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.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.