Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Official Title

A Phase 3 Randomized Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905)

Summary:

A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Trial Description

Primary Outcome:

• Pathologic Complete Response (pCR) Rate in All Participants
• Pathologic Complete Response Rate in Participants Whose Tumours Express PD-L1 Combined Positive Score (CPS) ≥10
• Event-Free Survival (EFS) in All Participants
• Event-Free Survival in Participants Whose Tumours Express PD-L1, CPS ≥10

• Overall Survival (OS) in All Participants
• Overall Survival in Participants Whose Tumours Express PD-L1, CPS ≥10
• Disease-Free Survival (DFS) in All Participants
• Disease-Free Survival in Participants Whose Tumours Express PD-L1, CPS ≥10
• Pathologic Downstaging (pDS) Rate in All Participants
• Pathologic Downstaging (pDS) Rate in Participants Whose Tumours Express PD-L1, CPS ≥10
• Number of Participants Experiencing Adverse Events (AEs)
• Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
• Number of Participants Experiencing Perioperative Complications

View this trial on ClinicalTrials.gov