{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T03:00:52Z","timestamp":1792206052183,"version":"4.4.0"},"reference-count":19,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2019,4,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Nivolumab 1 mg\/kg plus ipilimumab 3 mg\/kg (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb\/IV study (CheckMate 511) to determine if nivolumab 3 mg\/kg plus ipilimumab 1 mg\/kg (NIVO3+IPI1) improves the safety profile of the combination. <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> Patients (N = 360) age 18 years or older with previously untreated, unresectable stage III or IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for four doses. After 6 weeks, all patients received NIVO 480 mg once every 4 weeks until disease progression or unacceptable toxicity. The primary end point was a comparison of the incidence of treatment-related grade 3 to 5 adverse events (AEs) between groups. Secondary end points included descriptive analyses of objective response rate, progression-free survival, and overall survival. The study was not designed to formally demonstrate noninferiority of NIVO3+IPI1 to NIVO1+IPI3 for efficacy end points. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> At a minimum follow-up of 12 months, incidence of treatment-related grade 3 to 5 AEs was 34% with NIVO3+IPI1 versus 48% with NIVO1+IPI3 ( P = .006). In descriptive analyses, objective response rate was 45.6% in the NIVO3+IPI1 group and 50.6% in the NIVO1+IPI3 group, with complete responses in 15.0% and 13.5% of patients, respectively. Median progression-free survival was 9.9 months in the NIVO3+IPI1 group and 8.9 months in the NIVO1+IPI3 group. Median overall survival was not reached in either group. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> The CheckMate 511 study met its primary end point, demonstrating a significantly lower incidence of treatment-related grade 3-5 AEs with NIVO3+IPI1 versus NIVO1+IPI3. Descriptive analyses showed that there were no meaningful differences between the groups for any efficacy end point, although longer follow up may help to better characterize efficacy outcomes. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.18.01998","type":"journal-article","created":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T20:57:26Z","timestamp":1551301046000},"page":"867-875","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":362,"title":["Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb\/IV CheckMate 511 Trial"],"prefix":"10.1200","volume":"37","author":[{"given":"Celeste","family":"Lebb\u00e9","sequence":"first","affiliation":[{"name":"Saint-Louis Hospital, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale U976, Universit\u00e9 Paris Diderot, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Meyer","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paul Sabatier-Toulouse III, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale Unit\u00e9 Mixte de Recherche 1037-CRCT, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Mortier","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lille, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale U1189, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Marquez-Rodas","sequence":"additional","affiliation":[{"name":"Hospital General Universitario Gregorio Mara\u00f1\u00f3n, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Robert","sequence":"additional","affiliation":[{"name":"Gustave Roussy, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale U981, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Rutkowski","sequence":"additional","affiliation":[{"name":"Maria Sk\u0142odowska-Curie Institute\u2013Oncology Center, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander M.","family":"Menzies","sequence":"additional","affiliation":[{"name":"Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Eigentler","sequence":"additional","affiliation":[{"name":"University Hospital T\u00fcbingen, T\u00fcbingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo A.","family":"Ascierto","sequence":"additional","affiliation":[{"name":"Istituto Nazionale Tumori\u2013Istituto di Ricovero e Cura a Carattere Scientifico Fondazione G. 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