Phase IIb Study of Cabozantinib and Enfortumab Vedotin for Advanced or Metastatic Urothelial Cancer

What this Trial Is About

Researchers are studying a combination of two drugs, cabozantinib and enfortumab vedotin, in adults with locally advanced or metastatic urothelial cancer, which is a type of bladder cancer that has spread to nearby tissues, lymph nodes, or other parts of the body. This phase IIb trial aims to find the best dose, assess possible benefits, and monitor side effects of this drug combination. Cabozantinib works by blocking enzymes needed for tumor cell growth, while enfortumab vedotin targets tumor cells specifically to deliver a toxic agent that kills them. In this study, patients take cabozantinib by mouth once daily during a 28-day cycle and receive enfortumab vedotin intravenously on days 1, 8, and 15 of each cycle. The cycles repeat every 28 days as long as the disease does not progress or side effects remain acceptable. The study includes a dose-escalation phase to find the recommended dose and a dose-expansion phase to further evaluate safety and tolerability. Participants will be closely monitored throughout the study with follow-up visits 30 days after treatment ends and then every 12 weeks. Researchers will assess side effects, tumor response using standardized criteria, progression-free survival, overall survival, and quality of life. They will also study drug effects on biomarkers and the gut microbiome. The study is expected to last up to five years for safety evaluations.

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer