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
1000
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