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

Фаза 3 Идёт, набор закрыт NCT01274338

Кратко

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

Открыть в BENITIONS Открыть на ClinicalTrials.gov

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• Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, — National Cancer Institute (NCI)
• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Me — National Cancer Institute (NCI)

Все исследования