BENITIONSClinical Trial Intelligence

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

第3相 実施中(募集終了) NCT01274338

対象疾患Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7
第3相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数1,673 名
介入(薬剤)Ipilimumab, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
開始日2011年6月17日
完了日2019年2月15日
結果公開日2021年5月27日

概要

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

Arm B (HDI)2.5 years
Arm C (LIP)4.5 years
p-value0.065

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

Arm B (HDI)0.67 proportion of participants
Arm C (LIP)0.72 proportion of participants
p-value0.044

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

Arm A (HIP)3.9 years
Arm B (HDI)2.4 years

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