Melanoma Clinical Trial
Beta Glucan’s Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Summary
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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