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

Last updated: October 28, 2025
Sponsor: Kelly McMasters
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

Beta-Glucan

Clinical Study ID

NCT04513028
20.0614
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patients with suspected (clinical) or definitive (tissue) diagnosis of StageIII-IV melanoma starting or continuing adjuvant Pembrolizumab without activeevidence of disease (NED).

  • Must be treatment naïve or have had treatment no less than 6 months prior toenrollment

  • 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

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, autoimmunediseases, ongoing or active infection, symptomatic congestive heart failure,unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/socialsituations that would limit compliance with study requirements

  • Any patients who have serious autoimmune toxicity during the study period, or thosewho have disease recurrence during the 6-week study period should be excluded andanalyzed separately

  • Patients with mucosal melanoma

  • Patients with concurrent malignancy or recent history thereof

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Beta-Glucan
Phase:
Study Start date:
November 03, 2020
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

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