Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial

In this study (n=167), recurrence-free survival was prolonged in those receiving adjuvant nivolumab alone (12.4 months) or in combination with ipilimumab (not reached) versus placebo (6.4 months) (HR vs placebo of 0.56 [0.33-0.94; p=0.011] and 0.23 [97.5% CI 0.12-0.45; p<0.0001])

SPS commentary:

A related comment notes that a planned exploratory analysis favoured the combination group over nivolumab monotherapy for the primary endpoint of relapse-free survival (HR 0.40; 97.5% CI 0.20-0.79); the study was not however powered for this comparison. In addition there was more toxicity associated with the combination (grade 3–4 adverse events reported in 71% of the combination group versus 27% in the nivolumab group). Overall survival data are not yet available.


The Lancet

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