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 Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in
combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is
either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve
to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of
pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central
pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary
hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced
maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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