Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
研究概览
简要总结
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
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
- •Confirmed SCLC with known UGT1A genotype.
- •Patients who have received at least 1 prior platinum-based chemotherapy.
- •Life expectancy of 3 months or more.
- •Measurable disease.
排除标准
- •Patients with UGT1A polymorphism.
- •Currently receiving chemotherapy.
- •Pregnant and nursing women.
研究组 & 干预措施
Nivolumab and Irinotecan
Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan)
干预措施: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] (Drug)
Nivolumab and Irinotecan
Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan)
干预措施: Irinotecan Injection [Camptosar] (Drug)
结局指标
主要结局
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
时间窗: through study completion, an average of 1 year
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
次要结局
- Progression-free survival (PFS)(through study completion, an average of 1 year)
- Overall response rate(through study completion, an average of 1 year)
- Overall survival (OS)(through study completion, an average of 1 year.)
研究者
Nagla Abdel Karim
Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program
Augusta University