NCT03651206

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

An International Multicentric Randomized Phase II Evaluating Dostarlimab in Combination With Niraparib Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ovarian Carcinosarcoma
• Endometrial Carcinosarcoma

Interventions

Type	Name	Description
DRUG	Niraparib	PARP Inhibitor
COMBINATION_PRODUCT	Niraparib + TSR-042 (Dostarlimab)	Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1
DRUG	Chemotherapy Drugs	Chemotherapies given in standard of care

Timeline

• Start date: 2020-07-15
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2018-08-29
• Last updated: 2025-12-19

Locations

36 sites across 3 countries: France, Italy, Spain