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

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Actual Study Start Date: October 13, 2014
Actual Primary Completion Date: June 26, 2017
Estimated Study Completion Date: September 30, 2019

Arms:
- Experimental: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
- Active Comparator: Arm B: Sunitinib 50 mg