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

NCT ID: NCT04513028

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2027-01-15

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.

Conditions

Melanoma Stage III; Melanoma Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Beta-Glucan

Intervention Type: DIETARY_SUPPLEMENT

500mg (1 capsule) by mouth twice a day for 21 days.

Interventions

Beta-Glucan

500mg (1 capsule) by mouth twice a day for 21 days.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kelly McMasters

OTHER

Sponsor Role: lead

Responsible Party

Kelly McMasters

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kelly M McMasters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Woeste, MD

Role: CONTACT

matthew.woeste@louisville.edu

502-852-0325

Facility Contacts

Matthew Woeste, MD

Role: primary

matthew.woeste@louisville.edu

502-852-0325

Other Identifiers

20.0614

Identifier Type: -

Identifier Source: org_study_id