Clinical Trials /

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

NCT04513028

Description:

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

Related Conditions:
  • Melanoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20.0614
  • NCT ID: NCT04513028

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TreatmentExperimentalAll 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

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    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.
    Safety Issue:
    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

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Kelly McMasters

    Last Updated

    August 13, 2020