GOG-3020

Clinical Trial Title 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)
Trial Status Closed to Enrollment
Start Date 01/01/2019
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description 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:

  • Have newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV), high-grade 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).
  • Have received 4 to 8 cycles of first line platinum-doublet treatment per standard clinical practice, including a minimum of 4 cycles of platinum/ taxane combination.
  •  a. A patient with best response of PR must have received at least 6 cycles.  
  •  b. Bevacizumab is allowed during the chemotherapy phase, but not during maintenance ie, during therapy directed by this protocol.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

 
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT03522246?term=gog+3020&cond=Ovarian+Cancer
Principal Investigator Colleen McCormick, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org