Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.
Collection of standard data prospectively.
详细描述
Nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. Huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. Like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist.
The aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab
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
- •Patient with squamous or non squamous non small cell lung cancer stage IV or patient with renal cell carcinoma stage IV
- •Patient receiving nivolumab or who will receive nivolumab
- •Age ⩾ 18 years old
- •OMS stage ≤ 2
- •Evaluable disease
排除标准
- •Active brain metastasis not treated before by surgery or radiotherapy
- •Autoimmune disease
- •Patient having objected to the processing of his data
结局指标
主要结局
Progression free survival
时间窗: Up to one year
Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression
次要结局
- Overall survival(Up to one year)
- Side effects(14 days)
- Nivolumab PK parameters : distribution volume(Baseline up to one year)
- Target concentration(14 days)
- Nivolumab PK parameters : clearance(Baseline up to one year)