Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
1期
已完成
NCT01024231
| 适应症 | Malignant Melanoma |
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| 分期 | 1期 |
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| 申办方 | Bristol-Myers Squibb |
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| 状态 | 已完成 |
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| 受试者人数 | 127 人 |
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| 干预(药物) | BMS-936558 (MDX1106-04), Ipilimumab |
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| 开始日期 | 2009年12月14日 |
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| 完成日期 | 2014年2月4日 |
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| 结果公布日 | 2021年3月22日 |
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摘要
The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)
Number of Participants With an Adverse Event (AE)
Up to 3 years · Participants
| Cohort 1 | 14 Participants |
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| Cohort 2 | 17 Participants |
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| Cohort 2a | 16 Participants |
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| Cohort 3 | 6 Participants |
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| Any BMS and Ipi Combo | 53 Participants |
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| Cohort 6 | 17 Participants |
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Number of Participants With a Serious Adverse Event (AE)
Up to 3 years · Participants
| Cohort 1 | 10 Participants |
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| Cohort 2 | 15 Participants |
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| Cohort 2a | 10 Participants |
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| Cohort 3 | 5 Participants |
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| Any BMS and Ipi Combo | 40 Participants |
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| Cohort 6 | 9 Participants |
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Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation
Up to 3 years · Participants
| Cohort 1 | 2 Participants |
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| Cohort 2 | 8 Participants |
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| Cohort 2a | 5 Participants |
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| Cohort 3 | 1 Participants |
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| Any BMS and Ipi Combo | 16 Participants |
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| Cohort 6 | 5 Participants |
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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。