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pembrolizumab (10mg/kg) (n=277) vs. ipilimumab alone (n=278)
randomized controlled trial
pembrolizumab every 3 wk
pembrolizumab at a dose of 10 mg per kilogram of body weight every 3 weeks
ipilimumab
ipilimumab at a dose of 3 mg per kilogram every 3 weeks.
Although crossover was not allowed per protocol, after the second interim analysis, an external data monitoring committee recommended making pembrolizumab available to patients in KEYNOTE-006
mML - L2 - all population
Known BRAF V600 mutational status was required. Excluded from the study were patients with ocular melanoma, active brain metastases, or a history of serious autoimmune disease.
open label
16 countries
P3/ one sided test procedure with two interim analysis. 3 arms pembrolizumab 2 weeks or 3 weeks versus ipilimumab - Subgroup BRAFV600E/K status (mutant previously treated) repartition between coprimary endpoint PFS OS
Substantiating the results of the interim analyses of KEYNOTE-006, pembrolizumab continued to provide significantly superior overall survival and progression free survival versus ipilimumab, with no difference between pembrolizumab dosing schedules
pembrolizumab (10mg/kg) (n=181) vs. Standard of Care (SoC) (n=179)
randomized controlled trial
pembrolizumab
pembrolizumab 10 mg/kg given intravenously every 3 weeks
ICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)
(paclitaxel plus carboplatin (23.4%), paclitaxel (15.6%), carboplatin (7.2%) [eliminated with protocol amendment one], dacarbazine (25.1%) , or oral temozolomide (24.0%))
the patient could cross over (48%) to receive pembrolizumab after a washout period
mML - L2 - all population
We excluded patients with known active brain metastases.
open label
73 hospitals, clinics, and academic medical centres in 12 countries
P2/ one sided test procedure with two interim analysis. 3 arms pembrolizumab 2mg/kg, 10mg/kg vs chemotherapy. repartition PFS (0.0025/arm) and OS (0.01/arm) in one-sided
Improvement in OS with pembrolizumab was not statistically significant at either dose versus chemotherapy.
pembrolizumab (10mg/kg) 2 weeks (n=279) vs. ipilimumab alone (n=278)
randomized controlled trial
pembrolizumab every 2 wk
pembrolizumab at a dose of 10 mg per kilogram of body weight every 2 weeks
ipilimumab
ipilimumab at a dose of 3 mg per kilogram every 3 weeks.
Although crossover was not allowed per protocol, after the second interim analysis, an external data monitoring committee recommended making pembrolizumab available to patients in KEYNOTE-006
mML - L2 - all population
Known BRAF V600 mutational status was required. Excluded from the study were patients with ocular melanoma, active brain metastases, or a history of serious autoimmune disease.
open label
16 countries
P3/ one sided test procedure with two interim analysis. 3 arms pembrolizumab 2 weeks or 3 weeks versus ipilimumab - Subgroup BRAFV600E/K status (mutant previously treated) repartition between coprimary endpoint PFS OS
Substantiating the results of the interim analyses of KEYNOTE-006, pembrolizumab continued to provide significantly superior overall survival and progression free survival versus ipilimumab, with no difference between pembrolizumab dosing schedules
pembrolizumab (2mg/kg) (n=180) vs. Standard of Care (SoC) (n=179)
randomized controlled trial
pembrolizumab
pembrolizumab 2 mg/kg given intravenously every 3 weeks
ICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)
(paclitaxel plus carboplatin (23.4%), paclitaxel (15.6%), carboplatin (7.2%) [eliminated with protocol amendment one], dacarbazine (25.1%) , or oral temozolomide (24.0%))
A designated pharmacist at each site who was unmasked prepared the pembrolizumab dose so that it could be administered to the patient in a masked fashionthey could cross over to receive pembrolizumab after a washout period
mML - L2 - all population
Randomisation was stratifi ed by ECOG performance status (0 vs 1), lactate dehydrogenaseconcentration, and BRAF status
open label
73 hospitals, clinics, and academic medical centres in 12 countries
P2/ one sided test procedure with two interim analysis. 3 arms pembrolizumab 2mg/kg, 10mg/kg vs chemotherapy. repartition PFS (0.0025/arm) and OS (0.01/arm) in one-sided
Improvement in OS with pembrolizumab was not statistically significant at either dose versus chemotherapy.
pembrolizumab alone (n=514) vs. placebo (n=505)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
placebo
placebo every 3 weeks for a total of 18 doses (approximately 1 year)
patients were eligible for crossover or repeat treatment with pembrolizumab
mML - NA - all population
Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by an immunohistochemistry assay and scored on a scale of 0-5; a score >=2 (staining on . 1% of cells) was considered PD-L1 positive
double-blind
123 centers in 23 countries
P3/ one sided test procedure with one interim analysis. Hierarchy RFS (ITT then PDL1) DMFS (ITT then PDL1) AND OS (ITT then PDL1) A SUIVRE
As adjuvant therapy for high-risk stage III melanoma, pembrolizumab resulted in significantly longer RFS and DMFS than placebo and provided a sustained and clinically meaningful improvement in RFS at 5-year median follow-up
pembrolizumab alone (n=428) vs. placebo (n=425)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
placebo
placebo every 3 weeks for a total of 18 doses (approximately 1 year)
patients were eligible for crossoveror repeat treatment with pembrolizumab
mML - NA - PDL1 positive
Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by an immunohistochemistry assay and scored on a scale of 0-5; a score >=2 (staining on . 1% of cells) was considered PD-L1 positive
double-blind
123 centers in 23 countries
P3/ one sided test procedure with one interim analysis. Hierarchy RFS (ITT then PDL1) MFS (ITT then PDL1) AND OS (ITT then PDL1) A SUIVRE
As adjuvant therapy for high-risk stage III melanoma, pembrolizumab resulted in significantly longer RFS and DMFS than placebo and provided a sustained and clinically meaningful improvement in RFS at 5-year median follow-up. Same results were observed in the PDL1 positive population.
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