A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
研究概览
简要总结
Determine Phase 2 dose of study drug
详细描述
Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Arm 1
Temsirolimus 25 mg every 14 days + nivolumab
干预措施: Temsirolimus (Drug)
Arm 1
Temsirolimus 25 mg every 14 days + nivolumab
干预措施: nivolumab (Drug)
Arm 2
Irinotecan 150 mg/m2 every 14 days + nivolumab
干预措施: Irinotecan (Drug)
Arm 2
Irinotecan 150 mg/m2 every 14 days + nivolumab
干预措施: nivolumab (Drug)
Arm 3
Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period
干预措施: Irinotecan + capecitabine (Drug)
Arm 3
Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period
干预措施: nivolumab (Drug)
结局指标
主要结局
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.
时间窗: up to 4 weeks
phase 2 dosing of nivolumab + chemotherapy
次要结局
- Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2(12 weeks)
- Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study(up to 12 months)
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03(up to 12 months)
- The overall survival (OS) and progression-free survival (PFS)(up to 12 months)