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)
Phase 3
Active, not recruiting
NCT03924895
| Condition | Urinary Bladder Cancer, Muscle-invasive |
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| Phase | Phase 3 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Active, not recruiting |
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| Enrollment | 595 participants |
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| Interventions | Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin |
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| Start date | Jul 24, 2019 |
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| Completion date | Jun 6, 2025 |
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| Results posted | Jun 30, 2026 |
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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 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. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone
Up to approximately 53 months · Months
| Arm B: Surgery Alone | 15.7 Months |
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| Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery | NA Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.40 (95% CI 0.28–0.57) |
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Open in BENITIONS
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