Immune Profiling for Cancer Immunotherapy Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Response to therapy
研究概览
简要总结
In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).
- •Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).
排除标准
- •Pregnant women/fetuses/neonates
- •Prisoners
- •Decision-impaired individuals
结局指标
主要结局
Response to therapy
时间窗: 5 years
The investigators will employ iRECIST, and outcome criteria will be clinically evaluated and include the primary endpoints of progression (non-responders) or response, with patients followed up every month for 6 months (or until death, loss to follow-up, or withdrawal of consent), judged according to the objective response rate (ORR) assessed using iRECIST.
次要结局
未报告次要终点
研究者
Brock C. Christensen
Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine
Dartmouth-Hitchcock Medical Center