| Title |
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 |
| Cancer Type(s) |
Uterus Lining |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Sacituzumab tirumotecan versus traitement au choix du physicien |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
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| Principal Investigator |
Dr. à venir
|
| Coordinator |
|
| Status |
Recruiting |
| Activation Date |
07-05-2024 |
| Eligibility Criteria |
- 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.
|
| Exclusion Criteria |
- 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.
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Groupe d'étude en oncologie du Québec