Page 17 - Flipbook

CheckMate -214: Nivolumab Plus Ipilimumab

in Newly Diagnosed Advanced Clear-Cell RCC

Nivolumab 3 mg/kg IV every

Key eligibility criteria Stratification 3 wk + ipilimumab 1 mg/kg IV
every 3 wk x 4 doses, then
• Treatment naïve, • IMDC prognostic N = 1,096 nivolumab 3 mg/kg every 2 wk

inoperable, locally score (0 vs 1-2 vs 3-6)
advanced, or R

metastatic RCC • Region
(United States vs 1:1
• Clear-cell histology a Canada/Europe vs Sunitinib 50 mg orally daily

• KPS ≥70% rest of the world) (4 wk on, 2 wk off)

Endpoints

• Coprimary: PFS, OS, ORR (intermediate/poor risk)

• Secondary: PFS, OS, ORR (ITT)

• Exploratory: PFS, OS, ORR (favorable risk)

Motzer RJ et al. Lancet Oncol. 2019;20:1370-1385.