Étude ENGOT-en11

Recrutement terminé / Suivi

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



Recrutement terminé / Suivi


Schéma de l'étude 





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 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.  

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Modifié le 14-12-2021 09:18:11