Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513028
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2020-07-30
Brief Title:
Beta Glucans Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Sponsor:
Kelly McMasters
Organization:
University of Louisville
Study Overview
Official Title:
Beta Glucans Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-glucan treatment in combination with Pembrolizumab may provide augmented immunologic phenotypes such as decreased peripheral MDSCs enhanced T effector cell function or enhanced cytokine production in the peripheral blood or plasm of enrolled subjects Secondary outcome measures will include clinical endpoints such as recurrence progression free survival and overall survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None