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Trial Summary

Protocol No.CTO-MK-3475-866
Principal InvestigatorAdra, Nabil
PhasePhase III
Age GroupAdult
TitleA Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-866)
DescriptionA global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Participants whose tumors contain any neuroendocrine component are not eligible.
  • Urothelial carcinomas not originating from the bladder (e.g., upper tract [ureters, renal pelvis], urethra) are not eligible.
For a full list of participation criteria, please visit
Applicable Disease SitesUrinary Bladder
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632