Phase 3 Trial Comparing Enfortumab Vedotin Plus Pembrolizumab With Standard Chemoradiotherapy for Bladder Preservation in Adults with Muscle-Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating how well the combination of enfortumab vedotin and pembrolizumab works compared to the standard concurrent chemoradiotherapy for treating adults with muscle-invasive bladder cancer MIBC that has not spread beyond the bladder. This phase 3 study focuses on bladder preservation and includes participants who have not had prior systemic treatments for this cancer. The study aims to compare these two approaches to see which better controls the disease and improves survival. Participants will be randomly assigned to one of two groups one receiving enfortumab vedotin plus pembrolizumab, and the other receiving standard chemoradiotherapy. Enfortumab vedotin is given as an intravenous infusion on Days 1 and 8 of each 3-week cycle, for up to 9 cycles. Pembrolizumab is given as an intravenous infusion on Day 1 of each 3-week cycle, for up to 17 cycles. The chemoradiotherapy group will receive radiation therapy to the bladder and possibly pelvic nodes over 6.5 weeks along with chemotherapy using drugs such as cisplatin, fluorouracil, mitomycin C, or gemcitabine as radiosensitizers. During the study, participants will be monitored closely with evaluations of bladder-intact event-free survival and overall survival up to approximately 45.5 and 60 months, respectively. Additional assessments include clinical responses, metastasis-free survival, and safety by tracking adverse events. Participants will undergo scans, laboratory tests, and clinical examinations as part of routine follow-up. The total participation may last several years to capture long-term outcomes and safety data.

Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)