Étude ENGOT-en11

Fiche descriptive de l'étude

Étude Endomètre

Étude ENGOT-en11

Titre de l'étude

ENGOT-en11 : A Phase 3, Randomized, Double‐Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High‐Risk Endometrial Cancer After Surgery With Curative Intent

Statut

Recrutement terminé / Suivi

Schéma de l'étude 

Promoteur

MSD

But

Objectif principal :

Disease Free survival as assessed radiographically by the investigator or by pathologic confirmation and Overall Survival

Objectif secondaire : 

Disease Free survival as assessed radiographically by blinded independent central review (BICR) or by pathologic confirmation and Disease Free Survival at 2 years assessed by investigator and assessed by BICR. Overall Survival at 3 years. Adverse events.

Phase

Phase III

Type de patiente

Patients with newly diagnosed, high-risk endometrial cancer (no prior radiation or systemic therapy for EC including neoadjuvant therapy).

Nombre de patientes recrutées

•  1090 patientes à l'international dans 220 centres
• 48 patientes en France dans 12 centres

Critères principaux d’évaluation

For DFS : The time from randomization to local or distant recurrence of endrometrial cancer, or death due to any cause, whichever occurs first.  For OS : the time from randomization to death due to any cause.