{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T16:08:30Z","timestamp":1790352510344,"version":"4.1.0"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T00:00:00Z","timestamp":1674000000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T00:00:00Z","timestamp":1674000000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This study was funded by Viralytics Limited, a wholly owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Cancer Res Clin Oncol"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>No standard of care therapy exists for patients with metastatic uveal melanoma who are not HLA-A2:01 positive. The phase 1b, open-label CLEVER study (NCT03408587) evaluated V937 in combination with ipilimumab in patients with uveal melanoma.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Adults with advanced uveal melanoma and liver metastases received up to 8 cycles of intravenous V937 (1\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> TCID<jats:sub>50<\/jats:sub> per infusion; infusions on days 1, 3, 5, and 8 [cycle 1], then every 3\u00a0weeks [Q3W] thereafter [cycles 2\u20138]) and 4 cycles of intravenous ipilimumab 3\u00a0mg\/kg Q3W (beginning at cycle 1\u00a0day 8). The primary endpoint was safety. Secondary endpoints included objective response rate and progression-free survival (PFS) per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Eleven patients were enrolled (median age, 65.0\u00a0years) and received a median of 6 injections of V937 and 3.5 infusions of ipilimumab. The best overall response was stable disease in 3 patients and progressive disease in 8 patients. All patients exhibited progression per irRECIST, with a 9% irPFS rate at week 26. Ten patients had treatment-related AEs, the most frequent of which were diarrhea (55%), fatigue (45%), and myalgia (36%). Two grade 3 AEs (diarrhea, <jats:italic>n<\/jats:italic>\u2009=\u20092) were considered related to ipilimumab; neither was related to V937.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Although the combination of V937 with ipilimumab had a manageable safety profile, meaningful clinical benefit was not observed in patients with uveal melanoma and liver metastases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov, NCT03408587 (January 24, 2018).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00432-022-04510-3","type":"journal-article","created":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T09:02:53Z","timestamp":1674032573000},"page":"6059-6066","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Phase 1b study of intravenous coxsackievirus A21 (V937) and ipilimumab for patients with metastatic uveal melanoma"],"prefix":"10.1007","volume":"149","clinical-trial-number":[{"clinical-trial-number":"nct03408587","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9503-2130","authenticated-orcid":false,"given":"Jose","family":"Lutzky","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan J.","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justine V.","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yixin","family":"Ren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anlong","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rizwan","family":"Haq","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,1,18]]},"reference":[{"key":"4510_CR1","doi-asserted-by":"publisher","first-page":"3344","DOI":"10.1002\/cncr.30258","volume":"122","author":"AP Algazi","year":"2016","unstructured":"Algazi AP, Tsai KK, Shoushtari AN, Munhoz RR, Eroglu Z, Piulats JM, Ott PA, Johnson DB, Hwang J, Daud AI, Sosman JA, Carvajal RD, Chmielowski B, Postow MA, Weber JS, Sullivan RJ (2016) Clinical outcomes in metastatic uveal melanoma treated with PD-1 and PD-L1 antibodies. 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Arch Virol 162:1057\u20131059. https:\/\/doi.org\/10.1007\/s00705-016-3201-4","journal-title":"Arch Virol"}],"container-title":["Journal of Cancer Research and Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00432-022-04510-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00432-022-04510-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00432-022-04510-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,7,19]],"date-time":"2023-07-19T12:13:00Z","timestamp":1689768780000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00432-022-04510-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,18]]},"references-count":38,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2023,8]]}},"alternative-id":["4510"],"URL":"https:\/\/doi.org\/10.1007\/s00432-022-04510-3","relation":{},"ISSN":["0171-5216","1432-1335"],"issn-type":[{"value":"0171-5216","type":"print"},{"value":"1432-1335","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,18]]},"assertion":[{"value":"17 October 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 November 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 January 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Jose Lutzky has served on advisory boards and\/or has been a consultant for Eisai, BMS, Iovance, and Replimune, and has received research grant support from BMS. Ryan J. Sullivan has served on advisory boards and\/or has been a consultant for BMS, Eisai, Iovance, Merck, Novartis, OncoSec, and Pfizer, and has received research grant support from Merck. Justine V. Cohen has served on advisory boards for Regeneron and Sanofi-Genzyme. Yixin Ren and Anlong Li are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholders in Merck & Co., Inc., Rahway, NJ, USA. Rizwan Haq is a consultant for Tango Therapeutics and has received research grant support from BMS and Novartis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All patients provided written informed consent to participate. The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guidelines, and all applicable local and national laws. The institutional review board at each study site approved the protocol, all protocol amendments, and informed consent forms before the study began.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}