nivolumab alone (n=453) vs. Ipilimumab (10 mg/kg) (n=453)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks
ipilimumab
ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks
traetment along with corresponding matching placebo
mML - NA - all population
double-blind
130 centers in 25 countries
P3/ two sided test procedure with one interim analysis. The critical hazard ratio was 0.78 with an adjusted alpha level of 0.0244 (two-sided). (no other strategy in SAP)
Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab
IMMUNED (N vs P ; all population), 2020 NCT02523313
nivolumab alone (n=59) vs. placebo (n=52)
randomized controlled trial
nivolumab
nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1–12)
placebo
double-matching placebo group
mML - NA - all population
double-blind
20 german academic medical centres
P2/ two sided and one interim analysis. Repartition alpha between two arms (0.025/arm) (nivolumab plus ipilimumab and nivolumab versus placebo) no statistical plan for the comparaison between nivolumab plus ipilimumab and nivolumab )
Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease