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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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2019

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At a glance

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

    • 04 Jun 2019 Recruitment began in November 2018 and will continue until ~550 pts are enrolled
    • 04 Jun 2019 Trial design presented at the 55th Annual Meeting of the American Society of Clinical Oncology
    • 16 Feb 2019 Trial design presented at the 2019 Genitourinary Cancers Symposium
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