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)
第3相
実施中（募集終了）
NCT03924895
| 対象疾患 | Urinary Bladder Cancer, Muscle-invasive |
|---|
| 相 | 第3相 |
|---|
| スポンサー | Merck Sharp & Dohme LLC |
|---|
| ステータス | 実施中（募集終了） |
|---|
| 参加者数 | 595 名 |
|---|
| 介入（薬剤） | Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin |
|---|
| 開始日 | 2019年7月24日 |
|---|
| 完了日 | 2025年6月6日 |
|---|
| 結果公開日 | 2026年6月30日 |
|---|
概要
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 |
|---|
| Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery | NA Months |
|---|
| p-value | <0.0001 |
|---|
| Hazard Ratio (HR) | 0.40 (95% CI 0.28–0.57) |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。