Study of the Relationship Between the Blood Levels of Soluble PDL1 and β2-microglobulin, and the Clinical Course of a Metastatic Solid Tumor Treated With a First-line Therapeutic of Checkpoint Immune Inhibitor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- determination of soluble PDL1
研究概览
简要总结
Exploratory interventional study of prognostic serum biomarkers of cancer progression.
Study of the relationship between the blood levels of soluble PDL1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.
详细描述
Primary objective To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured at the diagnostic stage, and the clinical course of a metastatic solid tumor (non-small cell lung cancer, kidney cancer, or melanoma) treated with a 1st line therapeutic immune checkpoint inhibitor.
The secondary objectives are:
- To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during treatment, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic immune checkpoint inhibitor.
- To study the correlation between the soluble PDL1 level and the tumor PDL1 level.
- To study the correlation between the blood levels of soluble PDL1 and β2-microglobulin.
- To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during the treatment, and the tolerance of treatment with immune checkpoint inhibitor in 1st line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patient, male or female, with metastatic cancer of the non-small cell, renal or malignant melanoma type, eligible for treatment with a first-line immune checkpoint inhibitor (immunotherapy alone or in combination with another immunotherapy, chemotherapy or targeted therapy).
- •Affiliation to a Social Security organization
- •Able to give informed consent to participate in research.
排除标准
- •Pregnant women
- •Patient under guardianship, curatorship or legal protection
- •Patient unable to understand the protocol (language barrier, cognitive difficulties)
- •Patient with another active cancer
- •Patient with creatinine clearance <60 mL / min
- •Patient participating in a therapeutic clinical trial
- •Refusal of participation
结局指标
主要结局
determination of soluble PDL1
时间窗: the day of the start of immunotherapy
ng/mL
determination of soluble B2M
时间窗: the day of the start of immunotherapy
mg/L
Imaging tumor response
时间窗: 12 month after inclusion
RECIST1.1 criteria
次要结局
- progression-free survival(12 month after inclusion)
- adverse events(12 month after inclusion)
- overall survival(12 month after inclusion)
- level of tumor PDL1(CYCLE 1 DAY 1 (each cycle is 21 days))
- determination of soluble PDL1(12 month after inclusion)
- determination of soluble B2M(12 month after inclusion)