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Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open\u2010label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Nineteen patients with advanced gallbladder cancer refractory to \u22651 previous therapy received nivolumab 240\u00a0mg intravenously every 2\u00a0weeks and ipilimumab 1\u00a0mg\/kg intravenously every 6\u00a0weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR]\u00a0+\u00a0partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses\u00a0+\u00a0stable disease &gt;6\u00a0months), progression\u2010free survival, overall survival, and toxicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The confirmed ORR was 16% (CR, <jats:italic>n<\/jats:italic>\u00a0=\u00a01 [5%]; PR, <jats:italic>n<\/jats:italic>\u00a0=\u00a02 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death\u2010ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8\u00a0months (range, 4\u201335.1+ months). The 6\u2010month progression\u2010free survival was 26% (95% CI, 12\u201355). The median overall survival was 7.0\u00a0months (95% CI, 3.9\u201319.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3\/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Ipilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>NCT02834013 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClincialTrials.gov\">ClincialTrials.gov<\/jats:ext-link>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Plain Language Summary<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.35243","type":"journal-article","created":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T09:59:05Z","timestamp":1707991145000},"page":"2918-2927","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["SWOG 1609 cohort 48: anti\u2013CTLA\u20104 and anti\u2013PD\u20101 for advanced gallbladder cancer"],"prefix":"10.1002","volume":"130","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8387-4840","authenticated-orcid":false,"given":"Sandip P.","family":"Patel","sequence":"first","affiliation":[{"name":"Division of Medical Oncology University of California San Diego Moores Cancer Center  La Jolla California 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