The Phase III pivotal study that allowed FDA approval of ipilimumab to treat unresectable Stage III–IV melanoma patients was in fact designed to determine the safety and efficacy of ipilimumab in combination with BMS-734019 vaccine, a tumor-associated Ag (TAA) gp100-peptide vaccine, versus vaccine or ipilimumab alone (NCT00094653) (7). This evidence concerns the gene PMEL and melanoma.