Clinical Trial

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

Recruiting Phase 3
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Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.
Protocol Amendment History 2 changes
notable Trial sites expanded: 1 -> 9 locations 2026-06-09
critical Recruitment opened 2026-05-12
Trial Details
NCT Number NCT07566156
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Pfizer
Conditions Urothelial Cancer, Urinary Bladder Neoplasms
Enrollment 390 participants
Start Date 2026-05-11
Primary Completion 2030-03-31 (estimated)
Study Completion 2032-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-06