Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Predicitve patient characteristics
研究概览
简要总结
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
详细描述
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients treated with pemprolizumab
All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. Patients will be included from all 14 WIN-O (Werkgroep Immunologie Nederland voor Oncologie) centers in the Netherlands. Patients are at least 18 years of age.
干预措施: Pemprolizumab (Drug)
结局指标
主要结局
Predicitve patient characteristics
时间窗: baseline
Patient characteristics: age, gender, WHO performance status
Predictive tumor characteristics
时间窗: baseline
Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.
Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria
时间窗: 2 years
Early serum response markers
时间窗: up to day 126
Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab.
次要结局
- Survival(2 years)