To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Primary Objectives • Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks Secondary Objectives * Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance) * Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens * Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks * Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks * Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary intervention on systemic and tumor immunity * Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
Given by PO
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGEvaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
Time frame: Up to 2 years
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