A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- 3-month recurrence-free survival
研究概览
简要总结
Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.
详细描述
Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients ≥18 years old
- •Large volume of pleural effusion (1 liter and more), required evacuation
- •Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)
- •Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)
排除标准
- •Autoimmune disorders
- •Previous treatment for
研究组 & 干预措施
Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma
Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
干预措施: Nivolumab (Drug)
Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer
Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
干预措施: Nivolumab (Drug)
结局指标
主要结局
3-month recurrence-free survival
时间窗: 3 months
Proportion of patients who will be without signs of radiographic recurrence after 3 months
次要结局
- Rate of any grade adverse events(3 months)