NCT04056026已完成早期 1 期
A Single Dose FMT Infusion From a Healthy Family Donor Via Colonoscopy as an Adjunct to Keytruda for the Benefit of Improving Efficacy of Immunotherapy for Metastatic Mesothelioma
ProgenaBiome2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年9月18日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda
详细描述
Studies have shown that a favorable microbiome can be the difference between response and non-response of certain cancer treatments such as PD-1 blockade inhibitors. As such the investigators propose to ensure a favorable microbiome in this patient by fecal microbiota transplant to enhance the efficacy of such a drug, Keytruda.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy
排除标准
- •Patient unable/unwilling to comply with protocol
- •Patient deemed not a candidate for PD-1 Blockade inhibitor therapy
结局指标
主要结局
Progression free survival
时间窗: Five years
The time from transplant that the patient's tumors remain stable or shrink.
次要结局
未报告次要终点
研究者
研究点 (2)
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