pembrolizumab alone (n=153) vs. Standard of Care (SoC) (n=154)
randomized controlled trial
Pembrolizumab
pembrolizumab at a dose of 200 mg every 3 weeks intravenously
chemotherapy FOLFIRI or FOLFOX plus targeted therapy
SOC (FOLFIRI or FOLFOX) with or without bevacizumab or cetuximab. All the chemotherapy regimens were repeated every 2 weeks. mFOLFOX6 (5-FU, oxaliplatin, and leucovorin)only, 41.6% received mFOLFOX6 plus bevacizumab, 3.2% received mFOLFOX6 plus cetuximab, 10.1% received FOLFIRI (5-FU, irinotecan, and leucovorin) alone, 36 received FOLFIRI plus bevacizumab, and 11 received FOLFIRI plus cetuximab.
Subjects randomized to the chemotherapy arm will have the option to crossover and receive treatment with pembrolizumab
mCRC - 1st line (L1)
open design
192 sites in 23 countries
P3/two sided and two interim analysis. hierarchical and splitting testing strategy : If PFS hypothesis is rejected, the alpha will be shifted to ORR and OS with equal split (1.25% one sided each)
this study demonstrated an improvement of PFS at the first analysis. OS results are not published yet.