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nivolumab plus ipilimumab (n=-9) vs. nivolumab alone (n=-9)
randomized controlled trial
nivolumab plus ipilimumab
240 mg of nivolumab intravenously every 2 weeks and 1 mg/kg of ipilimumab every 6 weeks for up to 1 year.
nivolumab
480 mg of nivolumab every 4 weeks for up to 1 year.
mML - NA - all population
double-blind
P3/
Qualitative results realeased in BMS news in october 2020 : Statistically significant benefit was not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1% (2019 results) and in the all-comer (intent-to-treat) (2020 results).
nivolumab plus ipilimumab (n=56) vs. nivolumab alone (n=59)
randomized controlled trial
nivolumab plus ipilimumab
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
3 mg/kg of nivolumab every 2 weeks (plus ipilimumab-matching placebo during weeks 1–12
For patients with disease recurrence receiving nivolumab-matching placebo plus ipilimumabmatching placebo, crossover to nivolumab was allowed
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 )
exploratory results only
nivolumab plus ipilimumab (n=56) vs. placebo (n=52)
randomized controlled trial
nivolumab plus ipilimumab
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)
placebo
double-matching placebo group
For patients with disease recurrence receiving nivolumab-matching placebo plus ipilimumabmatching placebo, crossover to nivolumab was allowed
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
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