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

NCT04513028 | Recruiting

• 1 other identifier: 20.0614
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (6)

• Changes in percent of lymphocyte cell surface expression markers

  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

  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.

• Changes in absolute number of lymphocyte cell surface expression markers

  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

  Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

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

  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

  Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

• Changes in percent of intracellular cytokine expression markers

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

  Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

• Changes in absolute number of intracellular cytokine expression markers

  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

  Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

• Changes in fluorescent intensity of intracellular cytokine expression markers

  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

  Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days

Dietary Supplement: Beta-Glucan

Interventions

Beta-Glucan DIETARY_SUPPLEMENT

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kelly McMasters: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Kelly M McMasters, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Woeste, MD

CONTACT

502-852-0325; matthew.woeste@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 14, 2020
• Study Start: November 3, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)