Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE3

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)

NCT03522246•pharmaand GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (238)

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

John Muir Clinical Research Center

Concord, California, United States

UCLA Women's Health Clinical Research Unit

Los Angeles, California, United States

Kaiser Permanente Northern California

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Yale University

New Haven, Connecticut, United States

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Key Dates

Start Date

May 14, 2018

Primary Completion Date

May 20, 2024

Completion Date

December 30, 2030

Last Updated

June 24, 2025

Enrollment

1,097

ACTUAL participants

Conditions

Epithelial Ovarian CancerPrimary PeritonealFallopian Tube CancerNewly DiagnosedFIGO Stage III-IVPartial ResponseComplete Response

Interventions

Rucaparib

DRUG

Nivolumab

DRUG

Placebo Oral Tablet

DRUG

Placebo IV Infusion

DRUG

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

NCT05281471

Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian Cancer+5 more

View study

RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab