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

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.

Trial Details

NCT ID
NCT05009082
Phase
PHASE3
Sponsor
AGO Study Group
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Carboplatin
  • Paclitaxel
  • Bevacizumab
  • Niraparib
Locations (sample)
  • Amberg, Germany|49.44287,11.86267
  • Augsburg, Germany|48.37154,10.89851
  • Bad Homburg, Germany|50.22683,8.61816
  • Berlin, Germany|52.52437,13.41053
  • Bielefeld, Germany|52.03333,8.53333

Key Eligibility Criteria

  • Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awaren…
  • Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cance…
  • All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
  • Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of…

For full eligibility, visit ClinicalTrials.gov.

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