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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 14 → 19 locations Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 2 of 8 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 8 entries
  2. Study sites: 12 to 14v6
  3. Study sites: 11 to 12v5
  4. Study sites: 9 to 11v4
  5. Trial sites expanded: 1 → 9 locationsv3
  6. Recruitment opened Study sites: 0 to 1 · Eligibility criteria revisedv2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov