Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in fluorescent intensity of intracellular cytokine expression markers
研究概览
简要总结
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
详细描述
This is a clinical pilot study using oral beta-glucan on patients with advanced stage III-IV melanoma without evidence of disease receiving adjuvant Pembrolizumab. The aim is to see whether beta-glucan treatment in combination with Pembrolizumab may provide augmented immunologic phenotypes such as decreased peripheral MDSCs, enhanced T effector cell function, or enhanced cytokine production in the peripheral blood or plasm of enrolled subjects. Secondary outcome measures will include clinical endpoints such as recurrence, progression free survival and overall survival.
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
- •Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).
- •Must be treatment naïve or have had treatment no less than 6 months prior to enrollment
- •18 years or older
- •Must be able to take pills
- •ECOG performance status of 0-3
- •Ability to understand and willingness to sign a written informed consent
- •Members of all racial and ethnic groups are eligible for this study
排除标准
- •History of hypersensitivity reactions attributed to beta-glucan
- •Patients receiving continuous or other ongoing immunosuppressive therapy
- •Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately
- •Patients with mucosal melanoma
- •Patients with concurrent malignancy or recent history thereof
结局指标
主要结局
Changes in fluorescent intensity of intracellular cytokine expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
The investigators will quantify fluorescent intensity of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in absolute number of lymphocyte cell surface expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
The investigators will quantify absolute number of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in absolute number of intracellular cytokine expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
The investigators will quantify absolute number of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
The investigators will quantify mean fluorescent intensity of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry \*CyTOF) or flow cytometry
Changes in percent of lymphocyte cell surface expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment.
The investigators will quantify percent of lymphocyte cell surface e (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry \*CyTOF) or flow cytometry
Changes in percent of intracellular cytokine expression markers
时间窗: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
次要结局
未报告次要终点
研究者
Kelly McMasters
Principal Investigator
University of Louisville