KEYNOTE-240, 2020 NCT02702401
pembrolizumab alone (n=278) vs. placebo (n=135)
randomized controlled trial
pembrolizumab
200 mg of pembrolizumab intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
placebo
saline placebo intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
Both arms received BSC at the discretion of the investigator in accordance with local practices
mHCC - 2nd line (L2)
double blind
119 medical centers in 27 countries
P3/ one sided Two interim efficacy analyses and a final efficacy analysis of O. Repartition and hierarchy with OS and PFS
In this study, OS and PFS did not reach statistical significance per specified criteria.