A Phase 3 Randomized Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with BCG in Participants with HR NMIBC that is either Persistent or Recurrent Following BCG Induction or that is Na ve to BCG Treatment (KEYNOTE-676)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    High-risk Non-muscle Invasive Bladder Cancer
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Have histologically confirmed by BICR diagnosis of high-risk non-muscle invasive. 2) Have been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC defined as at least 5 intravesical instillations of BCG within a 10-week period of time. 3) Have undergone cystoscopy/TURBT to remove all resectable disease within 12 weeks prior to randomization.

You may not be eligible for this study if the following are true:

  • 1) Has persistent (remains present or occurs within 3 months (–2 weeks) to 6 months (+4 weeks) after start of BCG induction) T1 disease following an induction course of BCG. 2) Women of child bearing potential who has a positive urine pregnancy test within 72 hours prior to randomization. 3) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.