Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT06250335
Brief 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)
Study:
NCT06250335
Study Brief:
Protocol Section:
NCT06250335