Clinical trial NCT04513028: 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
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma Stage III
Melanoma Stage IV
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in percent of lymphocyte cell surface expression markers
timeFrame: 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.
measure: Changes in absolute number of lymphocyte cell surface expression markers
timeFrame: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
measure: Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers
timeFrame: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
measure: Changes in percent of intracellular cytokine expression markers
timeFrame: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
measure: Changes in absolute number of intracellular cytokine expression markers
timeFrame: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
measure: Changes in fluorescent intensity of intracellular cytokine expression markers
timeFrame: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Kelly M McMasters, MD
role: PRINCIPAL_INVESTIGATOR
References: