Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
研究概览
简要总结
This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.
详细描述
Tumor and blood samples will be collected on patients treated by anti-PD1 immunotherapy at different timepoints. Tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. Blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease
- •Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia
- •Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations
- •Performance status 0, 1 or 2
- •At least one measurable lesion on RECIST V1.1 criteria
排除标准
- •Head and neck squamous cell carcinoma accessible to a local treatment
- •Cancer of nasopharynx, sinus or nasal cavity
- •Other histology than epidermoid
- •Patients with contraindication for anti-PD1 immunotherapy
研究组 & 干预措施
Recurrent and/or metastatic head and neck carcinoma
Patients with indication of anti-PD1 immunotherapy according to recommendations
干预措施: Immunotherapy (Drug)
结局指标
主要结局
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
时间窗: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)
次要结局
- Exploratory outcome : investigation of the expression of other molecular signatures such as immune cells panel within the tumor microenvironment to predict anti-PD1 immunotherapy response.(at 3 months after initiation of immunotherapy)
- Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response.(at 3 months after initiation of immunotherapy)
- Prospective validation of the expression of interferon-gamma signature to predict progression free survival.(at 3 years after inclusion)
- Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response.(at 3 months after initiation of immunotherapy)
- Prospective validation of the expression of interferon-gamma signature to predict overall survival.(at 3 years after inclusion)
- Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.(at 3 years after inclusion)
- Exploratory outcome : investigation of the expression of other molecular signatures such as biomarkers expression level involved in immunogenic cell death and in mitophagy to predict anti-PD1 immunotherapy response.(at 3 months after initiation of immunotherapy)