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A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscleinvasive Bladder Cancer (KEYNOTE-905)

- Objective: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), based on central pathologic review, evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. - Hypothesis (H1): Preoperative pembrolizumab plus RC+PLND will achieve superior pCR rates, based on central pathologic review compared with RC+PLND alone, in participants whose tumors express PD-L1 CPS ≥10. - Hypothesis (H2): Preoperative pembrolizumab plus RC+PLND will achieve superior pCR rates based on central pathologic review, compared with RC+PLND alone, in all participants, irrespective of CPS score. - Objective: To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. - Hypothesis (H3): Perioperative pembrolizumab plus RC+PLND will achieve superior EFS compared with RC+PLND alone, in participants whose tumors express PD-L1 CPS ≥10. - Hypothesis (H4): Perioperative pembrolizumab plus RC+PLND will achieve superior EFS compared with RC+PLND alone, in all participants, irrespective of CPS score.

- Objective: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), based on central pathologic review, evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. - Hypothesis (H1): Preoperative pembrolizumab plus RC+PLND will achieve superior pCR rates, based on central pathologic review compared with RC+PLND alone, in participants whose tumors express PD-L1 CPS ≥10. - Hypothesis (H2): Preoperative pembrolizumab plus RC+PLND will achieve superior pCR rates based on central pathologic review, compared with RC+PLND alone, in all participants, irrespective of CPS score. - Objective: To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. - Hypothesis (H3): Perioperative pembrolizumab plus RC+PLND will achieve superior EFS compared with RC+PLND alone, in participants whose tumors express PD-L1 CPS ≥10. - Hypothesis (H4): Perioperative pembrolizumab plus RC+PLND will achieve superior EFS compared with RC+PLND alone, in all participants, irrespective of CPS score.