Effect of beta-glucan on immune response in advanced melanoma patients
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
This study is testing if taking beta-glucan along with Pembrolizumab can boost the immune response in patients with advanced melanoma and help them live longer without the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | Pembrolizumab |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT04513028 on ClinicalTrials.gov |
What this trial studies
This clinical pilot study investigates the impact of oral beta-glucan on the immune system of patients with advanced stage III-IV melanoma who are receiving adjuvant Pembrolizumab. The study aims to evaluate whether the combination of beta-glucan and Pembrolizumab can enhance immunologic responses, such as reducing peripheral myeloid-derived suppressor cells (MDSCs) and improving T effector cell function. Secondary outcomes will focus on clinical endpoints, including recurrence rates, progression-free survival, and overall survival among participants. The study will enroll treatment-naïve patients or those who have not received treatment in the last six months.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active disease.
Not a fit: Patients with a history of hypersensitivity to beta-glucan or those on ongoing immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve immune responses and clinical outcomes for patients with advanced melanoma.
How similar studies have performed: While the combination of beta-glucan with immunotherapy is a novel approach, similar studies have shown promise in enhancing immune responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Kelly M McMasters, MD — University of Louisville
- Study coordinator: Matthew Woeste, MD
- Email: matthew.woeste@louisville.edu
- Phone: 502-852-0325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.