Nivolumab plus ipilimumab, in contrast with ipilimumab alone, may improve overall survival of patients with previously untreated, advanced melanoma, according to a study published in The Lancet Oncology.1

Results from phase 2 and 3 trials show that the addition of nivolumab to ipilimumab significantly improves objective response rate and progression-free survival. As part of the phase 2 CheckMate 069 trial, researchers evaluated 2-year overall survival with these 2 immunotherapy regimens in this patient population.

Among the 142 patients randomly assigned to nivolumab plus ipilimumab or ipilimumab alone, 2-year overall survival was 63.8% (95% CI, 53.3-72.6) for the combination and 53.6% (95% CI, 38.1-66.8) for ipilimumab.

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Median overall survival has not yet been reached in either treatment arm.

More than half of patients who received nivolumab plus ipilimumab reported treatment-related grade 3 to 4 adverse events, in contrast with 20% of those who received ipilimumab alone; serious grade 3 to 4 treatment-related adverse events occurred in 36% and 9% of patients, respectively.

RELATED: CTA Treatment Regimen Chart for Melanoma Updated

No new types of treatment-related adverse events or treatment-related deaths were observed.

The findings suggest that patient outcomes may be improved with the therapy combination, in contrast with first-line ipilimumab alone.                     


  1. Hodi FS, Chesney J, Pavlick AC, et al. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016 Sep 8. doi: 10.1016/S1470-2045(16)30366-7 [Epub ahead of print]