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Effect of Oral Beta-Glucan with Pembrolizumab on Immune Response in Stage III-IV Melanoma Patients
Led by Kelly McMasters · Updated on 2025-10-30
30
Participants Needed
1
Research Sites
24 weeks
Total Duration
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
Research Team
M
Matthew Woeste, MD
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