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Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma

Trial Status: Complete

The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma

Inclusion Criteria

  • Age ≥ 18 years
  • Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
  • Disease-free
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Randomization within 12 weeks of surgery

Exclusion Criteria

  • Prior therapy for melanoma except surgery
  • Auto-immune disease

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED

Massachusetts

Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

Principal Investigator
unknown unknown

  • Primary ID CA184-029
  • Secondary IDs NCI-2009-01391, EORTC 18071
  • Clinicaltrials.gov ID NCT00636168