A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

Inclusion criteria

• ✓. Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• ✓. Female patient, age ≥ 18 years.
• ✓. FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
• ✓. Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
• ✓. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \>83 independent of BRCA status, based on these results.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• ✓. Patients must be able to take oral medications.
• ✓. Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial.

Exclusion criteria