A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)
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ClinicalTrials.gov Identifier: NCT03522246 |
Recruitment Status :
Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : October 30, 2020
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Sponsor:
Clovis Oncology, Inc.
Collaborators:
Bristol-Myers Squibb
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
Tracking Information | ||||||||||
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First Submitted Date ICMJE | April 9, 2018 | |||||||||
First Posted Date ICMJE | May 11, 2018 | |||||||||
Last Update Posted Date | October 30, 2020 | |||||||||
Actual Study Start Date ICMJE | May 14, 2018 | |||||||||
Estimated Primary Completion Date | December 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 7 years) ] | |||||||||
Original Primary Outcome Measures ICMJE |
Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 10 years) ] | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy | |||||||||
Official Title ICMJE | 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. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Double-Blind Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||
Estimated Enrollment ICMJE |
1000 | |||||||||
Original Estimated Enrollment ICMJE |
1012 | |||||||||
Estimated Study Completion Date ICMJE | December 30, 2030 | |||||||||
Estimated Primary Completion Date | December 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Denmark, Finland, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03522246 | |||||||||
Other Study ID Numbers ICMJE | CO-338-087/GOG-3020/ENGOT-ov45 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Clovis Oncology, Inc. | |||||||||
Study Sponsor ICMJE | Clovis Oncology, Inc. | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Clovis Oncology, Inc. | |||||||||
Verification Date | October 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |