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
KEYNOTE-002 (10 mg/kg), 2015 NCT01704287
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.