Abstract | BACKGROUND: METHODS: We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus- ipilimumab group and in the nivolumab group, as compared with the ipilimumab group. RESULTS: CONCLUSIONS: Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.).
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Authors | James Larkin, Vanna Chiarion-Sileni, Rene Gonzalez, Jean-Jacques Grob, Piotr Rutkowski, Christopher D Lao, C Lance Cowey, Dirk Schadendorf, John Wagstaff, Reinhard Dummer, Pier F Ferrucci, Michael Smylie, David Hogg, Andrew Hill, Ivan Márquez-Rodas, John Haanen, Massimo Guidoboni, Michele Maio, Patrick Schöffski, Matteo S Carlino, Céleste Lebbé, Grant McArthur, Paolo A Ascierto, Gregory A Daniels, Georgina V Long, Lars Bastholt, Jasmine I Rizzo, Agnes Balogh, Andriy Moshyk, F Stephen Hodi, Jedd D Wolchok |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 381
Issue 16
Pg. 1535-1546
(10 17 2019)
ISSN: 1533-4406 [Electronic] United States |
PMID | 31562797
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2019 Massachusetts Medical Society. |
Chemical References |
- Ipilimumab
- Nivolumab
- BRAF protein, human
- Proto-Oncogene Proteins B-raf
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Follow-Up Studies
- Humans
- Ipilimumab
(administration & dosage, adverse effects)
- Melanoma
(drug therapy, genetics, mortality)
- Middle Aged
- Mutation
- Nivolumab
(administration & dosage, adverse effects)
- Proto-Oncogene Proteins B-raf
(genetics)
- Skin Neoplasms
(drug therapy, genetics, mortality)
- Survival Analysis
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