A Phase 3 Randomized Comparator-controlled Study of the Efficacy and Safety of Pembro in Comb. with BCG in Participants with HR Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction

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).

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