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NCT Number: NCT04513028

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

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

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Key information

Conditions

Melanoma Stage III Melanoma Melanoma Stage IV Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Matthew Woeste, MD

CONTACT

[email protected]

502-852-0325

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

beta-glucan

Dietary Supplement

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

Primary outcomes

  1. Changes in percent of lymphocyte cell surface expression markers

    Time frame: 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.

    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

  2. Changes in absolute number of lymphocyte cell surface expression markers

    Time frame: Blood 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

  3. Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers

    Time frame: Blood 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

  4. Changes in percent of intracellular cytokine expression markers

    Time frame: Blood 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

  5. Changes in absolute number of intracellular cytokine expression markers

    Time frame: Blood 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

  6. Changes in fluorescent intensity of intracellular cytokine expression markers

    Time frame: Blood 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Woeste, MD

CONTACT

[email protected]

502-852-0325

Sponsors and collaborators

Lead sponsor

Kelly McMasters

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2020
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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