A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Purpose
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.
Conditions
- Epithelial Ovarian Cancer
- Primary Peritoneal
- Fallopian Tube Cancer
- Newly Diagnosed
- FIGO Stage III-IV
- Partial Response
- Complete Response
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-Blind
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Arm A |
oral rucaparib + intravenous (IV) nivolumab |
|
Experimental Arm B |
oral rucaparib+IV placebo |
|
Experimental Arm C |
oral placebo+ IV nivolumab |
|
Placebo Comparator Arm D |
Oral placebo + IV placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT03522246
- Status
- Active, not recruiting
- Sponsor
- pharmaand GmbH