Perioperative Pembrolizumab Plus Cystectomy or Perioperative Pembrolizumab Plus EV Plus Cystectomy Vs Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Brief Summary:
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior pathologic complete response (pCR) rates (based on central pathologic review) and event-free survival (EFS) compared with RC+PLND alone.
With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 857 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Actual Study Start Date: July 24, 2019
Estimated Primary Completion Date: May 31, 2027
Estimated Study Completion Date: December 15, 2027
Arm:
- Experimental: Pembrolizumab + Surgery
- Active Comparator: Surgery alone
- Experimental: Enfortumab Vedotin + Pembrolizumab + Surgery
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 857 |
| Actual Study start date | 24 July 2019 |
| Estimated Study Completion Date | 15 December 2027 |