Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Melanoma
• Intervention / Treatment: Other: Prebiotic Food-Enriched Diet

Detailed Description

Primary Objectives

• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks

Secondary Objectives

• Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)
• Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens
• Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
• Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks
• Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
• Assess the effects of dietary intervention on systemic and tumor immunity
• Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
• Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
• Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks

• Study Type: Interventional
• Enrollment (Estimated): 75
• 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
      • Principal Investigator: Erez Baruch, MD,PHD
      • 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:

• Age ≥18 years old
• English-speaking
• Body mass index (BMI) 18.5-45 kg/m2
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
• Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
• Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
• Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
• WOCP must have negative UPT within 1 week of beginning dietary intervention.
• Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
• Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.

Exclusion Criteria:

• Previous ICB treatment in the metastatic setting
• History of inflammatory bowel disease, total colectomy, or bariatric surgery.
• Currently taking steroids > Prednisone 10 mg/day or equivalent
• Medical contraindications to the Intervention Diet as determined by the treating physician.
• Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
• Insulin-dependent diabetes or condition requiring bile acid sequestrants
• Unable or unwilling to undergo study procedures.
• IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.
• Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.
• Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.
• Currently pregnant, planning to become pregnant, or lactating.
• Concurrent malignancy requiring systemic therapy other than hormonal therapy.
• 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 receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.	Other: Prebiotic Food-Enriched Diet; Given by PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.	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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 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; Melanoma
• Other Study ID Numbers: 2024-0387; NCI-2024-05150 (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
• product manufactured in and exported from the U.S.: No