Nivolumab versus dacarbazine in Phase III trial for Melanoma - BMS
Bristol-Myers Squibb Company announced that a randomized blinded comparative Phase III study evaluating nivolumab versus dacarbazine (DTIC) (CHECKMATE 066) in patients with previously untreated BRAF wild-type advanced Melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee (DMC) showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm.
Patients in the trial will be unblinded and allowed to cross over to nivolumab. The Company will share these data with health authorities. Dacarbazine as been used as a single therapy against melanoma since 2006.
CHECKMATE -066 is a Phase III randomized, double-blind study of patients with previously untreated BRAF wild-type unresectable Stage III and IV melanoma. The trial enrolled 418 patients who were randomized to receive either nivolumab 3 mg/kg every two weeks.
See-
Nivolumab in Melanoma without BRAF Mutation November 16, 2014 | C. Robert and Others(DOI: 10.1056/NEJMoa141208.
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