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Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.

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Date
2017-11
ICR Author
Larkin, James
Marsden,
Author
Weber, J
Mandala, M
Del Vecchio, M
Gogas, HJ
Arance, AM
Cowey, CL
Dalle, S
Schenker, M
Chiarion-Sileni, V
Marquez-Rodas, I
Grob, J-J
Butler, MO
Middleton, MR
Maio, M
Atkinson, V
Queirolo, P
Gonzalez, R
Kudchadkar, RR
Smylie, M
Meyer, N
Mortier, L
Atkins, MB
Long, GV
Bhatia, S
Lebbé, C
Rutkowski, P
Yokota, K
Yamazaki, N
Kim, TM
de Pril, V
Sabater, J
Qureshi, A
Larkin, J
Ascierto, PA
CheckMate 238 Collaborators
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Type
Journal Article
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Abstract
Background Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma.Methods In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients). The patients were treated for a period of up to 1 year or until disease recurrence, a report of unacceptable toxic effects, or withdrawal of consent. The primary end point was recurrence-free survival in the intention-to-treat population.Results At a minimum follow-up of 18 months, the 12-month rate of recurrence-free survival was 70.5% (95% confidence interval [CI], 66.1 to 74.5) in the nivolumab group and 60.8% (95% CI, 56.0 to 65.2) in the ipilimumab group (hazard ratio for disease recurrence or death, 0.65; 97.56% CI, 0.51 to 0.83; P<0.001). Treatment-related grade 3 or 4 adverse events were reported in 14.4% of the patients in the nivolumab group and in 45.9% of those in the ipilimumab group; treatment was discontinued because of any adverse event in 9.7% and 42.6% of the patients, respectively. Two deaths (0.4%) related to toxic effects were reported in the ipilimumab group more than 100 days after treatment.Conclusions Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 238 ClinicalTrials.gov number, NCT02388906 ; Eudra-CT number, 2014-002351-26 .).
URI
https://repository.icr.ac.uk/handle/internal/1492
DOI
https://doi.org/10.1056/nejmoa1709030
Collections
  • Clinical Studies
Subject
CheckMate 238 Collaborators
Humans
Melanoma
Skin Neoplasms
Neoplasm Recurrence, Local
Antineoplastic Agents
Adjuvants, Immunologic
Antibodies, Monoclonal
Neoplasm Staging
Disease-Free Survival
Double-Blind Method
Quality of Life
Adolescent
Adult
Aged
Aged, 80 and over
Middle Aged
Female
Male
Young Adult
Ipilimumab
Nivolumab
Research team
Melanoma and Kidney Cancer
Language
eng
License start date
2017-11
Citation
The New England journal of medicine, 2017, 377 (19), pp. 1824 - 1835

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