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

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

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Dietary supplement: Prebiotic Xnack Packouts

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

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Erez Baruch, MD,PHD; Phone Number: 713-745-5530; Email: ENBaruch@mdanderson.org,

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Erez Baruch, MD,PHD; Phone Number: 713-745-5530; Email: ENBaruch@mdanderson.org,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

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
11. Currently pregnant, planning to become pregnant, or lactating
12. Concurrent malignancy requiring systemic therapy other than hormonal therapy
13. Cognitively impaired adults

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic food-enriched diet (PreFED); Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.	Dietary supplement: Prebiotic Xnack Packouts; Prebiotic snack packouts (distributed every two weeks) and diet counseling to support increased consumption of prebiotic foods which provide dietary fiber, plant-based protein and other nutrients selectively fermented by the microbiome (e.g., pulses and legumes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completion rate, compliance and adherence.	The completion rate is defined as proportion of participants completed the intervention. Among subjects that complete the PreFED intervention, compliance is defined as the proportion (%) of prebiotic snacks consumed versus provided and proportion (%) of counselling sessions attended, while adherence is defined as the number of servings of prebiotic foods the participant consumed.	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Erez Baruch, MD,PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: 2024-0388; NCI-2024-06747 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No