ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)
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.
Information coming soon.
Sex: FEMALE
Minimum Age: 18 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT
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