Ipilimumab plus dacarbazine for previously untreated metastatic melanoma

Caroline Robert, Luc Thomas, Igor Bondarenko, Steven O'Day, Jeffrey Weber, Claus Garbe, Celeste Lebbe, Jean François Baurain, Alessandro Testori, Jean Jacques Grob, Neville Davidson, Jon Richards, Michele Maio, Axel Hauschild, Wilson H. Miller, Pere Gascon, Michal Lotem, Kaan Harmankaya, Ramy Ibrahim, Stephen FrancisTai Tsang Chen, Rachel Humphrey, Axel Hoos, Jedd D. Wolchok

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Ipilimumab monotherapy (at a dose of 3 mg per kilogram of body weight), as compared with glycoprotein 100, improved overall survival in a phase 3 study involving patients with previously treated metastatic melanoma. We conducted a phase 3 study of ipilimumab (10 mg per kilogram) plus dacarbazine in patients with previously untreated metastatic melanoma. METHODS: We randomly assigned 502 patients with previously untreated metastatic melanoma, in a 1:1 ratio, to ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area) or dacarbazine (850 mg per square meter) plus placebo, given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22. Patients with stable disease or an objective response and no doselimiting toxic effects received ipilimumab or placebo every 12 weeks thereafter as maintenance therapy. The primary end point was overall survival. RESULTS: Overall survival was significantly longer in the group receiving ipilimumab plus dacarbazine than in the group receiving dacarbazine plus placebo (11.2 months vs. 9.1 months, with higher survival rates in the ipilimumab-dacarbazine group at 1 year (47.3% vs. 36.3%), 2 years (28.5% vs. 17.9%), and 3 years (20.8% vs. 12.2%) (hazard ratio for death, 0.72; P

Original languageEnglish
Pages (from-to)2517-2526
Number of pages10
JournalNew England Journal of Medicine
Volume364
Issue number26
DOIs
Publication statusPublished - Jun 30 2011

ASJC Scopus subject areas

  • Medicine(all)

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