Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease

Source: The ASCO Post, September 2020

In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected stage IV melanoma and no evidence of disease.1 Severe treatment-related toxicity and treatment discontinuations were substantially more common with combination vs nivolumab treatment.

Study Details

In the multicenter, double-blind trial, 167 patients with no evidence of disease after surgery or radiotherapy were randomly assigned 1:1:1 between September 2015 and November 2018 to receive nivolumab at 1 mg/kg every 3 weeks plus ipilimumab at 3 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 3 mg/kg every 2 weeks (n = 56), nivolumab at 3 mg/kg every 2 weeks plus placebo (n = 59), or double placebo (n = 52).