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

Description

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

Conditions

Melanoma Stage III, Melanoma Stage IV

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Melanoma Stage III
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kelly McMasters,

Kelly M McMasters, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

2026-07-31