A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence

Trial Profile

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs Nivolumab (Primary) ; Ipilimumab
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate 238
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 30 Oct 2017 Results from this study were presented at the European Society for Medical Oncology (ESMO) 2017 Congress, as reported in a Bristol-Myers Squibb media release
    • 30 Oct 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial European Medicines Agency (EMA) validated type II variation application to expand the current indications for Opdivo (nivolumab) to include the treatment of patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
    • 16 Oct 2017 According to a Bristol-Myers Squibb media release, the US FDA has accepted, for priority review, the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The sBLA is based on data from this trial.
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