pembrolizumab plus SoC (n=60) vs. placebo plus SoC (n=60)
randomized controlled trial
pembrolizumab, with dabrafenib and trametinib
pembrolizumab 2 mg/kg intravenously every 3 weeks intravenously every 3 weeks with dabrafenib and trametinib (dabrafenib 150 mg bid plus trametinib 2 mg qd)
placebo with dabrafenib and trametinib
Placebo Q3W with dabrafenib and trametinib (dabrafenib 150 mg bid plus trametinib 2 mg qd)
mML - L2 - BRAF mutant
BRAF mutation-positive and has received prior systemic therapy for metastatic or advanced melanoma. those who had received previous systemic therapy for metastatic or advanced melanoma were not eligible to participate
double blind
22 sites in seven countries (Australia, New Zealand, Canada, Denmark, Italy, Israel, and USA)
P2/ one sided test procedure without interim analysis. No statistic plan found exept for PE (P value of 0.0025 to be declared a statistically significant improvement in this small randomized trial. Therefore, the improvement in progressionfreesurvival is numerical and not statistically significant in the current clinical trial.)OR (Assuminga hazard ratio of 0.5, approximately 74 progression-free survival events were necessary to have 80% power to reject the null hypothesis at one-sided 0.025 type I error.)
triplet therapy with dabrafenib, trametinib and pembrolizumab did not meet its primary endpoint PFS compared with the doublet therapyof dabrafenib, trametinib and placebo