National Cancer Institute (NCI)
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 nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting for patients within each of the rare genitourinary (GU) variant histology group of interest, as measured by objective response rate (ORR). SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology. II. To estimate the overall survival (OS) for patients treated with cabozantinib combined with…
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 (tec99 or sodium fluoride \[NaF\] PET/CT, CT or MRI) for the bone-only cohort. * Histologically confirmed diagnosis of one of the following metastatic cohorts: * Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentia…
Undergo blood and urine sample collection
Undergo bone scan
Given PO
Undergo CT and/or PET/CT scan
Undergo echocardiography
Given IV
Undergo MRI
Given IV
Undergo PET/CT scan