NCT06250335

Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• 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 ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.

Detailed description

Primary Objectives Determining the overall response rate (ORR) to PreFED intervention + Ipi/Nivo in ICB-refractory metastatic melanoma participants. Secondary Objectives 1. Determine progression-free survival (PFS) and overall survival (OS) to PreFED + Ipi/Nivo in ICB refractory melanoma 2. Compliance and adherence to interventions 3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention 4. Assess the rate of immune related adverse events in participants on immunotherapy receiving dietary interventions 5. Assess the effects of dietary intervention on systemic and tumor immunity 6. Assess the effect of dietary intervention on gut microbiome composition and networks 7. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism 8. Assess the effects of dietary interventions on quality of life and other participant reported outcomes (PROs)

Conditions

• ICB-refractory Melanoma

Interventions

Type	Name	Description
OTHER	Prebiotic Food-Enriched Diet	Given by PO
DRUG	Ipilimumab	Given by IV
DRUG	Nivolumab	Given by IV

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-01-23
• Completion: 2029-01-23
• First posted: 2024-02-09
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study