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Recruiting NCT04513028

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

No phase Interventional Melanoma Stage III Melanoma Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beta-Glucan.
Who it may be relevant to
Registry conditions: Melanoma Stage III, Melanoma Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • Changes in absolute number 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]
  • Changes in the mean fluorescent intensity 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]
  • Changes in percent of intracellular cytokine 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]
  • Changes in absolute number of intracellular cytokine 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]
  • Changes in fluorescent intensity of intracellular cytokine 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Louisville — Louisville

Identifiers

NCT: NCT04513028 · 20.0614

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗