Phase II Study of Cabozantinib Combined with Nivolumab and Ipilimumab for Rare Metastatic Genitourinary Cancers

What this Trial Is About

Researchers are evaluating the effectiveness of combining cabozantinib with two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare genitourinary tumors that have spread beyond their original site. This phase II study focuses on patients with various rare histological types of genitourinary cancers, aiming to assess how well this combination works compared to using each drug alone. The trial also aims to understand the safety of this treatment and to collect tissue samples and clinical data for further research. Participants receive cabozantinib orally once daily on days 1-21 of the first four cycles and continuously on days 1-28 of subsequent cycles. Nivolumab and ipilimumab are given intravenously on day 1 of the first four cycles, with nivolumab continuing as an IV infusion on day 1 of later cycles. Each treatment cycle lasts 21 days initially and 28 days thereafter, continuing for up to two years unless the disease progresses or unacceptable side effects occur. Patients may have scans such as CT, MRI, bone scans, and PETCT during the study and undergo blood and urine sample collections. Echocardiography is performed during screening. Throughout the study, participants are monitored with imaging tests and sample collections to track tumor response and safety. After completing treatment, patients have follow-up visits every two months for up to five years to observe long-term effects and survival. The main measure of success is the objective response rate, with additional assessments of progression-free survival, overall survival, clinical benefit, and adverse events. This extended monitoring helps researchers understand the lasting impact of the treatment combination.

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