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

Source: MDLinx, May 2020

Researchers conducted this randomised, double-blind, placebo-controlled, phase 2 trial to test the safety and effectiveness of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy vs a placebo in patients with stage IV melanoma with no evidence of disease. This trial was conducted in 20 German academic medical centres. Eligible patients (aged 18 to 80 years) with stage IV melanoma with no evidence of disease after surgery or radiotherapy were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1–12), or double-matching placebo group.

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