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The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-Glucan | Dietary Supplement | 500mg (1 capsule) by mouth twice a day for 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in percent of lymphocyte cell surface expression markers | 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 | 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. |
| Changes in absolute number of lymphocyte cell surface expression markers | 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 | Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan |
| Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers | 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 | Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan |
| Changes in percent of intracellular cytokine expression markers | The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry | Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan |
| Changes in absolute number of intracellular cytokine expression markers | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Woeste, MD | Contact | 502-852-0325 | matthew.woeste@louisville.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kelly M McMasters, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan |
| Changes in fluorescent intensity of intracellular cytokine expression markers | 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 | Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |