Type : | Industriel |
Statut : | Ouvert |
Phase : | III |
Étape du traitement : | Thérapie ciblée |
Date d'ouverture : | 21/04/2021 |
Date clôture : | 23/06/2026 |
Promoteur : | Merck Sharp & Dohme LLC |
Progression du cancer: | Loco-régional |
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
- Cancers uro-génitaux
- Vessie
- Tumeur maligne de la vessie - Cim10 : C67