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A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

Trial Profile

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Feb 2019

At a glance

  • Drugs Bladder cancer vaccine (Primary) ; Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms HR NMIBC; KEYNOTE-676; MK-3475-676/KEYNOTE-676
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 27 Dec 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 10 Dec 2018 to 31 Dec 2018.
    • 09 Dec 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 19 Nov 2018 to 10 Dec 2018.
    • 09 Dec 2018 Status changed from not yet recruiting to recruiting.
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