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A Phase 3 Trial of Peri-operative Pembrolizumab + Neoadjuvant Chemotherapy vs. Placebo + Neoadjuvant Chemotherapy for Cis-Eligible MIBC

Primary: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab plus neoadjuvant chemotherapy plus Radical Cystectomy (RC) plus Pelvis Lymph Node Dissection [PLND]) and Arm B (preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), based on central pathology review, in participants whose tumors express programmed death ligand 1 (PD-L1) combined positive score (CPS) greater than or less than 10 and in all participants, irrespective of CPS score Hypothesis (H1): Preoperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior pCR rates, based on central pathology review, compared with preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H2): Preoperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior pCR rates, based on central pathology review, compared with preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Objective: To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND) and Arm B (perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), evaluated in participants whose tumors express PD-L1 CPS greater than or equal to 10 and in all participants, irrespective of CPS score. Hypothesis (H3): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior EFS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H4): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior EFS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Secondary: Objective: To compare the overall survival (OS) between Arm A (perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND) and Arm B (perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), evaluated in participants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Hypothesis (H5): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior OS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H6): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior OS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Objective: To assess disease-free survival (DFS) in participants from Arm A and Arm B, who are disease free after surgery based on participants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Objective: To compare the rate of pathologic downstaging (pDS) between Arm A and Arm B, evaluated in particpants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Objective: To evaluate the safety and tolerability of pembrolizumab plus chemotherapy plus RC plus PLND. Objective: To evaluate changes in patient reported outcomes from baseline and time to deterioration (TTD) using the Functional Assessment of Cancer Therapy (FACT)-B1-Cys instrument.

Primary: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab plus neoadjuvant chemotherapy plus Radical Cystectomy (RC) plus Pelvis Lymph Node Dissection [PLND]) and Arm B (preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), based on central pathology review, in participants whose tumors express programmed death ligand 1 (PD-L1) combined positive score (CPS) greater than or less than 10 and in all participants, irrespective of CPS score Hypothesis (H1): Preoperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior pCR rates, based on central pathology review, compared with preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H2): Preoperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior pCR rates, based on central pathology review, compared with preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Objective: To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND) and Arm B (perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), evaluated in participants whose tumors express PD-L1 CPS greater than or equal to 10 and in all participants, irrespective of CPS score. Hypothesis (H3): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior EFS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H4): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior EFS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Secondary: Objective: To compare the overall survival (OS) between Arm A (perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND) and Arm B (perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), evaluated in participants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Hypothesis (H5): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior OS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in participants whose tumors express PD-L1 CPS greater than or equal to 10. Hypothesis (H6): Perioperative pembrolizumab plus neoadjuvant chemotherapy plus RC plus PLND will achieve superior OS compared with perioperative placebo plus neoadjuvant chemotherapy plus RC plus PLND in all participants, irrespective of CPS score. Objective: To assess disease-free survival (DFS) in participants from Arm A and Arm B, who are disease free after surgery based on participants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Objective: To compare the rate of pathologic downstaging (pDS) between Arm A and Arm B, evaluated in particpants whose tumors express PD-L1 CPS greater than or equal to 10 and all participants, irrespective of CPS score. Objective: To evaluate the safety and tolerability of pembrolizumab plus chemotherapy plus RC plus PLND. Objective: To evaluate changes in patient reported outcomes from baseline and time to deterioration (TTD) using the Functional Assessment of Cancer Therapy (FACT)-B1-Cys instrument.