Effect of beta-glucan on immune response in advanced melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.