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

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

Trial Details

NCT ID
NCT03866382
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Papillary Renal Cell Carcinoma Kidney Cancer
Interventions
  • Biospecimen Collection
  • Bone Scan
  • Cabozantinib S-malate
  • Computed Tomography
  • Echocardiography Test
  • Ipilimumab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Kingman, Arizona, United States|35.18944,-114.05301
  • Scottsdale, Arizona, United States|33.50921,-111.89903

Key Eligibility 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:

For full eligibility, visit ClinicalTrials.gov.

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