Recruiting

Beta-Glucan

Sponsor:

Kelly McMasters

Code:

NCT04513028

Conditions

Melanoma Stage III

Melanoma Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Beta-Glucan

Study Details

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

Study ID

NCT04513028

Start date

Nov 3, 2020

Status verified date

Oct, 2025

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

Beta-Glucan

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

Primary outcome measure

  • 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. ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Matthew Woeste, MD

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

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Matthew Woeste, MD

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

More Information

Sponsor

Kelly McMasters

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kelly McMasters on 2025-10-30.