Status:
RECRUITING
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Lead Sponsor:
Kelly McMasters
Conditions:
Melanoma Stage III
Melanoma Stage IV
Eligibility:
All Genders
18+ years
Phase:
NA
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-gluca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04513028
Start Date
November 3 2020
End Date
January 15 2027
Last Update
October 30 2025
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202