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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513028
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Kelly McMasters, University of Louisville

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

Condition or disease Intervention/treatment Phase
Melanoma Stage III Melanoma Stage IV Dietary Supplement: Beta-Glucan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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. ]
    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

  2. 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 ]
    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

  3. 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 ]
    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

  4. 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 ]
    The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry

  5. 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 ]
    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

  6. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513028


Contacts
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Contact: Matthew Woeste, MD 502-852-0325 matthew.woeste@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Matthew Woeste, MD    502-852-0325    matthew.woeste@louisville.edu   
Sponsors and Collaborators
Kelly McMasters
Investigators
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Principal Investigator: Kelly M McMasters, MD University of Louisville
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Responsible Party: Kelly McMasters, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT04513028    
Other Study ID Numbers: 20.0614
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas