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 (ROCSAN)

NCT03651206 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	ARCAGY/ GINECO GROUP
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	138
Start date	2020-07-15
Completion	2027-06

Conditions

• Ovarian Carcinosarcoma
• Endometrial Carcinosarcoma

Interventions

• Niraparib
• Niraparib + TSR-042 (Dostarlimab)
• Chemotherapy Drugs

Primary outcomes

• Response Rate (RR) at 4 months — 4 months after the last patient included
  RR is defined as the proportion of patients with a partial response or complete response 4 months after randomization
• Overall survival (OS) — 1 year after the last patient included
  OS is the time from the date of the randomization until death due to any cause

Countries

France, Italy, Spain