•OS rate, defined as the proportion of patients alive after 2 years of follow-up time [ Time Frame: 2 years ] [ Designated as safety issue: No ] Will be estimated and compared between the two arms using the Fisher's exact test based on two-sided overall type I error rate of 0.05 adjusting for two-interim analysis. Distribution will be estimated using the Kaplan-Meier method.
Clinical Trial Information
Trial Contact: Frankos, Marie; Ford, Elizabeth
Age Group: Adult
Phase: Drug: Phase III
Principal Investigator: Sajeve Samuel Thomas, MD
Secondary Protocol No: NONE
Applicable Disease Sites: Melanoma