Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (EMERGE)
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Safety run-in phase: To establish a safe and tolerable dose of domatinostat in combination with avelumab for use in the main (Phase IIB efficacy) phase of the trial
研究概览
简要总结
A multicenter phase II non-randomised trial assessing the efficacy of domatinostat (4SC-202) plus avelumab in patients with GI cancer
详细描述
During this phase II non randomised trial patients with microsatellite stable colorectal or gastroesophageal cancer which has previously been treated with chemotherapy will be treated with domatinostat plus avelumab.
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
Domatinostat plus Avelumab
This is a multicentre open-label, phase II non-randomised clinical trial domatinostat plus avelumab (two separate cohorts in phase IIB part of trial).
干预措施: Domatinostat (Drug)
Domatinostat plus Avelumab
This is a multicentre open-label, phase II non-randomised clinical trial domatinostat plus avelumab (two separate cohorts in phase IIB part of trial).
干预措施: Avelumab (Drug)
结局指标
主要结局
Safety run-in phase: To establish a safe and tolerable dose of domatinostat in combination with avelumab for use in the main (Phase IIB efficacy) phase of the trial
时间窗: The DLT period is 28 days following the first treatment with domatinostat and avelumab
Progression through dosing levels will be determined by the occurrence of dose limiting toxicities in the study population.
Main Phase IIB (efficacy) phase: Objective response rate using RECIST 1.1 criteria
时间窗: 6 months
ORR defined as the proportion of patients with either CR or PR (assessed according to RECIST 1.1) by 6 months from combination treatment initiation. The best ORR will be presented as a proportion along side a 95% confidence interval
次要结局
- Number of patients with adverse events (according to NCI-CTCAE version 4) as a measure of safety and tolerability(Up to 90 days after last dose)
- Progression free survival according to RECIST 1.1(upto 2 years)
- Overall survival(upto 2 years)
- Disease control rate(At 6 and 12 months on treatment)
- Duration of objective response according to RECIST 1.1(upto 2 years)