NCT04513028Recruiting
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jul 2020
- Start date
- 3 Nov 2020
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Kelly McMasters
- Diseases
- Melanoma
- NCT number
- NCT04513028
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 3 Nov 2020 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving continuous or other ongoing immunosuppressive therapy
- Patients with concurrent malignancy or recent history thereof
Other illness
- 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
Other
- Patients with mucosal melanoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.