Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT05183984
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
  • Bevacizumab-Awwb — DRUG
    MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles. the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months.
  • Niraparib — DRUG
    niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.

Study Details

Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

Key Dates

Start date
Feb 1, 2022
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 1, 2032

Study Design

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

Arms

  • Experimental: ARM A: carboplatin/paclitaxel + niraparib
    carboplatin AUC 5-6 + paclitaxel 175 mg/m² q3w, 5 cycles, followed by niraparib 200\* or 300 mg/d for 2 years.
  • Experimental: ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab
    carboplatin AUC 5-6 + paclitaxel 175 mg/m² + bevacizumab 15 mg/kg q3w, 5 cycles, followed by bevacizumab 15 mg/kg q3w for 15 months + niraparib 200\*or 300 mg/d for 2 years.

Primary Outcome Measure

Progression-Free survival (PFS) rate up to 24 months [ Time Frame: Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first, assessed up to 24 months. ]

Central Contacts

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