A Prospective Study of the Relevance of the HLA-G Immune Checkpoint in Cancer Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 281
- 主要终点
- Objective tumor response rate
研究概览
简要总结
Therapeutic targeting of immune checkpoints PD-1/PD-L1 and/or CTLA-4 is efficient in several solid cancer subtypes, however only some patients do experience clinical benefit from these treatments. One explanation could be that multiple redundant checkpoints are present within the tumor, simultaneously keeping in check the patient's immune response. The immune checkpoint HLA-G is neo-expressed in over 50% of cases in some cancer subtypes and associated with more dismal prognosis. The immunosuppressive effects of HLA-G may result in resistance to current immunotherapy drugs.
The GEIA study explores the impact of HLA-G tumor expression on the efficacy of cancer immunotherapy in solid cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 or older
- •Social insurance
- •Ability to provide signed consent
- •Histologically proven solid cancer (non-small cell lung cancer, urothelial carcinoma, renal cell carcinoma, other)
- •Advanced and/or metastatic disease not accessible to local treatment
- •At least one target lesion according to iRECIST
- •Available fixed tumor sample for immunohistochemistry studies
- •Treatment with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy
排除标准
- •Women pregnant or breastfeeding
- •Inability to consent to this research
- •Previous cancer immunotherapy (except BCG instillations for non-muscle infiltrative bladder cancer)
- •Patients chronically infected with HIV, HBV or HCV
结局指标
主要结局
Objective tumor response rate
时间窗: at 6 months
The impact of HLA-G tumor expression (evaluated by immunohistochemistry) on tumor response rates (evaluated with iRECIST) in solid cancer patients treated with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy.
次要结局
- Progression free-survival(at 2 years)
- Overall survival(at 2 years)
- Soluble HLA-G levels counts(Up to 24 months)
- Specific disease survival(at 2 years)
- Incidence of adverse events(at 2 years)