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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=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 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.
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.
ipilimumab plus SoC (n=250) vs. placebo plus SoC (n=252)
randomized controlled trial
ipilimumab plus dacarbazine
ipilimumab plus dacarbazine (10 mg per kilogram plus 850 mg per square meter of body-surface area) given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeksthrough week 22.
dacarbazine plus placebo
dacarbazine (850 mg per square meter) plus placebo given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22.
No cross over, they were eligible to enter a maintenance phase in which they received placebo or ipilimumab every 12 weeks.
mML - L2 - all population
patients were ineligible if they had evidence of brain metastasis (as confirmed on imaging), primary ocular or mucosal melanoma, or autoimmune disease
double-blind
multinational
P3/ two sided test procedure without interim analysis. A hierarchical testing procedure was implemented in the order of the following end points: overall survival, progression- free survival, rate of disease control, and rate of best overall response
Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, ascompared with dacarbazine plus placebo, improved overall survival in patients withpreviously untreated metastatic melanoma.
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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