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

Completed · Phase 3 · Has a placebo group

Conditions studied: High Risk Stage III Melanoma

In brief

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

Key facts

Study ID

NCT00636168

Run by

Bristol-Myers Squibb

People needed

1211

Starts

2008-06-30

Expected to finish

2018-11-26

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• North. Cal. Melanoma Center-St. Mary's Medical Center — San Francisco, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Boca Raton Comprehensive Cancer Center — Boca Raton, Florida, United States
• H Lee Moffitt Cancer Cnt And Res Inst — Tampa, Florida, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Nevada Cancer Center — Las Vegas, Nevada, United States
• Atlantic Melanoma Center — Morristown, New Jersey, United States
• University Of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• St Lukes Hospital And Health Network — Bethlehem, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Ctr — Nashville, Tennessee, United States
• Center For Oncology Research & Treatment, P.A. — Dallas, Texas, United States
• Huntsman Cancer Institute At The Univ. Of Utah — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Local Institution — Waratah, New South Wales, Australia
• Local Institution — Westmead, New South Wales, Australia
• Local Institution — Greenslopes, Queensland, Australia
• Local Institution — Woolloongabba, Queensland, Australia
• Local Institution — Box Hill, Victoria, Australia
• The Angeles Clinic & Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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