapsed Hairy Cell Leukemia
Rochester, MN
This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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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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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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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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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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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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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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TheraSphere With And Without Durvalumab And Tremelimumab For HCC
Jacksonville, FL
The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.
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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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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 CG0070 Given In Combination With Pembrolizumab, In Non Muscle Invasive Bladder Cancer, Unresponsive To Bacillus Calmette-Guerin
Rochester, MN
The primary purpose of this study is to evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
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A Study to Evaluate MRI-guided Cryoablation for Focal Native Intermediate Grade Prostate Cancer
Rochester, MN
The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data. The system is already FDA (510k) approved for soft tissue ablation and has been utilized successfully at Mayo previously.
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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
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. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
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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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Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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A Study To Evaluate 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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Durvalumab And Grid Therapy For The Treatment Of Non-small Cell Lung Cancer In Patients Who Progressed During Or After Treatment With The PACIFIC Regimen
Rochester, MN
The purpose of this study is to determine whether combining grid therapy at the time of disease progression during durvalumab administration or shortly after durvalumab discontinuation may permit patients to continue on durvalumab which was otherwise effective at preventing polymetastatic disease.
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Safety And Efficacy Of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells In Subjects With Relapsed Or Refractory BAFFR-expressing B-cell Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of escalating doses of MC10029 following lymphodepleting (LD) therapy in subjects with relapsed or refractory BAFFR-expressing B-cell hematologic malignancies to determine the recommended dose for phase 1b (dose expansion).
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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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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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5-strain Probiotic Formulation In Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor To Prevent Bone Loss
Jacksonville, FL
The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF-038 in early-stage breast cancer patients receiving aromatase inhibitors after 3- and 12-month treatment.
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Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
Rochester, MN
This partially randomized phase III trial studies isotretinoin with monoclonal antibody Ch14.18, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to ...
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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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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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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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Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Rochester, MN
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. ...
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A Comparison Of TULSA Procedure Vs. Radical Prostatectomy In Participants With Localized Prostate Cancer (CAPTAIN)
Jacksonville, FL; Rochester, MN
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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Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
Jacksonville, FL
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
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A Study To Compare Linvoseltamab And Daratumumab Treatment In High-Risk Smoldering Multiple Myeloma (HR-SMM)
Scottsdale/Phoenix, AZ; Rochester, MN
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.
The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make ...
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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 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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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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Kinetics Of Troponin And BNP In Breast Cancer Chemotherapy With Adriamycin And Trastuzumab
Jacksonville, FL
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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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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Acceptance And Commitment Therapy For Cancer Distress Among Rural And Urban Patients With Hepatobiliary Cancers
Rochester, MN
The purpose of this study is to assess standardized benchmarks of intervention feasibility and acceptability for remotely delivered, group ACT-HBC, as tested with a single-arm pilot study. Determine if there are changes in psychological variables from baseline to completion of the ACT-HBC intervention. To explore the preliminary impact of rural status on feasibility and acceptability of the intervention in addition to outcomes of distress and theory-based statistical mediators/psychological mechanisms of ACT-HBC.
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Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Mankato, MN
RATIONALE: Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
PURPOSE: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.
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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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Improving Treatment Planning Suing LiDAR Surface Mapping Of Radiotherapy Patients
Jacksonville, FL
The purpose of this study is to show the feasibility of using the LiDAR scanner to supplement the radiation treatment simulation CT scan.
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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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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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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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Proton Therapy For Partial Breast Irradiation In Early Stage Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) In Patients With Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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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 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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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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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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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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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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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 Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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A Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Rochester, MN
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
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A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
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A Study To Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients For T-cell Directed Immunotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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A Study Comparing Ibrutinib And Obinutuzumab With Or Without Venetoclax In Treating Patients With Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; 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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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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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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HEADLIGHT: Hypofractionated Proton Therapy For Head And Neck Cancers
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, 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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Study Of Daraxonrasib And Daraxonrasib + GnP As First-line Treatment In Patients With Metastatic Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
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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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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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A Study Of Ovarian Tissue Freezing For The Preservation Of Fertility In Children
Rochester, MN
The purpose of this study is to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Since this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.
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A Study To Evaluate Brentuximab Vedotin Or Placebo In Combination With Lenalidomide And Rituximab In Subjects With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...
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A Study 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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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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AB-2100, An Integrated Circuit T (ICT) Cell Therapy In Patients With Recurrent Clear-cell Renal Cell Carcinoma (CcRCC)
Scottsdale/Phoenix, AZ
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
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An Open-label Study To Assess The Anti-Tumor Activity And Safety Of REGN1979, An Anti-CD20 X Anti-CD3 Bispecific Antibody, In Patients With Relapsed Or Refractory B-cell Non-Hodgkin Lymphoma
Rochester, MN
The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979 as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) non-Hodgkin lymphoma (B-NHL) subgroups.
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LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Rochester, MN
The purpose of this study is to investigate the safety, effectiveness, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.
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NKX101, Intravenous Allogeneic CAR NK Cells, In Adults With AML Or MDS
Jacksonville, FL
The primary purpose of this study is to assess the safety and tolerability of NKX101 including dose-limiting toxicities (DLTs), and to identify the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of NKX101.
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Epcoritamab Compared To Observation For Treating B-cell Lymphoma Patients Not In Complete Remission After CD19-directed CAR-T Therapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.
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A Study To Optimize Endocrine Therapy Through Motivational Interviewing And Text Interventions
Albert Lea, MN; Rochester, 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 To Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) For Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, And Daratumumab In Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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A Study Of Belantamab Mafodotin (GSK2857916) In Multiple Myeloma Participants With Normal And Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Patient Survey of Molecular Breast Imaging
Rochester, MN
The purpose of this study is to gather qualitative information about patient comfort during MBI examinations. The primary aim is to assess patient comfort during MBI, relative to comfort during a mammogram. We also wish to identify factors that contribute to discomfort and patients’ willingness to have MBI in the future.
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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Study Of Endocrine Therapy With Or Without Abemaciclib (LY2835219) Following Surgery In Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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Impact Of Aromatase Inhibitor Therapy On Glucose Homeostasis And Diabetes Risk
Rochester, MN
This study assesses the effect of hormone directed treatment for breast cancer or ductal carcinoma in situ (DCIS) on glucose metabolism.
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AZD0120 In Relapsed/Refractory Multiple Myeloma (DURGA-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.
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A Study To Evaluate Nutrition Therapy In Improving Immune System In Bladder Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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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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Cabozantinib-S-Malate In Treating Younger Patients With Recurrent, Refractory, Or Newly Diagnosed Sarcomas, Wilms Tumor, Or Other Rare Tumors
Rochester, MN
This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
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ZTE MRI For Visualization Of Bone Cement, Breast Biopsy Markers
Rochester, MN
The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
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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; Jacksonville, FL; 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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Fertility Outcomes in Lymphoma Patients
Jacksonville, FL
The objectives of this study are to analyze impact of radiation on fertility, to correlate the clinical outcome of fertility after chemotherapy and or radiation, and to evaluate the different modalities and cost/benefit of fertility preservation in lymphoma patients
Lymphoma is a diversified disease with outcomes differing upon the types and subtypes of lymphoma as well as treatment modalities used. Fertility outcomes in patients treated with chemotherapy and/or radiation could vary and largely unknown.
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A Study Of 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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A Trial Of RAdium-223 And SABR Versus SABR For OligomEtastatic Prostate CaNcerS (RAVENS)
Rochester, MN
The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.
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Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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A Study To Explore Quality Of Life According To Treatment Plan For Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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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 To Evaluate The Clinical Outcome Of Chimeric Antigen Receptor T-cell Therapy
Rochester, MN
CAR-T therapy is a new therapy that is a promising strategy to treat certain types of cancer. FDA has approved 5 CAR-T therapy to treat pediatric and young adult with B-cell acute lymphoblastic leukemia (B-ALL) and adults with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). There are more clinical trials underway to test this treatment modality in different setting in these cancers and to test CAR-T in other types of cancer. As we transition CART into real-world clinical practice, it is important to see if the clinical outcome such as clinical response and side effects reported in clinical trials are the ...
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A Study Of Vaccine Therapy In Treating Patients With Malignant Peripheral Nerve Sheath Tumors That Are Recurrent Or Cannot Be Removed By Surgery
Rochester, MN
The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).
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Ultrasound-Guided Core Needle Biopsy To Stage Urothelial Carcinoma Of The Bladder (US UCB)
Rochester, MN
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
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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 Evaluate The Safety And Efficacy Of Mesothelin-Targeting Logic-gated CAR T, In Participants With Solid Tumors That Express MSLN And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment ...
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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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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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Lenalidomide And Dexamethasone With Or Without Bortezomib In Treating Patients With Previously Untreated Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...
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Photoradiation With Verteporfin To Facilitate Immunologic Activity Of Pembrolizumab In Unresectable, Locally Advance Or Metastatic Pancreatic Cancer
Rochester, MN
We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.
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A Study to 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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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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Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, And Cyclophosphamide In Treating Patients With Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Empty Bladder Impact During Radiation Therapy For Prostate Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether an empty bladder during radiation therapy delivery for prostate cancer affects patient-reported urinary symptoms related to treatment.
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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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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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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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The Captivator EMR Registry
Jacksonville, FL; Rochester, MN
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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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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Safety And Efficacy Study Of TX103 CAR-T Cell Therapy For Recurrent Or Progressive Grade 4 Glioma.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
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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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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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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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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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A Study To Test The Addition Of Berzosertib To Usual Radiation Treatment For Chemotherapy-Resistant Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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De-Escalation Of Breast Radiation Trial For Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than Or Equal To 18 Breast Cancer (DEBRA)
Albert Lea, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
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GENetic Risk Estimation Of Breast Cancer Prior To Decisions On Preventive Therapy Uptake, Risk Reducing Surgery Or Intensive Imaging Surveillance
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; 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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Colorectal Cancer Screening In Black And Underserved Communities In The Phoenix Metro Area
Scottsdale/Phoenix, AZ
The aims of this study are to increase the number of Black consultants at MCA, make a meaningful impact on interactions among staff, leadership, and patients, and increase the number of Black staff in leadership roles beyond Diversity and Inclusion efforts.
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Water Vapor Ablation For Localized Intermediate Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.
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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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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection For Patients With Early-Stage Oral Cavity Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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Atezolizumab In Combination With A Multi-Kinase Inhibitor For The Treatment Of Unresectable, Locally Advanced, Or Metastatic Liver Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to test whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). 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. ...
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Trial Using Keytruda As Initial Therapy In The Treatment Of Advanced Mycosis Fungoides
Jacksonville, FL
The purpose of this trial is to evaluate the antitumor activity of Pembrolizumab in patients with advanced mycosis fungoides (MF) as initial systemic therapy.
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Retifanlimab And Epacadostat In Combination With Radiation And Bevacizumab In Patients With Recurrent Gliomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.
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A Study Of Tucatinib Or Placebo With Trastuzumab And Pertuzumab For Metastatic HER2+ Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. 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 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 ...
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A Study Of Adjuvant Cretostimogene Grenadenorepvec For Treatment Of Intermediate Risk NMIBC Following TURBT
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
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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
Scottsdale/Phoenix, AZ; 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 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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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
Albert Lea, MN; Austin, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to analyze the prevalence of mood disorders in newly-diagnosed breast cancer patients with use of specific questionnaires, aimed to diagnose clinically significant depression and anxiety, at a rural community hospital.
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A Study To Collect And Correlate The Data From Multiple Risk Assessments For Heart Toxicity In Patients Receiving Chemotherapy For Breast Cancer
Rochester, MN
The purpose of this study is to collect and correlate the data from various cardiovascular risk asessments to successfully measure the risk of heart toxicity in patients receiving chemotherapy for breast cancer.
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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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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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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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Study Comparing CB-839 With Cabozantinib Vs. Cabozantinib With Placebo In Patients With Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.
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Measuring Cell Free DNA During The Course Of Treatment For Esophageal Cancer As A Marker Of Response And Recurrence
Rochester, MN
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging And Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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De-Escalated Adjuvant And Definitive Radiation Therapy Informed By DART 2.0 CtHPV-DNA
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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survey with parents of children who had proton treatment for brain tumors
Rochester, MN
The overall goal of this project is to survey parents of children who have undergone proton radiation for brain tumors and collect key information that will improve the feasibility of our proposed intervention. The survey will include questions on experience with proton treatment and opinion regarding a proposed early intervention.
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A Study Of Prehabilitation In Patients With Multiple Myeloma Receiving CAR-T Therapy
Rochester, MN
The purpose of this study is to evaluate the feasibility and acceptability of a 6-week home-based virtual prehabilitation program with remote monitoring in 20 patients ≥60 years with relapsed/refractory (R/R) multiple myeloma (MM) scheduled to receive CAR-T therapy at Mayo Clinic – Rochester.
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A Study to Optimize Patient Selection and Outcomes in Laryngeal Vascular Composite Allograft Transplantation
Scottsdale/Phoenix, AZ
In-depth qualitative interviews will be performed to explore beliefs of laryngotracheal transplant candidates, their caregivers, and clinicians about their perceptions and experience of the laryngotracheal transplantation process. In addition, we will explore the quality of life of patients with a laryngectomy.
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Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Rochester, MN
Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.
Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.
GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity ...
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Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease For HPV(-) Head And Neck Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with HPV(-) head and neck cancer.
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Tumor Treating Fields For The Treatment Of Leptomeningeal Metastases Of The Spine In Patients With Breast Or Lung Cancer
Jacksonville, FL
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
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A Study To Assess The Efficacy, Safety, Pharmacodynamics, And Pharmacokinetics Of Tazemetostat In Combination With Lenalidomide Plus Rituximab Versus Placebo In Combination With Lenalidomide Plus Rituximab In Adult Patients At Least 18 Years Of Age With Relapsed/Refractory Follicular Lymphoma.
Jacksonville, FL; Rochester, MN
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.
Stage 1 of this trial studied the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.
Stages 2 and 3 were ...
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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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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 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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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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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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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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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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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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Extracellular Impact Of Ultrasound-induced Blood-brain Barrier Disruption
Rochester, MN
The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.
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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 Of Quality Of Life After Thyroid Cancer Surgery
Scottsdale/Phoenix, AZ
The purpose of this study is to create a prospectively maintained database of patient and clinical factors, as well as collect survey data using validated quality-of-life metrics, to determine the impact and factors associated with quality of life after thyroid surgery for thyroid cancer.
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Safety And Activity Of PolyPEPI1018 Plus Atezolizumab In Colorectal Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Rochester, MN
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
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A 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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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 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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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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Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP In Newly Diagnosed High-intermediate And High Risk DLBCL Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.
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Targeted Therapy Directed By Genetic Testing In Treating Patients With Locally Advanced Or Advanced Solid Tumors, The ComboMATCH Registration Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P
atients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) ...
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations
Rochester, MN
This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...
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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Mankato, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
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REFINE: Regorafenib Observational Study In Hepatocellular Carcinoma
Rochester, MN
The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.
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A Study Evaluating The Efficacy Of Venetoclax Plus Ibrutinib In Subjects With T-cell Prolymphocytic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:
Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.
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DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.
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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
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A Study of 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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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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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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Combining Immunotherapy And Radiation Therapy To Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a ...
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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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A Study Of Bladder Filling Variations During Radiation Therapy In Patients Undergoing Radiation Treatment For Prostate Cancer
Jacksonville, FL
The purpose of this study is to examine bladder filling for radiation treatment to the prostate, and to evaluate how bladder fullness changes daily during radiation treatment.
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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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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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Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors
Albert Lea, MN; Mankato, MN; Rochester, MN
This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and ...
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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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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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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 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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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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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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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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A Study To Compare Administering Olaparib Concurrently With Radiotherapy Vs. Radiotherapy Alone In Treating Patients With Inflammatory Breast Cancer
Eau Claire, WI; La Crosse, 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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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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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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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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Eliminating Breast Cancer Surgery In Exceptional Responders With Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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Congenital Heart Disease Skin Punch Biopsy Sample Collection
Rochester, MN
The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use, and Reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
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A Study to Collect Ovarian Tissue from Girls Undergoing Fertility-preserving Cryopreservation
Rochester, MN
The purpose of this study is to study the handling of ovarian tissue, cryopreservation technology, and oocyte maturation for female pediatric cancer patients and other female patients whose future fertility will be affected due to a disease or treatment.
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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MelmarT Melanoma Margins Trial Investigating 1cm V 2cm Wide Excision Margins For Primary Cutaneous Melanoma (MelMarT)
Scottsdale/Phoenix, AZ; Jacksonville, FL
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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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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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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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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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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Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate The Reservoir]
La Crosse, WI; Rochester, MN
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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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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A Study To Evaluate The Safety, Effectiveness And Tolerable Dose Of Arlocabtagene Autoleucel (BMS-986393) In Novel Combinations In Participants With Relapsed And/or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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A Study Of Cannabis Withdrawal In Hospitalized Patients With Hematological Malignancies Undergoing Bone Marrow Transplant (BMT) Or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the prevalence of cannabis withdrawal and to characterize the clinical manifestations of cannabis withdrawal syndrome in patients hospitalized for BMT or CAR-T therapy.
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Pituitary tumor registry
Rochester, MN
The purpose of this data registry involves the collection of standard of care clinical treatment regimens, diagnostic information and surgical outcomes which may include human specimens and associated genomewide expression data.
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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A Study Of Lutetium Lu 177 Dotatate (Lutathera®) In Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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Study Of RYZ401 In Subjects With Solid Tumors Expressing SSTRs.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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A 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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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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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
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 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 Of Intratumoral Injection Of Autologous Dendritic Cells After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Liver Cancer
Rochester, MN
The primary purpose of the pilot 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).
The primary purpose of the phase II 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 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 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 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 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
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, 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 Emory and ...
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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 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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Robotic-Assisted Da Vinci System Prophylactic Nipple-Sparing Mastectomy
Jacksonville, FL; Rochester, MN
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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A Study To 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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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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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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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 Of The Effectiveness And Safety Of CTL019 In Adult Patients With Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy and safety of CTL019 in adult patients with relapsed or resistant diffuse large B-cell lymphoma.
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A Study 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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Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
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Testing The Role Of DNA Released From Tumor Cells Into The Blood In Guiding The Use Of Immunotherapy After Surgical Removal Of The Bladder, Kidney, Ureter, And Urethra For Urothelial Cancer Treatment, MODERN Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are ...
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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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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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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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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; Jacksonville, FL; Rochester, MN
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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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 for Cerebral Open Flow Microperfusion
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
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A Study Of Clonal Hematopoiesis (CH) And Hematological Toxicity After Cancer Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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A 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 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 Evaluate Yttrium-90 Therapy For Radiation Lobectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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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First In Human (FIH) Study Of REGN5459 In Patients With Relapsed Or Refractory Multiple Myeloma (MM)
Rochester, MN
The purpose of this study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
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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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Study Of [68Ga]FAPI-46 PET In Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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Selection Of Allogeneic Hematopoietic Cell Donors Based On KIR And HLA Genotypes
Rochester, MN
The purpose of this study is to test whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will ...
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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 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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A Study To Evaluate Daratumumab/rHuPh20 +/- Lenalidomide As Post-ASCT Maintenance For Multiple Myeloma With Minimal Residual Disease (MRD) To Direct Therapy Duration
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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Conventionally Fractionated Vs. Hypofractionated
Comprehensive Nodal Irradiation For Breast Cancer Using Pencil Beam Scanning ProtonTherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the 2-year rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated pencil beam scanning proton therapy (PBS-PT) is non-inferior to conventionally-fractionated PBS-PT.
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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 3D-Printed External Breast Prosthesis For The Improvement Of Patient-reported Outcomes Among Breast Cancer Patients That Underwent A Mastectomy Without Reconstruction
Rochester, MN
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is ...
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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 3D-Printed External Breast Prosthesis For The Improvement Of Patient-reported Outcomes Among Breast Cancer Patients That Underwent A Mastectomy Without Reconstruction
Rochester, MN
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is ...
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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 to enroll in a randomized trial ...
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A Study Comparing Abemaciclib Plus Temozolomide To Temozolomide Monotherapy In Children And Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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A Study Of Nivolumab And Multi-fraction Stereotactic Radiosurgery With Or Without Ipilimumab In Treating Participants With Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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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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MC230818 Understanding The Mechanisms Of Clonal And Non-clonal Cytopenia Following CAR-T Therapy
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene ...
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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 Develop And Validate Hybrid Molecular Imaging To Transform The Care Of Hepatocellular Carcinoma Patients
Rochester, MN
The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.
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A Study Comparing Sublobar Resection Versus Stereotactic Ablative Radiotherapy For Lung Cancer
Rochester, MN
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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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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Defining The Immunologic Profile Of Sentinel Lymph Nodes And Identifying The Mechanisms Responsible For Immunosuppression
Jacksonville, FL; Rochester, MN
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 To Evaluate Chemoradiotherapy With Or Without Atezolizumab In Treating Patients With Localized Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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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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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 Multi-Center Study Evaluating KTE-X19 In Pediatric And Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.
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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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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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Spearhead 1 Study In Subjects With Advanced Synovial Sarcoma Or Myxoid/Round Cell Liposarcoma
Jacksonville, FL
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
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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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Scottsdale/Phoenix, AZ; Rochester, MN
This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference ...
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FT819 In Subjects With B-cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and clinical activity of FT819 in r/r B-cell malignancies, including the effect of a step-fractionated dosing schedule on mitigating safety risks and improving tolerability.
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A Study To Compare The Effectiveness And Safety Of Bb2121 Versus Standard Regimens In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).
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A Study To Evaluate The Safety And Effectiveness Of Idecabtagene Vicleucel To Treat Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information.
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Long-Term Follow-up Protocol For Participants Treated With Gene-Modified T Cells
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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Heated Intraperitoneal Chemotherapy Followed By Niraparib For Ovarian, Primary Peritoneal And Fallopian Tube Cancer (HOTT)
Rochester, MN
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...
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A Study Of JNJ-68284528, A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) In Participants With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
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Manufacturing Outcomes With Patient Factors From Multiple Myeloma Patients Prescribed Ciltacabtagene Autoleucel
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify patient factors that are associated with low-viability or low-dose out-of specification (OOS) in ciltacabtagene autoleucel drug product (DP).
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
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GPRC5D-directed CAR T Cell Therapy In Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.
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Testing Whether Treating Breast Cancer Metastases With Surgery Or High-Dose Radiation Improves Survival
Jacksonville, FL; Rochester, MN
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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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 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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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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Melodi Matrix™ In Breast Reconstruction
Rochester, MN
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
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A Study to Evaluate Surgical Outcomes and Quality of Life after Breast Reconstruction
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the surgical outcomes that patients have after breast reconstruction, and to assess how reconstruction has affected their quality of life.
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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 Of Nipple Reconstruction Following Post-Mastectomy Breast Reconstruction
Jacksonville, FL
The purpose of this study is to determine what patient or clinical factors are predictive for the choice to have nipple reconstruction or type of nipple reconstruction.
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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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Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the ...
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A Study to 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 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 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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Short Course Radiotherapy For The Treatment Of Patients With Glioblastoma, SAGA Study
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 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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Cerebrospinal Fluid Biomarkers For Brain Tumors
Rochester, MN
The purpose of this study is to help generate a repository of Cerebrospinal Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.
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Ommaya At Biopsy
Rochester, MN
The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.
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Testing Whether High Dose Chemotherapy And Infusion Of The Patients' Own Stem Cells Improves Survival In Patients With Peripheral T-cell Lymphoma Who Achieved A Complete Response At The End Of The Initial Chemotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior ...
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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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A Study Comparing Proton And Photon Radiation Outcomes In Prostate Cancer Patients
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
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 Compare Proton Therapy To Photon Radiation Therapy For Esophageal Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Mankato, MN; 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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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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Rituximab With Or Without Stem Cell Transplant In Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma In First Complete Remission
Jacksonville, FL; Rochester, MN
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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Feasibility Of Intraoperative Microdialysis During Neurosurgery For Central Nervous System Malignancies
Rochester, MN
This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.
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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 Evaluate The Role Of Gut Microbiome In Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.
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Pre-operative Vs. Post-operative Radiosurgery For Metastatic Brain Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
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The NeoGlioma Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.
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A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.
Scottsdale/Phoenix, AZ
This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.
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Comparison Of Acute Toxicities Between Patients Treated With Protons Or Intensity Modulated Radiation Therapy After Surgery For The Treatment Of Endometrial Or Cervical Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).
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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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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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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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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, common iliac, obturator packet, ...
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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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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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SPORT-DMG
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.
Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study
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A Study to 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 to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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Automated Breast Measurements
Jacksonville, FL
The correction of breast asymmetries requires the capture of accurate surface images and anatomical measurements of the breast. Currently, surface breast measurements are performed manually. We hypothesize that using the true depth imaging sensors embedded within mobile devices and differential algorithms, breast measurements can be performed in an automated format. These measurments can be potentially utilized for the production of asymmetric garments to improve comfort and symmetry.
The study plans to include female subjects (ages 18 – 85) previously evaluated for aesthetic and reconstructive breast surgery and add new subjects who desire aesthetic or reconstructive breast surgery ...
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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; Eau Claire, WI; La Crosse, WI; Mankato, MN; 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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Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Rochester, MN
The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.
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A Study to Evaluate Support Services for Managing Urological Conditions
Scottsdale/Phoenix, AZ
The purpose of this study is to assess if men and women seeking care for urological diseases have interest in support services in conjunction with standard of care.