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.
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
MD Anderson Cancer Center
Houston, Texas, United States
Overall response rate
ORR is defined as the proportion of participants whose best overall response BOR is either CR or PR. Best overall response is defined as the best response designation recorded between the date of first dose and the date of first objectively documented progression or the date of subsequent therapy, whichever occurs first per RECIST v1.1.
Time frame: Up to 2 years
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