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Trial Summary

Protocol No.CTO-MK-3475-905
Principal InvestigatorAdra, Nabil
PhasePhase III
Age GroupAdult
TitleA Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Participants who are Cisplatin-Ineligible or Decline Cisplatin with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
DescriptionA global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Clinically non-metastatic bladder cancer determined by imaging
  • Adequate organ function
For a full list of participation criteria, please visit
Applicable Disease SitesUrinary Bladder
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632