RecruitingNot ApplicableNCT04513028

Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma

Sponsor

Kelly McMasters

Enrollment

30 participants

Start Date

Nov 3, 2020

Study Type

INTERVENTIONAL

Conditions

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.

Min Age: 18 Years

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
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

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

DIETARY_SUPPLEMENTBeta-Glucan

500mg (1 capsule) by mouth twice a day for 21 days.

University of Louisville

Louisville, Kentucky, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT04513028