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ipilimumab plus gp100 (n=403) vs. gp100 (n=136)
randomized controlled trial
ipilimumab plus a gp100 peptide vaccine
ipilimumab, at a dose of 3 mg per kilogram of body weight, plus a gp100 peptide vaccine
gp100
gp100:209- 217(210M) peptide, 1 mg injected in the right anterior thigh, and a gp100:280-288(288V) pep- tide, 1 mg injected in the left anterior thigh.
all administered once every 3 weeks for four treatments.
mML - L2 - all population
therapeutic regimen containing one or more of the following: dacarbazine, temozolomide, fotemus- tine, carboplatin, or interleukin-2.
double blind
25 centers in 13 countries 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.
ipilimumab plus gp100 (n=403) vs. ipilimumab alone (n=137)
randomized controlled trial
ipilimumab plus gp100
ipilimumab, at a dose of 3 mg per kilogram of body weight plus gp100:209- 217(210M) peptide, 1 mg injected in the right anterior thigh, and a gp100:280-288(288V) pep- tide, 1 mg injected in the left anterior thigh.
Ipilimumab
ipilimumab, at a dose of 3 mg per kilogram of body weight
all administered once every 3 weeks for four treatments.
mML - L2 - all population
therapeutic regimen containing one or more of the following: dacarbazine, temozolomide, fotemus- tine, 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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