Clinical trial · Interventional
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)
NCT03522246CI-TRIAL-00091271ATHENAactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complete Response | — | UNRESOLVED | — |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| FIGO Stage III-IV | — | UNRESOLVED | — |
| Newly Diagnosed | — | UNRESOLVED | — |
| Partial Response | — | UNRESOLVED | — |
| Primary Peritoneal | — | UNRESOLVED | — |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Oral rucaparib + intravenous (IV) nivolumab
- interventionNames
- Drug: Rucaparib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Oral rucaparib + IV placebo
- interventionNames
- Drug: Rucaparib
- Drug: Placebo IV Infusion
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Oral placebo + IV nivolumab
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDKristeleit RS, Ghamande S, Lisyanskaya A, Oaknin A, Prendergast E, Kim YB, Fuentes Pradera J, Littell RD, Gao B, Valabrega G, O'Malley DM, Dean A, Pisano C, Buscema J, Provencher D, Zagouri F, Martin LP, Chou HH, Demirkiran F, Ueland F, Chudecka-Glaz A, Yeku O, Beiner M, Anderson C, Drochytek V, Eskander RN, Agarwal R, Maloney L, Despain D, Connor C, Craib M, Shih D, Fujiwara K, Monk BJ. Rucaparib maintenance for newly diagnosed advanced ovarian cancer: interim overall survival, progression-free survival, and safety at 5 years of follow-up from the phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 study. Ann Oncol. 2026 Feb;37(2):217-228. doi: 10.1016/j.annonc.2025.10.007. Epub 2025 Oct 18. PMID 41115469
- DERIVEDMonk BJ, Parkinson C, Lim MC, O'Malley DM, Oaknin A, Wilson MK, Coleman RL, Lorusso D, Bessette P, Ghamande S, Christopoulou A, Provencher D, Prendergast E, Demirkiran F, Mikheeva O, Yeku O, Chudecka-Glaz A, Schenker M, Littell RD, Safra T, Chou HH, Morgan MA, Drochytek V, Barlin JN, Van Gorp T, Ueland F, Lindahl G, Anderson C, Collins DC, Moore K, Marme F, Westin SN, McNeish IA, Shih D, Lin KK, Goble S, Hume S, Fujiwara K, Kristeleit RS. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022 Dec 1;40(34):3952-3964. doi: 10.1200/JCO.22.01003. Epub 2022 Jun 6. PMID 35658487
- DERIVEDMonk BJ, Coleman RL, Fujiwara K, Wilson MK, Oza AM, Oaknin A, O'Malley DM, Lorusso D, Westin SN, Safra T, Herzog TJ, Marme F, N Eskander R, Lin KK, Shih D, Goble S, Grechko N, Hume S, Maloney L, McNeish IA, Kristeleit RS. ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer. Int J Gynecol Cancer. 2021 Dec;31(12):1589-1594. doi: 10.1136/ijgc-2021-002933. Epub 2021 Sep 30. PMID 34593565