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Study design: CheckMate 214 (ccRCC)

  • Phase 3, randomized, multicenter, open-label study in patients with advanced/metastatic ccRCC*,1
  • Primary endpoints: ORR, PFS (both per IRRC), and OS in IMDC intermediate- and poor-risk patients1
  • Secondary endpoints: ORR, PFS (both per IRRC), and OS in any-risk (ITT); safety in all treated patients1
  • Exploratory endpoints: ORR, PFS (both per IRRC), and OS in IMDC favorable-risk patients1
*As of a November 2017 protocol amendment, NIVO in combination with IPI is only approved for 1L ccRCC patients with an intermediate or poor risk profile.
Figure adapted from ClinicalTrials.gov and Albiges et al. 2020.1

1L, first-line; ccRCC, clear cell renal cell carcinoma; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IPI, ipilimumab; IRRC, independent radiology review committee; ITT, intent-to-treat; KPS, Karnofsky Performance Status; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; QxW, every x weeks; R, randomization; RCC, renal cell carcinoma; SUN, sunitinib.

1. Albiges L, et al. ESMO Open 2020;5:e001079.