Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
2期
进行中(已停止招募)
NCT02314169
| 适应症 | Anal Canal Squamous Cell Carcinoma, Metastatic Anal Canal Carcinoma, Stage IV Anal Cancer AJCC v8 |
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| 分期 | 2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 | 143 人 |
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| 干预(药物) | Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab |
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| 开始日期 | 2015年5月13日 |
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| 完成日期 | 2025年2月15日 |
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| 结果公布日 | 2018年8月7日 |
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摘要
This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Overall Response Rate: Number of Participants With Response (Part A)
Up to 2 years · percentage of patients with a response
| Part A: Nivolumab | 24 percentage of patients with a response |
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Progression-free Survival (PFS) (Part B)
Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years · months
| Part B Arm I (Nivolumab) | 2.9 months |
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| Part B Arm II (Nivolumab, Ipilimumab | 3.7 months |
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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。