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

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

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224597

Enrollment

100

Registered

2019-03-15

Start date

2019-02-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

investigational material(s) Generic name etc : Nivolumab INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Have newly diagnosed, advanced (FIGO stage III-IV),high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. 2. 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). 3. Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator. 4. Have sufficient tumor tissue for planned analyses. 5. Have an ECOG performance status of 0 to 1.

Exclusion criteria

Exclusion criteria: 1.Pure sarcomas or borderline tumors or mucinous tumors. 2.Active second malignancy 3.Known central nervous system brain metastases. 4.Any prior treatment for ovarian cancer, other than the first-line platinum regimen, 5.Evidence of interstitial lung disease, active pneumonitis, 6.Active, known or suspected autoimmune disease 7.Condition requiring active systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications

Design outcomes

Primary

Measure	Time frame
efficacy Investigator assessed Progression-free survival (PFS)	—

Secondary

Measure	Time frame
safety efficacy 1.PFS by RECIST, as assessed by the Blinded Independent central review (BICR), in molecularly-defined HRD subgroups 2.Overall Survival (OS) 3.Objective response rate (ORR) and Duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline 4.Number of participants with treatment-emergent Adverse events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability 5.Number of participants with serious AEs as a measure of safety and tolerability 6.Number of participants with laboratory abnormalities as a measure of safety and tolerability	—

Measure

Time frame

safety efficacy 1.PFS by RECIST, as assessed by the Blinded Independent central review (BICR), in molecularly-defined HRD subgroups 2.Overall Survival (OS) 3.Objective response rate (ORR) and Duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline 4.Number of participants with treatment-emergent Adverse events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability 5.Number of participants with serious AEs as a measure of safety and tolerability 6.Number of participants with laboratory abnormalities as a measure of safety and tolerability

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Contacts

Public ContactShoji KAGIYAMA

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-3-6779-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026