BENITIONSClinical Trial Intelligence

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
分期2期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数143 人
干预(药物)Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
开始日期2015年5月13日
完成日期2025年2月15日
结果公布日2018年8月7日

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: Nivolumab24 percentage of patients with a response

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
Part B Arm II (Nivolumab, Ipilimumab3.7 months
p-value0.25

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。