Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
研究概览
简要总结
The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.
In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Age > 18 years
- •Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade
- •Signed informed consent
- •Affiliated to(or beneficiary of) the French Social Security
排除标准
- •Pregnant or breastfeeding woman or woman who does not apply effective contraception
- •Emergency
- •Vulnerable person or unable to provide informed consent
- •Emergency
- •Person unable to comply with required study follow up
- •Contraindication to the study procedure
研究组 & 干预措施
Patients treated with Immune Checkpoint Blockade
干预措施: Blood sample collection (Procedure)
Patients treated with Immune Checkpoint Blockade
干预措施: Biopsy collection (Procedure)
结局指标
主要结局
Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
时间窗: 4 months
Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor
次要结局
未报告次要终点