OncoMatch/Clinical Trials/NCT03866382
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Is NCT03866382 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for bladder adenocarcinoma.
Treatment: Cabozantinib S-malate · Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Renal Cell Carcinoma
Urothelial Carcinoma
Penile Carcinoma
Prostate Cancer
Disease stage
Metastatic disease required
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
Prior therapy
Must have received: platinum-based chemotherapy
Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment
Must have received: cisplatin-based chemotherapy
Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)
Cannot have received: cabozantinib (cabozantinib)
prior cabozantinib will not be allowed
Cannot have received: combined MET/VEGF and PD-1/PD-L1/CTLA-4 therapy
patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed
Cannot have received: PD-1/PD-L1 axis or anti-CTLA-4 therapy
Exception: patients with 'urothelial carcinoma' histology (cohorts D, H, J, L)
No prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4/CTLA-4 inhibitors with the exception of patients with 'urothelial carcinoma' histology (cohorts D, H, J, L)
Lab requirements
Blood counts
ANC >= 1,000/mcL; Platelet count >= 75,000/mcL; Hemoglobin >= 9 g/dL (transfusion allowed)
Kidney function
Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 (CKD-EPI or Cockcroft-Gault)
Liver function
Total bilirubin =< 1.5 x ULN (or =< 3.0 mg/dL for Gilbert's); AST/ALT =< 3.0 x ULN (or =< 5 x ULN for liver metastases or Gilbert's); serum albumin >= 3.2 g/dL
Cardiac function
No CHF NYHA class III/IV; no uncontrolled hypertension (BP > 150/90 mmHg); QTcF <= 500 ms; no congenital long QT syndrome; no unstable angina, significant arrhythmias, stroke/TIA, MI, cardiomyopathy within 6 months
Absolute neutrophil count (ANC) >= 1,000/mcL; Platelet count >= 75,000/mcL; Total bilirubin =< 1.5 x ULN (or =< 3.0 mg/dL for Gilbert's); AST/ALT =< 3.0 x ULN (or =< 5 x ULN for liver metastases or Gilbert's); Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2; Hemoglobin >= 9 g/dL; Serum albumin >= 3.2 g/dL; Lipase and amylase =< 2.0 x ULN; No cardiovascular disorders as specified.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC-Passavant Hospital · Pittsburgh, Pennsylvania
- UPMC-Saint Clair Hospital Cancer Center · Pittsburgh, Pennsylvania
- Wexford Health and Wellness Pavilion · Wexford, Pennsylvania
- Medical University of South Carolina · Charleston, South Carolina
- University Cancer Specialists - Alcoa · Alcoa, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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