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dc.contributor.authorWolchok, JDen_US
dc.contributor.authorChiarion-Sileni, Ven_US
dc.contributor.authorGonzalez, Ren_US
dc.contributor.authorRutkowski, Pen_US
dc.contributor.authorGrob, J-Jen_US
dc.contributor.authorCowey, CLen_US
dc.contributor.authorLao, CDen_US
dc.contributor.authorWagstaff, Jen_US
dc.contributor.authorSchadendorf, Den_US
dc.contributor.authorFerrucci, PFen_US
dc.contributor.authorSmylie, Men_US
dc.contributor.authorDummer, Ren_US
dc.contributor.authorHill, Aen_US
dc.contributor.authorHogg, Den_US
dc.contributor.authorHaanen, Jen_US
dc.contributor.authorCarlino, MSen_US
dc.contributor.authorBechter, Oen_US
dc.contributor.authorMaio, Men_US
dc.contributor.authorMarquez-Rodas, Ien_US
dc.contributor.authorGuidoboni, Men_US
dc.contributor.authorMcArthur, Gen_US
dc.contributor.authorLebbé, Cen_US
dc.contributor.authorAscierto, PAen_US
dc.contributor.authorLong, GVen_US
dc.contributor.authorCebon, Jen_US
dc.contributor.authorSosman, Jen_US
dc.contributor.authorPostow, MAen_US
dc.contributor.authorCallahan, MKen_US
dc.contributor.authorWalker, Den_US
dc.contributor.authorRollin, Len_US
dc.contributor.authorBhore, Ren_US
dc.contributor.authorHodi, FSen_US
dc.contributor.authorLarkin, Jen_US
dc.coverage.spatialUnited Statesen_US
dc.date.accessioned2018-03-02T12:58:28Z
dc.date.issued2017-10-05en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28889792en_US
dc.identifier.citationN Engl J Med, 2017, 377 (14), pp. 1345 - 1356en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1496
dc.identifier.eissn1533-4406en_US
dc.identifier.doi10.1056/NEJMoa1709684en_US
dc.description.abstractBACKGROUND: Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial. METHODS: We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent. Randomization was stratified according to programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group versus the ipilimumab group. RESULTS: At a minimum follow-up of 36 months, the median overall survival had not been reached in the nivolumab-plus-ipilimumab group and was 37.6 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio for death with nivolumab vs. ipilimumab, 0.65 [P<0.001]). The overall survival rate at 3 years was 58% in the nivolumab-plus-ipilimumab group and 52% in the nivolumab group, as compared with 34% in the ipilimumab group. The safety profile was unchanged from the initial report. Treatment-related adverse events of grade 3 or 4 occurred in 59% of the patients in the nivolumab-plus-ipilimumab group, in 21% of those in the nivolumab group, and in 28% of those in the ipilimumab group. CONCLUSIONS: Among patients with advanced melanoma, significantly longer overall survival occurred with combination therapy with nivolumab plus ipilimumab or with nivolumab alone than with ipilimumab alone. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505 .).en_US
dc.format.extent1345 - 1356en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAntibodies, Monoclonalen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectDouble-Blind Methoden_US
dc.subjectHumansen_US
dc.subjectIpilimumaben_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectMelanomaen_US
dc.subjectMiddle Ageden_US
dc.subjectNeoplasm Stagingen_US
dc.subjectNivolumaben_US
dc.subjectSkin Neoplasmsen_US
dc.subjectSurvival Rateen_US
dc.titleOverall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.en_US
dc.typeJournal Article
rioxxterms.versionofrecord10.1056/NEJMoa1709684en_US
rioxxterms.licenseref.startdate2017-10-05en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfN Engl J Meden_US
pubs.issue14en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume377en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen_US
dc.contributor.icrauthorMarsden,en_US


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