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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, Jr., Pere

N Engl J Med 2011; 364:2517-2526

Conclusions

Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, as compared with dacarbazine plus placebo, improved overall survival in patients with previously untreated metastatic melanoma. The types of adverse events were consistent with those seen in prior studies of ipilimumab; however, the rates of elevated liver-function values were higher and the rates of gastrointestinal events were lower than expected on the basis of prior studies. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number