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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Kelly McMasters
Study ID
NCT04513028
Status
Recruiting
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Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Beta-Glucan — DIETARY_SUPPLEMENT
    500mg (1 capsule) by mouth twice a day for 21 days.

Study Details

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

Key Dates

Start date
Nov 3, 2020
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days

Primary Outcome Measure

Changes in percent of lymphocyte cell surface expression markers [ 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Matthew Woeste, MD
[email protected]
502-852-0325

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By research site
University of Louisville· Louisville, KY

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