Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT03651206
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Endometrial Carcinosarcoma
  • Ovarian Carcinosarcoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 15, 2020
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Niraparib
    Niraparib, 200 mg or 300 mg, daily dose
  • Experimental: Arm B - Niraparib + TSR-042 (Dostarlimab)
    Niraparib, 200 mg or 300 mg, daily dose TSR042, intravenous infusion on Day 1 of every 21-day cycle at 500 mg for the 4 first cycles, followed by 1,000 mg on Day 1 of every 42-day cycle thereafter
  • Active Comparator: Arm C - Chemotherapy drugs
    Chemotherapies (Standard of care) For Ovarian Cancer Patients Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Pegylated Liposomal Doxorubicin, 40 mg/m², Intravenous, every 28 days Topotecan, 4mg/m², Intravenous, Day 1, 8, 15 every 28 days For Endometrial Cancer Patients Doxorubicin, 60 mg/m², Intravenous, every 21 days Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Gemcitabine, 800 mg/m², Intravenous, Day 1, 8 every 21 days

Primary Outcome Measure

Response Rate (RR) at 4 months [ Time Frame: 4 months after the last patient included ]

Central Contacts

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