Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK- 3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group

Trial Profile

Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK- 3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2018

At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-054
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 25 Jun 2018 According to the Merck & Co media release, U.S. Food and Drug Administration (FDA) has accepted for standard review a new Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA) with target action date of February 16, 2019.
    • 15 Apr 2018 According to a Merck AG Media Release, results are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2018 with simultaneous publication in The New England Journal of Medicine.
    • 15 Apr 2018 Primary endpoint (RFS for Participants with PD-L1-positive Tumor Expression) has been met, according to results published in the New England Journal of Medicine.
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