pembrolizumab plus SoC (n=16) vs. Standard of Care (SoC) (n=19)
randomized controlled trial
pembrolizumab plus chemotherapy
pembrolizumab as neoadjuvant
chemotherapy
all patients received adjuvant chemotherapy
glioblastoma (GB)
open label
PILOT STUDY : objectives did not estimate clinical benefits
Checkmate 143, 2020 NCT02017717
nivolumab alone (n=184) vs. bevacizumab (n=185)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg of nivolumab intravenously every 2 weeks.
bevacizumab
bevacizumab 10 mg/kg of bevacizumab intravenously every 2 weeks.
Dose reductions or dose escalations are not permitted.
metastatic glioblastoma (mGB) - 1st line (L1)
open label
57 multicenter, multinational clinical sites.
P3/ two sided and no interim analysis. Secondary endpoints will be tested using a hierarchical testing procedure in order to control a family-wise type I error of 0.05 (OS 12mo then PFS then ORR)
the primary end point OS was not met in this randomized clinical trial with patient with recurrent glioblastoma