Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
研究概览
简要总结
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
详细描述
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •metastatic renal cell carcinoma (a clear-cell/ not clear-cell)
- •Progression to previous treatment with tyrosine kinase inhibitors
- •Patients candidates for II-line therapy with Nivolumab (or tyrosine kinase inhibitors-in the control arm)
排除标准
- 未提供
结局指标
主要结局
Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
时间窗: 36 months
To investigate the predictive role of circulating miRNAs in patients who respond to nivolumab versus those who do not respond before treatment, after two infusions (4 weeks), at the first radiological re-evaluation (12 weeks) and at the time of disease progression.
Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS)
时间窗: 36 months
o characterize alterations in genes and signaling pathways and to identify mutational burden differences between tumors of patients with metastatic renal cell carcinoma who respond or not to nivolumab.
To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
时间窗: 36 months
To evaluate whether the immunological profile of tumor tissue or circulating tumor cells may be a potential predictor of clinical response in patients treated with nivolumab. Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
次要结局
未报告次要终点