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

Primary Purpose

Melanoma Stage III, Melanoma Stage IV

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beta-Glucan
Sponsored by
Kelly McMasters
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
May 10, 2023
Sponsor
Kelly McMasters
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1. Study Identification

Unique Protocol Identification Number
NCT04513028
Brief Title
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Official Title
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kelly McMasters

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma Stage III, Melanoma Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-Glucan
Intervention Description
500mg (1 capsule) by mouth twice a day for 21 days.
Primary Outcome Measure Information:
Title
Changes in percent of lymphocyte cell surface expression markers
Description
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.
Title
Changes in absolute number of lymphocyte cell surface expression markers
Description
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-glucan
Title
Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers
Description
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-glucan
Title
Changes in percent of intracellular cytokine expression markers
Description
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-glucan
Title
Changes in absolute number of intracellular cytokine expression markers
Description
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
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
Title
Changes in fluorescent intensity of intracellular cytokine expression markers
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Woeste, MD
Phone
502-852-0325
Email
matthew.woeste@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly M McMasters, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Woeste, MD
Phone
502-852-0325
Email
matthew.woeste@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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