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NCT01274338 · ClinicalTrials.gov record · last posted 2026-08-27

Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery

StatusActive, Not Recruiting
PhasePhase 3
Started2011-06-17
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from the ClinicalTrials.gov record
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.

Protocol amendment history 1 change detected by DataLookout

2026-05-02
Completion pushed: 2026-03-19 → 2027-02-02
Trial Details
NCT Number NCT01274338
Lead Sponsor National Cancer Institute (NCI)
Conditions Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
Enrollment 1,673 participants
Start Date 2011-06-17
Primary Completion 2019-02-15 (estimated)
Study Completion 2027-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-27