Titre A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy
Protocole ID MK-2870-005 (ENGOT-en23/GOG-3095)
ClinicalTrials.gov ID NCT06132958
Type(s) de cancer Endomètre
Phase Phase III
Type étude Clinique
Médicament Sacituzumab tirumotecan versus traitement au choix du physicien
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr à venir
Coordonnateur(trice)
Statut Actif en recrutement
Date d'activation 07-05-2024
Critètes d'éligibilité
  • Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
  • Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
  • Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
Critètes d'exclusion
  • Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
  • Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting.
  • Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.