Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

Sponsor
AGO Study Group
Study ID
NCT05009082
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles
  • Paclitaxel — DRUG
    175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles
  • Bevacizumab — DRUG
    7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year starting from Cycle 7 Day 1
  • Niraparib — DRUG
    200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1

Study Details

This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.

Key Dates

Start date
Sep 13, 2022
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2031

Study Design

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

Arms

  • Active Comparator: Arm 1
    Chemotherapy followed by maintenance with niraparib
  • Active Comparator: Arm 2
    Chemotherapy in combination with bevacizumab followed by maintenance with bevacizumab and niraparib

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier ]

Central Contacts

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