Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) \< 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is \<20%, progression-free survival (PFS) \<4 months, and OS \<1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

NCT Number	NCT03651206
Lead Sponsor	ARCAGY/ GINECO GROUP Collaborators: Tesaro, Inc.
Conditions	Ovarian Carcinosarcoma, Endometrial Carcinosarcoma
Enrollment	138 participants
Start Date	2020-07-15
Primary Completion	2027-06 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-01