Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Dose-limiting toxicity (DLT)
研究概览
简要总结
This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.
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
spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
干预措施: spartalizumab (PDR001) (Drug)
spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
干预措施: regorafenib (Drug)
结局指标
主要结局
Incidence of Dose-limiting toxicity (DLT)
时间窗: 8 Weeks
A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.
次要结局
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Up to 150 days after last administration of PDR001)
- Severity of AEs and SAEs(Up to 150 days after last administration of PDR001)