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Efficacy and toxicity in a real\u2010world setting may differ from clinical trials, due to more liberal eligibility criteria and less intensive monitoring. Moreover, high costs and lack of biomarkers have raised cost\u2010benefit concerns about ipilimumab in national healthcare systems and limited its use. Here, we report the prospective, interventional study, Ipi4 (NCT02068196), which aimed to investigate the toxicity and efficacy of ipilimumab in a real\u2010world population with advanced melanoma. This national, multicentre, phase IV trial included 151 patients. Patients received ipilimumab 3\u00a0mg\/kg intravenously and were followed for at least 5\u2009years or until death. Treatment interruption or cessation occurred in 38%, most frequently due to disease progression (19%). Treatment\u2010associated grade 3 to 4 toxicity was observed in 28% of patients, and immune\u2010related toxicity in 56%. The overall response rate was 9%. Median overall survival was 12.1\u00a0months (95% CI: 8.3\u201015.9); and progression\u2010free survival 2.7\u00a0months (95% CI: 2.6\u20102.8). After 5\u2009years, 20% of patients were alive. In a landmark analysis from 6 months, improved survival was associated with objective response (HR 0.16, <jats:italic>P\u2009=<\/jats:italic>\u00a0.001) and stable disease (HR 0.49, <jats:italic>P\u2009=<\/jats:italic>\u00a0.005) compared to progressive disease. Poor performance status, elevated lactate dehydrogenase and C\u2010reactive protein were identified as biomarkers. This prospective trial represents the longest reported follow\u2010up of a real\u2010world melanoma population treated with ipilimumab. Results indicate safety and efficacy comparable to phase III trials and suggest that the use of ipilimumab can be based on current cost\u2010benefit estimates.<\/jats:p>","DOI":"10.1002\/ijc.33768","type":"journal-article","created":{"date-parts":[[2021,8,27]],"date-time":"2021-08-27T17:16:45Z","timestamp":1630084605000},"page":"100-111","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Ipilimumab in a real\u2010world population: A prospective Phase <scp>IV<\/scp> trial with long\u2010term follow\u2010up"],"prefix":"10.1002","volume":"150","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0274-0953","authenticated-orcid":false,"given":"Elin","family":"Aamdal","sequence":"first","affiliation":[{"name":"Department of Oncology Oslo University Hospital  Oslo Norway"},{"name":"Institute of Clinical Medicine, Faculty of Medicine University of Oslo  Oslo Norway"},{"name":"Department of Oncology Akershus University Hospital  L\u00f8renskog Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kari D.","family":"Jacobsen","sequence":"additional","affiliation":[{"name":"Department of Oncology Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oddbj\u00f8rn","family":"Straume","sequence":"additional","affiliation":[{"name":"Department of Oncology and Medical Physics Haukeland University Hospital  Bergen Norway"},{"name":"Centre for Cancer Biomarkers, Department of Clinical Science University of Bergen  Bergen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Kersten","sequence":"additional","affiliation":[{"name":"Research Unit S\u00f8rlandet Hospital  Kristiansand Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oluf","family":"Herlofsen","sequence":"additional","affiliation":[{"name":"Department of Oncology \u00c5lesund Hospital  \u00c5lesund Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jarle","family":"Karlsen","sequence":"additional","affiliation":[{"name":"The Cancer Clinic, St. Olav's Hospital, Trondheim University Hospital  Trondheim Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israr","family":"Hussain","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Stavanger University Hospital  Stavanger Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Amundsen","sequence":"additional","affiliation":[{"name":"Department of Oncology University Hospital of North Norway  Troms\u00f8 Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Astrid","family":"Dalhaug","sequence":"additional","affiliation":[{"name":"Department of Oncology and Palliative Medicine Nordland Hospital  Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Nyakas","sequence":"additional","affiliation":[{"name":"Department of Oncology Oslo University Hospital  Oslo Norway"},{"name":"Institute of Clinical Medicine, Faculty of Medicine University of Oslo  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Schuster","sequence":"additional","affiliation":[{"name":"Department of Oncology and Medical Physics Haukeland University Hospital  Bergen Norway"},{"name":"Centre for Cancer Biomarkers, Department of Clinical Science University of Bergen  Bergen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirsten T.","family":"Hagene","sequence":"additional","affiliation":[{"name":"Department of Oncology Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kjersti","family":"Holmsen","sequence":"additional","affiliation":[{"name":"Department of 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