A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Sponsor: pharmaand GmbH
ClinicalTrials ID:NCT03522246
This Phase 3 study assesses rucaparib and nivolumab as maintenance therapy in advanced ovarian cancer post-platinum chemotherapy. Eligible patients have completed surgery and chemotherapy with a response, possess sufficient tumor tissue, and have an ECOG status of 0 or 1. Interventions include oral rucaparib, IV nivolumab, and corresponding placebos.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | 85016 | Phoenix | Arizona |
| Arizona Oncology Associates, PC - HOPE | 85711 | Tucson | Arizona |
| The University of Arizona Cancer Center | 85724 | Tucson | Arizona |
| John Muir Clinical Research Center | 94520 | Concord | California |
| UCLA Women's Health Clinical Research Unit | 90095 | Los Angeles | California |
| Kaiser Permanente Northern California | 94589 | San Francisco | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Rocky Mountain Cancer Centers | 80228 | Lakewood | Colorado |
| Yale University | 06520 | New Haven | Connecticut |
| Florida Gynecologic Oncology | 33905 | Fort Myers | Florida |
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