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Brief Title: Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Official Title: Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Study ID: NCT04513028
Brief Summary: The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Louisville, Louisville, Kentucky, United States
Name: Kelly M McMasters, MD
Affiliation: University of Louisville
Role: PRINCIPAL_INVESTIGATOR