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: 19 Apr 2018

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

    • 16 Apr 2018 Based on the data from this trial, the U.S. FDA has approved Opdivo 3 mg/kg plus Yervoy 1 mg/kg (injections for IV use) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC)
    • 12 Mar 2018 Results comparing nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma, published in the New England Journal of Medicine.
    • 10 Feb 2018 Results from additional data defining benefit to risk presented at the 2018 Genitourinary Cancers Symposium
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