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Beta-Glucan with Pembrolizumab for Stage III-IV Melanoma

This study is looking at how a dietary supplement called Beta-Glucan might affect the immune system in people with advanced melanoma (stage III or IV). You could be eligible if you have melanoma and are starting or continuing treatment with Pembrolizumab (a type of immunotherapy). The researchers want to see if adding Beta-Glucan to Pembrolizumab can improve how your immune system responds, for example, by changing certain immune cells in your blood. They will also track clinical outcomes like if your cancer comes back or how long you live. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a pilot study, meaning it's an early look at the treatment. It plans to include 30 participants.
What's involved
You would take 500mg of Beta-Glucan by mouth twice a day for 21 days. Blood samples will be taken at the beginning, after 3 weeks of Pembrolizumab, and after 3 weeks of Pembrolizumab plus Beta-Glucan.
Compensation
Not stated in the trial record.
Follow-up
Blood samples are taken at baseline, 3 weeks post Pembrolizumab, and 3 weeks post Pembrolizumab plus oral beta-glucan treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04513028

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

Recruiting
NAAges 18+InterventionalTreatment
Kelly McMasters
~30 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Beta-Glucan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in percent of lymphocyte cell surface expression markers
Measured over Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment.
+5 more outcomes measured

Conditions

Melanoma Stage III
Melanoma Stage IV

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Kelly M McMasters, MD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Matthew Woeste, MD
[email protected]
502-852-0325
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Changes in percent of lymphocyte cell surface expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment.

    The investigators will quantify percent of lymphocyte cell surface e (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry \*CyTOF) or flow cytometry

  • Changes in absolute number of lymphocyte cell surface expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

    The investigators will quantify absolute number of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry

  • Changes in the mean fluorescent intensity of lymphocyte cell surface expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

    The investigators will quantify mean fluorescent intensity of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry \*CyTOF) or flow cytometry

  • Changes in percent of intracellular cytokine expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

    The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry

  • Changes in absolute number of intracellular cytokine expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

    The investigators will quantify absolute number of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry

  • Changes in fluorescent intensity of intracellular cytokine expression markersBlood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

    The investigators will quantify fluorescent intensity of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry