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 |
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| 分期 | 3期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 1,673 人 |
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| 干预(药物) | Ipilimumab, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b |
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| 开始日期 | 2011年6月17日 |
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| 完成日期 | 2019年2月15日 |
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| 结果公布日 | 2021年5月27日 |
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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 |
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| Arm C (LIP) | 4.5 years |
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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 |
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| Arm C (LIP) | 0.72 proportion of participants |
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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 |
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| Arm B (HDI) | 2.4 years |
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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。