NCT04513028

Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kelly McMasters · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.

Detailed description

This is a clinical pilot study using oral beta-glucan on patients with advanced stage III-IV melanoma without evidence of disease receiving adjuvant Pembrolizumab. The aim is to see whether beta-glucan treatment in combination with Pembrolizumab may provide augmented immunologic phenotypes such as decreased peripheral MDSCs, enhanced T effector cell function, or enhanced cytokine production in the peripheral blood or plasm of enrolled subjects. Secondary outcome measures will include clinical endpoints such as recurrence, progression free survival and overall survival.

Conditions

• Melanoma Stage III
• Melanoma Stage IV

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beta-Glucan	500mg (1 capsule) by mouth twice a day for 21 days.

Timeline

• Start date: 2020-11-03
• Primary completion: 2026-07-31
• Completion: 2027-01-15
• First posted: 2020-08-14
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States