Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall survival (OS) at 1 year
研究概览
简要总结
This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in RIC-Mel Database:
- •Diagnosed with melanoma and cared for in the participating sites
- •Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out
- •Patients included in French nivolumab ATU program
排除标准
- •Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Overall survival (OS) at 1 year
时间窗: at 1 year
Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program
Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program
时间窗: at baseline
Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics
Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy
时间窗: at baseline
Clinical characteristics will be summarized using descriptive statistics.
Overall survival (OS) at 2 years
时间窗: at 2 years
Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program
次要结局
- Incidence of select Grade 3, 4, or 5 adverse events (AEs)(up to 2 years)
- Progression-free survival (PFS)(1 year and 2 years)
- Objective response rate (ORR)(1 year and 2 years)
- Progression-free survival (PFS) as assessed by RECIST 1.1(at 1 year)
- Distribution of treatment patterns(up to 2 years)