Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Neoadjuvant Immune Checkpoint Blockade a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma NEO-PreFED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Immune Checkpoint Blockade a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma NEO-PreFED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To Determine the feasibility compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant IpiNivo
Detailed Description:
Primary Objectives
Determine the feasibility compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy
Secondary Objectives
1 Determine the safety AEs and tolerability GSRS-IBS of the dietary intervention during the neoadjuvant phase and maintenance phases
2 Assess the rate of immune related adverse events in patients of dietary intervention ICB during neoadjuvant and maintenance phases
3 Determine the objective response rate ORR to dietary intervention ICB as determined by RECIST11 after 2 cycles of neoadjuvant ICB diet
4 Determine the pathological response rate pRR to neoadjuvant ICB dietary intervention
5 Determine the Event-free Survival EFS Relapse-free Survival RFS and Overall Survival OS to neoadjuvant ICB dietary intervention
Exploratory Objectives
1 Assess the effect of dietary intervention ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase
2 Assess the effects of dietary intervention neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase
3 Assess the effects of dietary intervention neoadjuvant ICB on systemic and tumor immunity at time of surgery
4 Assess the effects of dietary intervention neoadjuvant ICB on quality of life and other patient reported outcomes PROs during neoadjuvant and maintenance phases
Determine the feasibility compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy
Secondary Objectives
1 Determine the safety AEs and tolerability GSRS-IBS of the dietary intervention during the neoadjuvant phase and maintenance phases
2 Assess the rate of immune related adverse events in patients of dietary intervention ICB during neoadjuvant and maintenance phases
3 Determine the objective response rate ORR to dietary intervention ICB as determined by RECIST11 after 2 cycles of neoadjuvant ICB diet
4 Determine the pathological response rate pRR to neoadjuvant ICB dietary intervention
5 Determine the Event-free Survival EFS Relapse-free Survival RFS and Overall Survival OS to neoadjuvant ICB dietary intervention
Exploratory Objectives
1 Assess the effect of dietary intervention ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase
2 Assess the effects of dietary intervention neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase
3 Assess the effects of dietary intervention neoadjuvant ICB on systemic and tumor immunity at time of surgery
4 Assess the effects of dietary intervention neoadjuvant ICB on quality of life and other patient reported outcomes PROs during neoadjuvant and maintenance phases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None