Recruiting
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
About this study
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
- Condition
- Melanoma Stage III, Melanoma Stage IV
- Tested
- Beta-Glucan
- Sponsor
- Kelly McMasters
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Study condition: Melanoma Stage III, Melanoma Stage IV
- 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 6
- 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
Where
1 site, 1 recruiting
University of Louisville
Louisville, Kentucky, United States
Contact
-
Matthew Woeste, MD
502-852-0325 matthew.woeste@louisville.edu
Potential match only. Final eligibility is determined by the study team.