CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,097 enrolled
Drug / intervention
Rucaparib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03522246
NCT03522246Phase 3Active
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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)

pharmaand GmbH·interventional·Posted May 11, 2018·Updated Jun 24, 2025

In Brief

A Phase 3 clinical trial evaluating Rucaparib, Nivolumab, and 2 other interventions for Epithelial Ovarian Cancer and 6 related conditions. Active but no longer recruiting, targeting 1,097 participants across 238 sites in 24 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Newly Diagnosed, FIGO Stage III-IV, Partial Response, Complete Response
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Japan, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsBristol-Myers Squibb, Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Foundation Medicine

Timeline

Phase 3Active
2019202020212022202320242025202620272028202920302031
First PostedMay 11, 2018
Enrollment StartMay 14, 2018
Primary CompletionMay 20, 2024
Study CompletionDec 30, 2030
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.1 years ago

Interventions

Rucaparibdrug

Oral rucaparib will be administered twice daily

Nivolumabdrug

IV nivolumab will be administered once every 4 weeks

Placebo Oral Tabletdrug

Placebo tablets will be administered twice daily

Placebo IV Infusiondrug

IV placebo will be administered once every 4 weeks