18 / 64
A A
CheckMate 214
•
Treatment-naïve
advanced or
Patients
Randomize 1:1
rm
3 mg/kg nivolumab IV +
1 mg/kg ipilimumab Q3W for four
doses, then
Stratified by
•
IMDC prognostic score
metastatic clear-cell
RCC
•
Measurable disease
•
KPS ≥70%
3 mg/kg nivolumab Q2W
Arm B
0
i i ib ll
d il f
(favorable vs intermediate
vs poor risk)
•
Region (US vs Canada/
Europe vs rest of world)
•
Tumor tissue
available for PD-L1
testing
5 mg sun t n ora y once a y or 4
weeks
(6‐week cycles)
•
Co-primary endpoints: In IMDC intermediate- and poor-risk patients:
–
ORR (per independent radiology review committee, IRRC)
–
PFS (per IRRC)
–
OS
–
Alpha was 0.001 for ORR, 0.009 for PFS, and 0.04 for OS
•
Key secondary endpoints
:
ORR, PFS, OS in the intention-to-treat patients and adverse event
Motzer, SITC 2017
incidence rate in all treated patients