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 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.
Eligibility criteria
Qualifiers
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.
Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded
Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization [WHO] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Scan
- Cabozantinib S-malate
- Computed Tomography
- Echocardiography Test
- Ipilimumab
- Magnetic Resonance Imaging
- Nivolumab
- Positron Emission Tomography
Treatment groups
Locations
581Sponsors and collaborators
National Cancer Institute (NCI)
Lead sponsor