ElevatION: CRC-101: A Phase Ib Study of PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 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 bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).
The study was terminated early due to company decision.
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
PDR001
干预措施: PDR001 (Drug)
PDR001
干预措施: bevacizumab (Drug)
PDR001
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Incidence of Dose-limiting toxicity (DLT)
时间窗: 12 months
Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
时间窗: 19 months
RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1
次要结局
- Duration of response (DOR)(Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit)
- Disease control rate (DCR)(Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit)
- Time to response (TTR)(Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit)
- Ctrough(Through end of treatment completion, an average of 14 months)
- Area under the curve (AUC)(Through end of treatment completion, an average of 14 months)
- Overall response rate (ORR) per central assessment using RECIST v1.1(Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit)
- Overall survival (OS)(Every 3 months after last visit up to 1 year after last patient last visit)
- Progression free survival(Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit)
- Cmax(Through end of treatment completion, an average of 14 months)
- Antidrug antibodies (ADA)(Through end of treatment completion, an average of 14 months)