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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
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
pembrolizumab alone (n=514) vs. placebo (n=505)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
placebo
placebo every 3 weeks for a total of 18 doses (approximately 1 year)
patients were eligible for crossover or repeat treatment with pembrolizumab
mML - NA - all population
Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by an immunohistochemistry assay and scored on a scale of 0-5; a score >=2 (staining on . 1% of cells) was considered PD-L1 positive
double-blind
123 centers in 23 countries
P3/ one sided test procedure with one interim analysis. Hierarchy RFS (ITT then PDL1) DMFS (ITT then PDL1) AND OS (ITT then PDL1) A SUIVRE
As adjuvant therapy for high-risk stage III melanoma, pembrolizumab resulted in significantly longer RFS and DMFS than placebo and provided a sustained and clinically meaningful improvement in RFS at 5-year median follow-up
pembrolizumab alone (n=428) vs. placebo (n=425)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
placebo
placebo every 3 weeks for a total of 18 doses (approximately 1 year)
patients were eligible for crossoveror repeat treatment with pembrolizumab
mML - NA - PDL1 positive
Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by an immunohistochemistry assay and scored on a scale of 0-5; a score >=2 (staining on . 1% of cells) was considered PD-L1 positive
double-blind
123 centers in 23 countries
P3/ one sided test procedure with one interim analysis. Hierarchy RFS (ITT then PDL1) MFS (ITT then PDL1) AND OS (ITT then PDL1) A SUIVRE
As adjuvant therapy for high-risk stage III melanoma, pembrolizumab resulted in significantly longer RFS and DMFS than placebo and provided a sustained and clinically meaningful improvement in RFS at 5-year median follow-up. Same results were observed in the PDL1 positive population.
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