A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Inclusion Criteria: * Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking) * Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator * Sufficient tumor tissue for planned analysis * ECOG performance status of 0 or 1 * Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent Exclusion Criteria: * Pure sarcomas or borderline tumors or mucinous tumors * Active second malignancy * Known central nervous system brain metastases * Any prior treatment for ovarian cancer, other than the first-line platinum regimen * Evidence of interstitial lung disease or active pneumonitis * Active, known or suspected autoimmune disease * Condition requiring active systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications