Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKelly McMasters
About this trial
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Beta-Glucan
Dietary supplement500mg (1 capsule) by mouth twice a day for 21 days.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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.2
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
Time frame
Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan3
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
Time frame
Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan4
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
Time frame
Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucanSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kelly McMasters
Lead sponsor
University of Louisville
Sponsor institution
Source ClinicalTrials.gov