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)

Brief description of study

This is a randomized, comparator-controlled, parallel-group, multi-site, open-label study of pembrolizumab in combination with BCG in participants with HR NMIBC that is persistent or recurrent following BCG induction. Specific procedures to be performed during the study, as well as their prescribed times and associated visit windows, are outlined in the Schedule of Activities (SoA), Section 1.3. Details of each procedure are provided in Section 8. Approximately 550 participants with HR NMIBC that have persistent or recurrent disease after receiving adequate BCG induction (Section 5.1) will be randomized in a 1:1 ratio to receive BCG + pembrolizumab (Arm 1) or BCG alone (Arm 2). Participants with persistent T1 disease after induction BCG are not eligible. Participants will be stratified based on the presence or absence of CIS in tissue submitted during screening, PD-L1 combined positive score (CPS) =10 or <10, and NMIBC Disease History (persistent or recurrent NMIBC at 0 - =6 months, or recurrent NMIBC at >6 months to =12 months or recurrent NMIBC at >12 months to =24 months). To ensure approximately 368 of the planned 550 participants enrolled in the study have CIS, enrollment of non-CIS participants will be capped at approximately 182.


Clinical Study Identifier: s18-00374
ClinicalTrials.gov Identifier: NCT03711032
Principal Investigator: William C Huang.
Other Investigators: Victor Ricardo Adorno Febles, Wei Phin Tan, Minas Platon Economides, Katie S. Murray, Scot Niglio, Hank Ng, David R. Wise.


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