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

Phase 3 Active, not recruiting NCT01274338

Summary

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.

Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP])

Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years · years

5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])

Assessed every 3 months for 2 years, then every 6 months for years 3-5 · proportion of participants

Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])

Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years · years

Open in BENITIONS View on ClinicalTrials.gov

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• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Me — National Cancer Institute (NCI)

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