A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Brief Title

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Official 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)

Brief Summary

      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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Investigator assessed Progression-free survival (PFS)

Secondary Outcome

 Blinded independent central review (BICR) PFS

Condition

Epithelial Ovarian Cancer

Intervention

Rucaparib

Study Arms / Comparison Groups

 Arm A

Description:  oral rucaparib + intravenous (IV) nivolumab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 14, 2018

Completion Date

December 30, 2030

Primary Completion Date

December 30, 2024

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bradley Monk, MD, FACS, FACOG, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT03522246

Organization ID

CO-338-087/GOG-3020/ENGOT-ov45

Responsible Party

Sponsor

Study Sponsor

Clovis Oncology, Inc.

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Bradley Monk, MD, FACS, FACOG, Principal Investigator, Lead Investigator and Coordinating Investigator for North America

Verification Date

October 2020