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

3期 进行中(已停止招募) NCT01274338

适应症Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7
分期3期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数1,673 人
干预(药物)Ipilimumab, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
开始日期2011年6月17日
完成日期2019年2月15日
结果公布日2021年5月27日

摘要

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

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

同一适应症的其他试验

全部试验

本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。