Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Recruiting Phase 2 Interventional Study
Bladder Adenocarcinoma Bladder Clear Cell Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Neuroendocrine Carcinoma Bladder Small Cell Neuroendocrine Carcinoma Bladder Squamous Cell Carcinoma Chromophobe Renal Cell Carcinoma Collecting Duct Carcinoma Invasive Bladder Giant Cell Urothelial Carcinoma Invasive Bladder Lymphoepithelioma-Like Carcinoma Invasive Bladder Nested Urothelial Carcinoma Invasive Bladder Plasmacytoid Urothelial Carcinoma Invasive Bladder Sarcomatoid Urothelial Carcinoma Invasive Bladder Urothelial Carcinoma Kidney Medullary Carcinoma Large Cell Neuroendocrine Carcinoma Malignant Testicular Leydig Cell Tumor Malignant Testicular Sertoli Cell Tumor Metastatic Bladder Carcinoma Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma Metastatic Bladder Giant Cell Urothelial Carcinoma Metastatic Bladder Large Cell Neuroendocrine Carcinoma Metastatic Bladder Lipid-Rich Urothelial Carcinoma Metastatic Bladder Micropapillary Urothelial Carcinoma Metastatic Bladder Plasmacytoid Urothelial Carcinoma Metastatic Bladder Sarcomatoid Urothelial Carcinoma Metastatic Bladder Small Cell Neuroendocrine Carcinoma Metastatic Bladder Squamous Cell Carcinoma Metastatic Chromophobe Renal Cell Carcinoma Metastatic Kidney Medullary Carcinoma Metastatic Malignant Genitourinary System Neoplasm Metastatic Papillary Renal Cell Carcinoma Metastatic Penile Carcinoma Metastatic Prostate Small Cell Neuroendocrine Carcinoma Metastatic Sarcomatoid Renal Cell Carcinoma Metastatic Urethral Carcinoma Papillary Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage IV Bladder Cancer AJCC v8 Stage IV Penile Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IV Urethral Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Urachal Adenocarcinoma Urethral Clear Cell Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
314 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
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About This Trial
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least: * One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 * One bone lesion on bone scan (tec…
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