NCT03522246

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,097 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Primary Peritoneal
• Fallopian Tube Cancer
• Newly Diagnosed
• FIGO Stage III-IV
• Partial Response
• Complete Response

Interventions

Type	Name	Description
DRUG	Rucaparib	Oral rucaparib will be administered twice daily
DRUG	Nivolumab	IV nivolumab will be administered once every 4 weeks
DRUG	Placebo Oral Tablet	Placebo tablets will be administered twice daily
DRUG	Placebo IV Infusion	IV placebo will be administered once every 4 weeks

Timeline

• Start date: 2018-05-14
• Primary completion: 2024-05-20
• Completion: 2030-12-30
• First posted: 2018-05-11
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

238 sites across 24 countries: United States, Australia, 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

Regulatory

• FDA-regulated drug study