{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T18:02:20Z","timestamp":1791914540934,"version":"4.3.4"},"reference-count":38,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T00:00:00Z","timestamp":1660694400000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2022,6,15]]},"published-print":{"date-parts":[[2022,8]]},"abstract":"\n Background<\/jats:title>\n \n CheckMate 9KD (\n NCT03338790<\/jats:ext-link>\n ) is a non-randomized, multicohort, phase 2 trial of nivolumab plus other anticancer treatments for metastatic castration-resistant prostate cancer (mCRPC). We report results from cohorts A1 and A2 of CheckMate 9KD, specifically evaluating nivolumab plus rucaparib.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n CheckMate 9KD enrolled adult patients with histologically confirmed mCRPC, ongoing androgen deprivation therapy, and an Eastern Cooperative Oncology Group performance status of 0\u20131. Cohort A1 included patients with postchemotherapy mCRPC (1\u20132 prior taxane-based regimens) and \u22642 prior novel hormonal therapies (eg, abiraterone, enzalutamide, apalutamide); cohort A2 included patients with chemotherapy-na\u00efve mCRPC and prior novel hormonal therapy. Patients received nivolumab 480\u2009mg every 4 weeks plus rucaparib 600\u2009mg two times per day (nivolumab dosing \u22642 years). Coprimary endpoints were objective response rate (ORR) per Prostate Cancer Clinical Trials Working Group 3 and prostate-specific antigen response rate (PSA\n 50<\/jats:sub>\n -RR; \u226550%\u2009PSA reduction) in all-treated patients and patients with homologous recombination deficiency (HRD)-positive tumors, determined before enrollment. Secondary endpoints included radiographic progression-free survival (rPFS), overall survival (OS), and safety.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Outcomes (95% CI) among all-treated, HRD-positive, and\n BRCA1\/2<\/jats:italic>\n -positive populations for cohort A1 were confirmed ORR: 10.3% (3.9\u201321.2) (n=58), 17.2% (5.8\u201335.8) (n=29), and 33.3% (7.5\u201370.1) (n=9); confirmed PSA\n 50<\/jats:sub>\n -RR: 11.9% (5.9\u201320.8) (n=84), 18.2% (8.2\u201332.7) (n=44), and 41.7% (15.2\u201372.3) (n=12); median rPFS: 4.9 (3.7\u20135.7) (n=88), 5.8 (3.7\u20138.4) (n=45), and 5.6 (2.8\u201315.7) (n=12) months; and median OS: 13.9 (10.4\u201315.8) (n=88), 15.4 (11.4\u201318.2) (n=45), and 15.2 (3.0\u2013not estimable) (n=12) months. For cohort A2 they were confirmed ORR: 15.4% (5.9\u201330.5) (n=39), 25.0% (8.7\u201349.1) (n=20), and 33.3% (7.5\u201370.1) (n=9); confirmed PSA\n 50<\/jats:sub>\n -RR: 27.3% (17.0\u201339.6) (n=66), 41.9 (24.5\u201360.9) (n=31), and 84.6% (54.6\u201398.1) (n=13); median rPFS: 8.1 (5.6\u201310.9) (n=71), 10.9 (6.7\u201312.0) (n=34), and 10.9 (5.6\u201312.0) (n=15) months; and median OS: 20.2 (14.1\u201322.8) (n=71), 22.7 (14.1\u2013not estimable) (n=34), and 20.2 (11.1\u2013not estimable) (n=15) months. In cohorts A1 and A2, respectively, the most common any-grade and grade 3\u20134 treatment-related adverse events (TRAEs) were nausea (40.9% and 40.8%) and anemia (20.5% and 14.1%). Discontinuation rates due to TRAEs were 27.3% and 23.9%, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Nivolumab plus rucaparib is active in patients with HRD-positive postchemotherapy or chemotherapy-na\u00efve mCRPC, particularly those harboring\n BRCA1\/2<\/jats:italic>\n mutations. Safety was as expected, with no new signals identified. Whether the addition of nivolumab incrementally improves outcomes versus rucaparib alone cannot be determined from this trial.\n <\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT03338790<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/jitc-2022-004761","type":"journal-article","created":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T11:00:14Z","timestamp":1660734014000},"page":"e004761","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":64,"title":["Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct03338790","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03338790","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02975934","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6068-9474","authenticated-orcid":false,"given":"Karim","family":"Fizazi","sequence":"first","affiliation":[{"name":"Department of Cancer Medicine, Gustave Roussy, University Paris Saclay, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margitta","family":"Retz","sequence":"additional","affiliation":[{"name":"Department of Urology, Rechts der Isar Medical Center, Technical University Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel P","family":"Petrylak","sequence":"additional","affiliation":[{"name":"Smilow Cancer Center, Yale School of Medicine, New Haven, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey C","family":"Goh","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Royal Brisbane and Women\u2019s Hospital, Herston, Queensland, Australia"},{"name":"ICON Research, South Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Perez-Gracia","sequence":"additional","affiliation":[{"name":"Oncology Department, Clinica Universidad de Navarra, Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis","family":"Lacombe","sequence":"additional","affiliation":[{"name":"Department of Surgery, H\u00f4tel-Dieu de Qu\u00e9bec, CHU de Qu\u00e9bec-Universit\u00e9 Laval, Quebec City, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Zsch\u00e4bitz","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, National Center for Tumor Disease (NCT), University Hospital, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Burotto","sequence":"additional","affiliation":[{"name":"Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hakim","family":"Mahammedi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwenaelle","family":"Gravis","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Institut Paoli-Calmettes Aix-Marseille Universit\u00e9, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diogo Assed","family":"Bastos","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven L","family":"McCune","sequence":"additional","affiliation":[{"name":"Wellstar Health System Inc, Marietta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"V\u00e1zquez Lim\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Instituto Jalisciense de Cancerolog\u00eda, Hospital Civil de Guadalajara, Guadalajara, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmond M","family":"Kwan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Monash Health, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Castellano","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Fl\u00e9chon","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Centre L\u00e9on B\u00e9rard, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fred","family":"Saad","sequence":"additional","affiliation":[{"name":"Department of Urology, Centre Hospitalier de l\u2019Universit\u00e9 de Montr\u00e9al\/CHUM, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc-Oliver","family":"Grimm","sequence":"additional","affiliation":[{"name":"Department of Urology, Jena University Hospital, Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R","family":"Shaffer","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, New York Oncology Hematology, Albany, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prabhu","family":"Bhagavatheeswaran","sequence":"additional","affiliation":[{"name":"Department of Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neha P","family":"Amin","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology, Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keziban","family":"\u00dcnsal-Ka\u00e7maz","sequence":"additional","affiliation":[{"name":"Department of Translational Medicine, Bristol Myers Squibb, Princeton, New Jersey, 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Pembrolizumab (pembro) plus olaparib in patients with docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): update of KEYNOTE-365 cohort A with a minimum of 11 months of follow-up for all patients","volume":"32","author":"Yu","year":"2021","journal-title":"Ann Oncol"}],"container-title":["Journal for ImmunoTherapy of Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jitc-2022-004761","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T20:53:19Z","timestamp":1759524799000},"score":1,"resource":{"primary":{"URL":"https:\/\/jitc.bmj.com\/lookup\/doi\/10.1136\/jitc-2022-004761"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8]]},"references-count":38,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2022,8,17]]},"published-print":{"date-parts":[[2022,8]]}},"alternative-id":["10.1136\/jitc-2022-004761"],"URL":"https:\/\/doi.org\/10.1136\/jitc-2022-004761","relation":{},"ISSN":["2051-1426"],"issn-type":[{"value":"2051-1426","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8]]}}}