Tests beta-glucan's effect on the immune system in melanoma patients
Tests whether beta-glucan affects the immune system in adults with melanoma.
Key facts
- Who runs it
- Kelly McMasters
- Where
- Louisville, United StatesSee the site
- Trial code
- Registry title
- Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 3 Nov 2020
- Expected to end
- 15 Jan 2027
- Type of study
- Interventional
- Treatments tested
- Beta-Glucan
- Record updated
- 30 October 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage III-IV melanoma who are starting or continuing adjuvant Pembrolizumab with no sign of active disease.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Stage III-IV melanoma (suspected or confirmed) with no active evidence of disease, starting or continuing adjuvant Pembrolizumab
- Earlier treatment
- Must have had no treatment before, or treatment no less than 6 months before enrolment
Main reasons for not taking part
- Past allergic reaction to beta-glucan
- Ongoing immunosuppressive treatment
- Uncontrolled other illness, such as autoimmune disease, active infection, heart problems or psychiatric illness
- Mucosal melanoma
- Another cancer now or in the recent past
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients receiving continuous or other ongoing immunosuppressive therapy
- Patients with concurrent malignancy or recent history thereof
- History of hypersensitivity reactions attributed to beta-glucan
- 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
Where in United States
- University of LouisvilleLouisville, United StatesContact: Matthew Woeste, MDTaking people
About the trial
What the trial wants to find out
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
The group in the trial
- TreatmentTreatment being tested
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
Treatment: Beta-Glucan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
- Plain-language title
- Tests beta-glucan's effect on the immune system in melanoma patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 October 2025