Actively Recruiting
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Led by Kelly McMasters · Updated on 2025-10-30
30
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how beta-glucan affects the immune system in people with advanced stage III-IV melanoma who have no active disease and are receiving adjuvant Pembrolizumab. The study aims to see if adding beta-glucan to Pembrolizumab treatment can improve immune responses, such as reducing certain suppressive immune cells and boosting T cell function or cytokine production. The trial also looks at clinical outcomes like cancer recurrence and survival as secondary measures. Participants will first receive Pembrolizumab intravenously at a dose of 200 mg every three weeks for 21 days. After this, they will take beta-glucan capsules orally, 500 mg twice daily for 21 days. This pilot study involves one treatment phase with these two sequential interventions to assess their combined effect on immune markers and clinical outcomes. During the study, blood samples will be collected at three time points: before any treatment, after the 21-day Pembrolizumab treatment, and after the 21-day beta-glucan treatment. These samples will be analyzed for various immune cell markers and cytokine levels. Researchers will monitor participants for immune response changes and clinical events such as disease recurrence. The total duration of participation includes the treatment periods and follow-up assessments for immune and clinical evaluations.
CONDITIONS
Brief Title
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected or confirmed Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab with no active disease
- Treatment naive or no treatment within 6 months before enrollment
- 18 years or older
- Able to take pills
- ECOG performance status of 0-3
- Willing and able to provide written informed consent
- All racial and ethnic groups are eligible
You will not qualify if you...
- History of allergic reactions to beta-glucan
- Receiving continuous or other ongoing immunosuppressive therapy
- Uncontrolled illnesses such as autoimmune disease, active infection, heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting study compliance
- Serious autoimmune toxicity or disease recurrence during the 6-week study period
- Mucosal melanoma
- Concurrent malignancy or recent history of another cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive 21 days of Pembrolizumab followed by 21 days of oral beta-glucan capsules twice daily to study the combined immunologic effects.
3 visits for blood analysis: at baseline, after 3 weeks of Pembrolizumab, and after 3 weeks of beta-glucan treatment
Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
M
Matthew Woeste, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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