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Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Unresectable Melanoma Clinical Trial

Official title:
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Clinical Trial Summary

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting ICI therapy.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06466434
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Jennifer McQuade, MD
Phone (713) 745-9947
Email jmcquade@mdanderson.org
Status Not yet recruiting
Phase N/A
Start date December 31, 2024
Completion date June 30, 2029
View Details
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