Groupe d'Etude en Oncologie du Quebec

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	CIUSSS DU SAGUENAY – LAC-SAINT-JEAN HOPITAL DE CHICOUTIMI 305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
Ville	Chicoutimi
Investigateur(trice) principal(e)	Dr José Luiz Miranda Guimaraes
Coordonnateur(trice)	Sabrina Côté 418-541-1000 poste 3065
Statut	Actif en recrutement
Date d'activation	29-05-2024
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.

Groupe d'étude en oncologie du Québec