| TITRE |
(EN) 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) |
| CLINICAL TRIAL.gov ID |
NCT06132958 |
| TYPE(S) DE CANCER |
Endomètre |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
305, rue Saint-Vallier, CP 5006
|
| VILLE |
Chicoutimi
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
José Luiz Miranda Guimaraes
|
| COORDONATEUR(RICE) |
Sabrina Côté
sabrina.cote.inf@ssss.gouv.qc.ca
418-541-1000 poste 3065
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
