NCT06466434

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 immune checkpoint blockade (ICB) therapy.

Detailed 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

Conditions

• Unresectable Melanoma

Interventions

Type	Name	Description
OTHER	Prebiotic Food-Enriched Diet	Given by PO

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-06-30
• Completion: 2029-06-30
• First posted: 2024-06-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States