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Ipilimumab (10 mg/kg) (n=40) vs. ipilimumab alone (n=42)
randomized controlled trial
ipilimumab
10 mg/kg ipilimumab every 3 weeks (Q3W) × 4 induction doses
ipilimumab
3 mg/kg ipilimumab every 3 weeks (Q3W) × 4 induction doses
At Week 24 (W24), eligible patients could receive ipilimumab maintenance treatment every 12 weeks (Q12W) or enter a companion study for follow-up and/or extended therapy
mML - L2 - all population
24.4% pretreated with adjuvant and 65.9 pretreated for metastatic disease
double blind
14 sites in 7 European, North American, and South American countries
P2/ no alpha no interim analysis/ objectives did not estimate clinical benefits
PILOT STUDY : objectives did not estimate clinical benefits
Ipilimumab (10 mg/kg) (n=365) vs. ipilimumab alone (n=362)
randomized controlled trial
ipilimumab 10 mg
10 mg/kg ipilimumab was administered by intravenous infusion for 90 min every 3 weeks for four doses. Treatment was continued for a maximum of four doses
Ipilimumab 3 mg
3 mg/kg dose groups, ipilimumab was administered by intravenous infusion for 90 min every 3 weeks for four doses. Treatment was continued for a maximum of four doses
mML - L2 - all population
with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
double blind
87 centres in 21 countries worldwide
P3/ two sided test procedure with one interim analysis / hierarchy : OS then PFS, ORR, DCR
In patients with advanced melanoma, ipilimumab 10 mg/kg resulted in significantly longer overall survival than did ipilimumab 3 mg/kg
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.
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