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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 alone (n=137) vs. gp100 (n=136)
randomized controlled trial
ipilimumab
ipilimumab, at a dose of 3 mg per kilogram of body weight administered once every 3 weeks for four treatments.
gp100
a gp100:209- 217(210M) peptide, 1 mg injected in the right anterior thigh, and a gp100:280-288(288V) peptide, 1 mg injected in the left anterior thigh administered once every 3 weeks for four treatments.
all administered once every 3 weeks for four treatments.
mML - L2 - all population
therapeutic regimen containing one or more of the following: dacarbazine, temozolomide, fotemustine, carboplatin, or interleukin-2.
double blind
25 centers in 13 coun- tries in North America, South America, Europe, and Africa
P3/ two sided test procedure without interim analysis. Hierarchy : OS ipi gp100 vs gp100 alone than OS ipi alone vs gp100 alone
Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma.
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