A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
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.
Timeline
- Start
- 2018-05-14
- Primary completion
- 2024-05-20
- Completion
- 2030-12-30
Outcome
Mixed primary results
registry Arm B: Rucaparib + Placebo vs Arm D: Placebo + Placebo; p = 0.0004; Hazard Ratio (HR) 0.47 (95% CI 0.31 to 0.72) NCT03522246 ↗
registry Arm B: Rucaparib + Placebo vs Arm D: Placebo + Placebo; p <0.0001; Hazard Ratio (HR) 0.52 (95% CI 0.40 to 0.68) NCT03522246 ↗
registry Arm A: Rucaparib + Nivolumab vs Arm B: Rucaparib + Placebo; p = 0.0038; Hazard Ratio (HR) 1.29 (95% CI 1.08 to 1.53) NCT03522246 ↗
Publications
- Kristeleit 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.
- Monk 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.
- Monk 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.