Rucaparib + Nivolumab for Ovarian Cancer (ATHENA Trial)

Palo Alto (17 mi)

Overseen byKeiichi Fujiwara, MD, 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.

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

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

I've had surgery to remove my ovaries and part of the lining of my abdomen.

I am fully active or can carry out light work.

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.

I have lung scarring or inflammation.

I have brain metastases.

I have only had the initial platinum treatment for my ovarian cancer.

I have an autoimmune disease.

Treatment Details

The 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.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm CExperimental Treatment2 Interventions

oral placebo+ IV nivolumab

Group II: Arm BExperimental Treatment2 Interventions

oral rucaparib+IV placebo

Group III: Arm AExperimental Treatment2 Interventions

oral rucaparib + intravenous (IV) nivolumab

Group IV: Arm DPlacebo Group2 Interventions

Oral placebo + IV placebo