Only 140 spots left

~140 spots leftby Apr 2026

Rucaparib + Nivolumab for Ovarian Cancer
(ATHENA Trial)

Recruiting in Palo Alto (17 mi)

+248 other locations

Overseen byRebecca Kristeleit, Bsc MBChB FRCP PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ppharmaand GmbH

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Keiichi Fujiwara, MD, PhD

Principal Investigator

Lead Investigator for Asia

Bradley Monk, MD, FACS, FACOG

Principal Investigator

Lead Investigator and Coordinating Investigator for North America

Rebecca Kristeleit, Bsc MBChB FRCP PhD

Principal Investigator

Coordinating Investigator for Europe and the Middle East

Eligibility Criteria

This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who've had surgery and responded to first-line platinum-based chemotherapy. It's not for those with autoimmune diseases, other active cancers, brain metastases, prior treatments besides platinum chemo, lung conditions or on high-dose steroids/immunosuppressants.

Inclusion Criteria

My tumor can be tested with enough tissue.

I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.

I am at least 20 years old in Japan, Taiwan, or South Korea, or at least 18 in other countries.

See 3 more

Exclusion Criteria

My cancer is a type of sarcoma, borderline tumor, or mucinous tumor.

I have another type of cancer that is currently active.

I am currently taking more than 10 mg of prednisone daily or other immunosuppressive drugs.

See 4 more

Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Rucaparib (PARP Inhibitor)

Trial OverviewThe study tests Rucaparib and Nivolumab as maintenance treatments after initial success with chemotherapy in ovarian cancer patients. It's a Phase 3 trial where participants are randomly assigned to receive either the drugs or placebo without knowing which one they're getting.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Japanese Open-label Safety CohortExperimental Treatment2 Interventions

Oral rucaparib + IV nivolumab

Group II: Arm CExperimental Treatment2 Interventions

Oral placebo + IV nivolumab

Group III: Arm BExperimental Treatment2 Interventions

Oral rucaparib + IV placebo

Group IV: Arm AExperimental Treatment2 Interventions

Oral rucaparib + intravenous (IV) nivolumab

Group V: Arm DPlacebo Group2 Interventions

Oral placebo + IV placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

ppharmaand GmbH

Lead Sponsor

Trials

Recruited

1,900+

pharmaand GmbH

Lead Sponsor

Trials

Recruited

4,300+

Clovis Oncology, Inc.

Lead Sponsor

Trials

Recruited

11,100+

Patrick J. Mahaffy

Clovis Oncology, Inc.

Chief Executive Officer since 2009

BA from Haverford College, MBA from Columbia University

Lindsey Rolfe

Clovis Oncology, Inc.

Chief Medical Officer since 2015

Specialist accreditation in pharmaceutical medicine

zr Pharma & GmbH

Lead Sponsor

Trials

Recruited

4,200+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis