CheckMate 214 — Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Phase 3 · 2018 · Renal Cell Carcinoma

Design

Randomized trial of nivolumab plus ipilimumab vs. sunitinib in untreated advanced RCC.

Population

Previously untreated advanced/metastatic clear-cell RCC, primary analysis in IMDC intermediate/poor-risk patients.

Primary Endpoint

overall survival (OS), objective response rate (ORR), and progression-free survival (PFS) in intermediate/poor-risk

Key Result

8-year extended follow-up (99.1 mo median): intermediate/poor-risk median OS 46.7 vs 26.0 mo (HR 0.69); ORR 42.4% vs 27.5% with 11.8% vs 2.6% complete responses; ITT OS HR 0.72.

Guideline Impact

NCCN preferred first-line for intermediate/poor-risk clear-cell RCC