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

• Status: Active, not recruiting
• Trial end date: 2030-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborators: Bristol-Myers Squibb; European Network of Gynaecological Oncological Trial Groups (ENGOT); Foundation Medicine; Gynecologic Oncology Group
• Treatments: Antibodies, Monoclonal; Nivolumab; Rucaparib

Criteria

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