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Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

NCT03651206 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-12-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • ARCAGY/ GINECO GROUP

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • France
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651206 on ClinicalTrials.gov