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Ipilimumab (10 mg/kg) (n=511) vs. interferon alpha (n=636)
randomized controlled trial
ipilimumab 10 mg/kg
ipi3 or ipi10 was administeredintravenously every 3 weeks for 4 doses (induction),followed by the same dose every 12 weeks for up to4 additional doses (maintenance).
HDI high dose of interferon alpha
HDI was administered intravenously at 20 million units/m2 of body surface area per day, 5 days per week, for 4 weeks (induction), followed by 10 million units/m2 per day subcutaneously every other day, 3 days per week, for 48 weeks (maintenance).
mML - NA - all population
open label
United States and Canada.
P3/ one sided and four interim analysis (OS). A 2-step hierarchic approach first evaluated ipi3 versus HDI followed by ipi10 versus HDI. Because no interim analyses had been conducted before this revision, this change did not affectthe overall type I error rate of the study design. With a 1-sidedtype I error rate of 0.022 for OS and 0.003 for RFS.
Adjuvant therapy with ipi3 benefits survival versus HDI. The currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacyto HDI.
Ipilimumab (10 mg/kg) (n=475) vs. placebo (n=476)
randomized controlled trial
ipilimumab
intravenous infusions of 10 mg/kg ipilimumab every 3 weeks for four doses, then every 3 months for up to 3 years.
placebo
intravenous infusions of placebo every 3 weeks for four doses, then every 3 months for up to 3 years.
No dose reductions or modifications were made.
mML - NA - all population
patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) with adequate resection of lymph nodes (ie, the primary cutaneous melanoma must have been completely excised with adequate surgical margins)
double-blind
91 hospitals located in 19 countries
P3/ two sided test procedure without interim analysis. Hierarchical testing procedure : RFS (0.05) then final analysis OS (0.049) and MFS (0.042)
Adjuvant ipilimumab significantly improved RFS, OS and MFS for patients with completely resected high-risk stage III melanoma.
ipilimumab alone (n=523) vs. interferon alpha (n=636)
randomized controlled trial
ipilimumab 3 mg/kg
ipi3 or ipi10 was administeredintravenously every 3 weeks for 4 doses (induction),followed by the same dose every 12 weeks for up to4 additional doses (maintenance).
HDI high dose of interferon alpha
HDI was administered intravenously at 20 million units/m2 of body surface area per day, 5 days per week, for 4 weeks (induction), followed by 10 million units/m2 per day subcutaneously every other day, 3 days per week, for 48 weeks (maintenance).
mML - NA - all population
open label
United States and Canada.
P3/ one sided and four interim analysis (OS). A 2-step hierarchic approach first evaluated ipi3 versus HDI followed by ipi10 versus HDI. Because no interim analyses had been conducted before this revision, this change did not affectthe overall type I error rate of the study design. With a 1-sidedtype I error rate of 0.022 for OS and 0.003 for RFS.
Adjuvant therapy with ipi3 benefits survival versus HDI. The currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacyto HDI.
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