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

Melanoma Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513028
• Other study ID #: 20.0614
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: University of Louisville
• Contact: Matthew Woeste, MD
• Phone: 502-852-0325
• Email: matthew.woeste[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of hypersensitivity reactions attributed to beta-glucan

• Patients receiving continuous or other ongoing immunosuppressive therapy

• 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

• Patients with concurrent malignancy or recent history thereof

Related Conditions & MeSH terms

• Melanoma
• Melanoma Stage III
• Melanoma Stage IV

Intervention

Dietary Supplement:
• Beta-Glucan
500mg (1 capsule) by mouth twice a day for 21 days.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Kelly McMasters

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in percent of lymphocyte cell surface expression markers	The investigators will quantify percent of lymphocyte cell surface e (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry *CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment.
Primary	Changes in absolute number of lymphocyte cell surface expression markers	The investigators will quantify absolute number of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Primary	Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers	The investigators will quantify mean fluorescent intensity of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry *CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Primary	Changes in percent of intracellular cytokine expression markers	The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Primary	Changes in absolute number of intracellular cytokine expression markers	The investigators will quantify absolute number of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Primary	Changes in fluorescent intensity of intracellular cytokine expression markers	The investigators will quantify fluorescent intensity of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry	Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan