Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced/Metastatic Solid Tumors Treated With Standard Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Main objective of the study
研究概览
简要总结
Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or anti-CTLA4.
To date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced/metastatic solid tumors treated with standard immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages
- •Patients who are due to start standard treatment with anti-PD1, anti-PDL1, or anti-CTLA4 (combinations of ICIs are permitted) at the Léon Bérard Center:
- •Cohort A: ICI without concomitant chemotherapy
- •Cohort B: ICI with concomitant chemotherapy
- •Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.
- •Patients affiliated with or covered by a social security system.
排除标准
- •Patients to be treated with immunotherapy in combination with targeted therapy.
- •Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy
- •Pregnant or breastfeeding patients.
- •Patients with other known cancers that are progressing or requiring the initiation of another treatment.
- •Patients with psychological, family, geographical, or social circumstances that, in the investigator's judgment, could potentially prevent the signing of an informed consent form and/or compliance with study procedures.
- •Patients in one or more of the following situations: subject to legal protection measures, deprived of liberty by judicial or administrative decision, receiving psychiatric care, admitted to a health or social care facility for purposes other than research
研究组 & 干预措施
Cohorte A: Immunothérapie sans chimiothérapie concomitante
Immunotherapy without concurrent chemotherapy
干预措施: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO (Diagnostic Test)
Cohorte B : Immunothérapie avec chimiothérapie concomitante
Immunotherapy with concurrent chemotherapy
干预措施: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO (Diagnostic Test)
结局指标
主要结局
Main objective of the study
时间窗: up to 12 months
Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy
次要结局
未报告次要终点