BACKGROUND: Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. PRIMARY OBJECTIVE: The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. STUDY HYPOTHESIS: This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. TRIAL DESIGN: This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. PRIMARY ENDPOINT: The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. SAMPLE SIZE: 427 patients will be randomized. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: June 2024 TRIAL REGISTRATION NUMBER: NCT04679064.

Department of Gynaecologic Oncology Charité Universitätsmedizin Berlin Berlin Germany

Department of Life Science and Public Health Catholic University of Sacred Heart Largo Agostino Gemelli Rome Italy

Department of Medical Oncology Institut de Cancerologie de l'Oust site Renè Gauducheau Saint Herblain France

Department of Obstetrics and Gynaecology General University Hospital Prague Czech Republic

Department of Urology and Gynecology Istituto Nazionale Tumori IRCCS Fondazione G Pascale Naples Italy

Department of Women and Child Health Division of Gynaecologic Oncology Policlinico Universitario Fondazione Agostino Gemelli IRCCS Rome Lazio Italy

Gynecologic Oncology Program; European Institute of Oncology IRCCS University of Milan Bicocca Milan Italy

Oncology Unit Department of Clinical Therapeutics National and Kapodistrian University of Athens Athens Greece

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NCT04679064