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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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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 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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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 Find New Family Linked Forms Of Kidney Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to use the saliva of patients and relatives with known kidney cancer to look for unknown genes that may cause kidney cancer and are being passed down between family members
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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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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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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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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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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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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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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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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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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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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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Surgical Drain Fluid For Detection Of Molecular Residual Disease (MRD) In Bladder, Renal And Urothelial Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with bladder, renal or urothelial cancer.
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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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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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APL-101 Study Of Subjects With NSCLC With C-Met EXON 14 Skip Mutations And C-Met Dysregulation Advanced Solid Tumors (SPARTA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 1 / 2 open-label study to assess the safety and tolerability of APL-101, to determine the RP2D and dose limiting toxicities for APL-101, and to obtain preliminary efficacy in subjects
with c-Met dysregulation in advanced malignancies and Non-Small Cell Lung Cancer (NSCLC). c-Met dysregulation will be determined by local/archival molecular pre-screening evaluations for eligibility of enrollment.
Mayo Clinic will be participating in both Part A (Phase 1) & (Phase 2) B of the study.
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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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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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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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A Study To Evaluate The Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy ...
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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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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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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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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.