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Objective: This study assessed the efficacy, safety, and health-related quality of life (HRQoL) of the treatment regimen of dostarlimab, a programmed death-1 inhibitor, combined with niraparib, a poly (ADP-ribose) polymerase inhibitor, in patients with BRCA wild type (BRCAwt) recurrent platinum-resistant ovarian cancer (PROC) who had previously received bevacizumab treatment., Methods: This Phase II, open-label, single-arm, multicenter study, conducted in the USA, enrolled patients with recurrent PROC to receive niraparib and dostarlimab until disease progression or unacceptable toxicity (up to 3 years). A preplanned interim futility analysis was performed after the first 41 patients had undergone ≥1 radiographic evaluation (approximately 9 weeks from the first treatment)., Results: The prespecified interim futility criterion was met and the study was therefore terminated. For the 41 patients assessed, the objective response rate (ORR) was 7.3% (95% confidence interval: 1.5-19.9); no patients achieved a complete response, 3 patients (7.3%) achieved a partial response (duration of response; 3.0, 3.8, and 9.2 months, respectively), and 9 patients (22.0%) had stable disease. In total, 39 patients (95.1%) experienced a treatment-related adverse event, but no new safety issues were observed. HRQoL, assessed using FOSI, or Functional Assessment of Cancer Therapy - Ovarian Symptom Index scores, worsened over time compared with baseline scores., Conclusions: The study was terminated due to the observed ORR at the interim futility analysis. This highlights a need for effective therapies in treating patients with recurrent BRCAwt PROC., Competing Interests: Declaration of Competing Interest LMR reports personal fees from GSK/TESARO for consultancy unrelated to this study; research grant (to institution): Seagen, Genmab, Merck, Akeso, Mersana, Incyte, GOG Foundation, Genentech; consulting fees: Agenus, Akeso, AstraZeneca, Clovis Oncology, Eisai, Elevar, EMD Serono/Merck, Genmab, Seagen, GOG Foundation, Hengrui, ImmunoGen, Iovance, Merck, Mersana, Myriad, Novocure, Pfizer, Regeneron, Roche/Genentech, GSK/Tesaro, Zentalis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AstraZeneca, Eisai, Myriad, Roche/Genentech, GSK/Tesaro. DMO reports grant funding (to the institution) from AbbVie; personal fees for an advisory board from AbbVie; support for manuscript preparation from GSK/TESARO. BJM reports consulting/advisory role and honoraria for AbbVie, ChemoCare, ChemoID, Eisai, Geistlich Pharma, Incyte, Mateon Therapeutics, Merck, Myriad Pharmaceuticals, Perthera, Precision Oncology, Samumed, Takeda, and VBL Therapeutics; consulting/advisory role, honoraria, and research funding (to the institution) from Advaxis, Amgen, Immunogen, NuCana BioMed and Pfizer; consulting/advisory role, speakers bureau, honoraria, and research funding (to the institution) from AstraZeneca, Roche/Genentech and TESARO; consulting/advisory role, speakers bureau and honoraria from Clovis Oncology; speakers bureau, honoraria and research funding (to the institution) from Janssen; consulting/advisory role for Cerulean Pharma, OncoMed, and OncoSec; a leadership role for US Oncology; honoraria from Agenus, Conjupro Biotherapeutics, Genmab, Immunomedics, OncoQuest, and PumaBiotechnology; research funding (to the institution) from Array BioPharma, Lilly, Morphotek, Novartis, and Regeneron. RLC reports consulting, grant and honoraria/reimbursement from AstraZeneca, Clovis Oncology, Janssen, Merck, and Roche/Genentech; consulting and honoraria/reimbursement from Arrivive, Eisai, Novocure, Oncomed/Mateo, and TESARO/GSK; consulting and grant from AbbVie, grant from Genmab. SG reports a consulting/advisory role for AstraZeneca, Immunogen, Rigel, and Sermonix Pharmaceuticals; research funding (to the institution) from AbbVie, AstraZeneca, Genentech/Roche, Iovance Biotherapeutics, Pfizer, PharmaMar, and GSK/TESARO; hold patents, royalties or other intellectual property with Sermonix Pharmaceuticals. SA reports research funding from AstraZeneca. LRD reports consulting/advisory role for Genentech/Roche, Merck, Inovio Pharmaceuticals, CUE Biopharma; institutional research funding from GSK, Millennium, Bristol-Myers Squibb, Aeterna Zentaris, Novartis, Abbvie, GSK/TESARO, Cerulean Pharma, Aduro Biotech, Advaxis, Syndax, Pfizer, Merck, Genentech/Roche, Cerulean Pharma, Morab, Morphotek, Syndax, Ludwig Institute for Cancer Research, Leap Therapeutics. HD reports a consulting/advisory role for Eisai and Merck. RWH reports speaker's bureau from AstraZeneca, Clovis, and GSK. MH reports advisory board participation for Clovis Oncology, Janssen, Immunogen, Eisai, Seagen, and Tesaro; grant funding from Merck. HSC has nothing to disclose. NGC reports participation in advisory boards from AstraZeneca, GSK, Toray, Tarveda Therapeutics, Aadi. ACE is an employee and stockholder in Natera Inc. REO is funded in part by the NIH/NCI Cancer Center Support Grant P30 CA008748, reports personal fees for advisory boards from TESARO/GSK, Bayer, Regeneron, SeaGen, Fresenius Kabi, R-Pharm, Miltenyi, 2seventybio and Immunogen; reports personal fees from MJH Life Sciences, Onclive/PER and Curio; and reports non-compensated membership of steering committees for the PRIMA and DUO-O studies. SW reports a consulting/advisory role for Regeneron. AT, AS, LMN, AB and VS are employees of and hold stocks/shares in GSK. PAK reports personal fees from GSK/TESARO for consultancy unrelated to this study and personal fees for advisory board participation from AstraZeneca, Merck, and Pfizer., (Copyright © 2023. Published by Elsevier Inc.)