Loading clinical trials...

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

NCT06548789•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

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 RECIST1.1 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years old.
•2. Body mass index (BMI) 18.5-45 kg/m2
•3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
•4. ECOG performance status of 0 or 1
•5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
•6. Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab
•7. Measurable disease per RECIST 1.1
•8. WOCP must have negative UPT within 1 week of beginning dietary intervention.
•9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
•10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
+1 more criteria

Exclusion Criteria

•1. Uveal melanoma
•2. History of inflammatory bowel disease, total colectomy, or bariatric surgery
•3. Currently taking steroids \> prednisone 10 mg/day or equivalent
•4. Medical contraindications to the intervention diet as determined by the treating physician
•5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting
•6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants
•7. Unable or unwilling to undergo study procedures
•8. Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks
•9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study
•10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use
+3 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 16, 2024

Primary Completion Date

September 1, 2028

Completion Date

September 1, 2030

Last Updated

February 6, 2026

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Prebiotic Xnack Packouts

DIETARY_SUPPLEMENT

Contacts

Erez Baruch, MD,PHD

CONTACT

713-745-5530 ENBaruch@mdanderson.org,

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma