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

Trial Profile

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2017

At a glance

  • Drugs Ipilimumab (Primary) ; Nivolumab (Primary) ; Sunitinib
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate 214
  • Sponsors Bristol-Myers Squibb; Ono Pharmaceutical
  • Most Recent Events

    • 28 Nov 2017 According to a Bristol-Myers Squibb media release, Company announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). Validation of the application confirms the submission is complete and begins the EMAs centralized review process.
    • 07 Nov 2017 According to a Bristol-Myers Squibb media release, results from a new exploratory analysis of this trial will be presented at the Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting.
    • 10 Sep 2017 Results published in a Bristol-Myers Squibb media release.
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