A Phase 1b Trial in Stage II-III Urothelial Cancer to Explore Pre-operative Immunotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
研究概览
简要总结
This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients. This study can be adapted or expanded based on the results obtained.
详细描述
This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients.
Urothelial cancer patients will be included that are diagnosed with either:
- cT2-4aN0M0 OR
- cT1-4aN1-3M0
PD-L1 status will be determined. When PD-L1 CPS is ≥10%, patients will be treated with three cycles nivolumab 240 mg, q3wk, on day 1, 22, 43.
The primary endpoint is feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nivolumab monotherapy
Day 1: nivolumab 240 mg Day 22: nivolumab 240 mg Day 43: nivolumab 240 mg
干预措施: Nivolumab (Drug)
结局指标
主要结局
Feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
时间窗: At 12 weeks
Percentage of patients that underwent surgery within 12 weeks after study start will be assessed
次要结局
- Pathological complete response rates of nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients(At 12 weeks)
- Toxicity of pre-operative nivolumab(From first inusion untill 100 days after the last infusion with nivolumab)
- Relapse free survival and overall survival(From first infusion untill 3 years postoperative)
- Monitor peri-surgical complications(From surgery untill 90 days after surgery)
- Translational: effects of nivolumab on the tumor microenvironment(At 12 weeks)