Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 4
- 主要终点
- objective response rate
研究概览
简要总结
Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.
Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy
- •Performance status 0, 1 or 2 on the ECOG scale
- •Written informed consent
排除标准
- •Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- •Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
- •Active autoimmune diseases, HIV, hepatitis C or B virus
- •Patients with any medical or psychiatric condition or disease,
- •Patients under guardianship, curatorship or under the protection of justice.
研究组 & 干预措施
Biological samples
Blood samples will be realized specifically to the study at inclusion (baseline before starting anti PD1/PDL1 treatment), and then 1 month, 3 months and 12 months after initiation of anti-PD1/PDL1 treatment.
Peripheral blood mononuclear cells (PBMC) and plasma will be collected.
Available tumor tissues will be collected.
干预措施: Biological samples (Other)
Biological samples
Blood samples will be realized specifically to the study at inclusion (baseline before starting anti PD1/PDL1 treatment), and then 1 month, 3 months and 12 months after initiation of anti-PD1/PDL1 treatment.
Peripheral blood mononuclear cells (PBMC) and plasma will be collected.
Available tumor tissues will be collected.
干预措施: Anti PD1/PDL1 treatment (Drug)
结局指标
主要结局
objective response rate
时间窗: up to 12 months after the initiation of anti-PD1/PDL1 therapy
according to RECIST v1.1 criteria
anti-telomerase specific Th1 responses
时间窗: up to 12 months after the initiation of anti-PD1/PDL1 therapy
measured by ELISPOT assay
次要结局
未报告次要终点