34 / 39
CheckMate 214: Study design
IMDC, International Metastatic RCC Database Consortium; KPS, Karnofsky performance status; Q2W, every 2 weeks; Q3W, every 3 weeks
Treatment until
progression or
unacceptable
toxicity
•
Treatment-naïve
advanced or
metastatic clear-cell
RCC
•
Measurable disease
•
KPS ≥70%
•
Tumor tissue
available for PD-L1
testing
Treatment
Patients
Randomize 1:1
Arm A
3 mg/kg nivolumab IV +
1 mg/kg ipilimumab IV Q3W
for four doses, then
3 mg/kg nivolumab IV Q2W
Arm B
50 mg sunitinib orally once
daily for 4 weeks
(6-week cycles)
Stratified by
• IMDC prognostic score
(0 vs 1–2 vs 3–6)
•Region (US vs
Canada/Europe vs
Rest of World)