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)
3期
进行中（已停止招募）
NCT03924895
| 适应症 | Urinary Bladder Cancer, Muscle-invasive |
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| 分期 | 3期 |
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| 申办方 | Merck Sharp & Dohme LLC |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 595 人 |
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| 干预（药物） | Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin |
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| 开始日期 | 2019年7月24日 |
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| 完成日期 | 2025年6月6日 |
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| 结果公布日 | 2026年6月30日 |
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摘要
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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