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