Improved survival with ipilimumab in patients with metastatic melanoma.

  • Hodi F
  • O'Day S
  • McDermott D
 et al. 
  • 4

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Abstract

BACKGROUND An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab--which blocks cytotoxic T-lymphocyte-associated antigen 4 to potentiate an antitumor T-cell response--administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma. METHODS A total of 676 HLA-A*0201-positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival. RESULTS The median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P

Author-supplied keywords

  • Antibodies
  • Antigens
  • CD/immunology
  • Cancer Vaccines/adverse effects/therapeutic use
  • Combined Modality Therapy
  • Double-Blind Method
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Melanoma/drug therapy/mortality/secondary/therapy
  • Middle Aged
  • Monoclonal/adverse effects/therapeutic
  • Skin Neoplasms/pathology
  • Treatment Outcome

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Authors

  • F.S. Stephen Hodi

  • Steven J O'Day

  • David F McDermott

  • Robert W Weber

  • Jeffrey A Sosman

  • John B Haanen

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