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GOG-3020

Trial

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

December 31, 2018

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

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:48 PM