A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)
- Conditions
- ovarian cancer
- Registration Number
- JPRN-jRCT2080224597
- Lead Sponsor
- Clovis Oncology,Inc./ CMIC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 100
1. Have newly diagnosed, advanced (FIGO stage III-IV),high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
2. 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).
3. Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator.
4. Have sufficient tumor tissue for planned analyses.
5. Have an ECOG performance status of 0 to 1.
1.Pure sarcomas or borderline tumors or mucinous tumors.
2.Active second malignancy
3.Known central nervous system brain metastases.
4.Any prior treatment for ovarian cancer, other than the first-line platinum regimen,
5.Evidence of interstitial lung disease, active pneumonitis,
6.Active, known or suspected autoimmune disease
7.Condition requiring active systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method