OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody...indicated for the treatment of:….Unresectable or metastatic melanoma:...in combination with ipilimumab in patients with BRAF V600 wild-type melanoma.

Patients were randomly assigned, in a 2:1 ratio and in a double-blinded manner, to receive both nivolumab and ipilimumab (combination group) or ipilimumab alone (ipilimumab-monotherapy group). Randomization was stratified according to BRAF mutation status (V600 wild-type vs. mutation-positive)….The rate of investigator-assessed, confirmed objective response among the patients with BRAF wild-type tumors was 61% (95% confidence interval [CI], 49 to 72) in the combination group, versus 11% (95% CI, 3 to 25) in the ipilimumab-monotherapy group (odds ratio, 12.96; 95% CI, 3.91 to 54.49; P<0.001) (Table 2). A complete response was observed in 16 patients (22%) in the combination group and no patients in the ipilimumab-monotherapy group.