Clinical Trial

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Study acronym: EV-302
Active, Not 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 to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Protocol Amendment History 88 amendments
This ClinicalTrials.gov record has been amended 88 times since 2020-01-08; most recent amendment 2026-05-27.
Status change: Recruiting → Active, Not Recruiting 2024-06-28
Status change: Not Yet Recruiting → Recruiting 2020-03-20
Trial Details
NCT Number NCT04223856
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Merck Sharp & Dohme LLC, Seagen Inc.
Conditions Urothelial Cancer
Enrollment 886 participants
Start Date 2020-03-30
Primary Completion 2023-08-08 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-29