Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 770
- 试验地点
- 3
- 主要终点
- Rate of objective response (complete or partial response)
研究概览
简要总结
This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.
The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.
Patients with any of the following tumor types may be enrolled in the trial:
- Non-Small Cell Lung Cancer (NSCLC),
- Head and neck cancer,
- Melanoma,
- Bladder cancer,
- Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.
For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.
All included patients will be followed-up until progression. After this date, survival data will be collected.
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
- •Age ≥18 years at the time of study entry.
- •Patient with histologically documented metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
- •Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided.
- •Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
- •Current treatment with ICB not yet started.
- •Evaluable disease (measurable as per RECIST 1.
- •ECOG Performance status 0-
- •Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
- •Patient affiliated to a Social Health Insurance in France.
排除标准
- •Patient pregnant, or breast-feeding.
- •Uveal melanoma
- •Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
- •Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
研究组 & 干预措施
Patients treated with immune checkpoint blockade
干预措施: Patients treated with immune checkpoint blockade (Other)
结局指标
主要结局
Rate of objective response (complete or partial response)
时间窗: 18 months by patient
Response will be assessed according to RECIST 1.1 / investigator judgment
次要结局
- Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03(12 months by patient)
- Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.(18 months by patient)
- Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria(18 months by patient)