Clinical trial · Interventional
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
NCT04513028CI-TRIAL-00096876recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beta-Glucan | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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
- interventionNames
- Dietary Supplement: Beta-Glucan
Primary outcomes (6)
- measure
- Changes in percent of lymphocyte cell surface expression markers
- timeFrame
- Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment.
- description
- The investigators will quantify percent of lymphocyte cell surface e (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry \*CyTOF) or flow cytometry
- measure
- Changes in absolute number of lymphocyte cell surface expression markers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.