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

NCT06548789 | Recruiting Phase 2

• 2 other identifiers: 2024-0388NCI-2024-06747
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Prebiotic food-enriched diet (PreFED)

EXPERIMENTAL

Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.

Dietary Supplement: Prebiotic Xnack Packouts

Interventions

Prebiotic Xnack Packouts DIETARY_SUPPLEMENT

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).

Prebiotic food-enriched diet (PreFED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Body mass index (BMI) 18.5-45 kg/m2
• Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
• ECOG performance status of 0 or 1
• Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
• Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab
• Measurable disease per RECIST 1.1
• 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.
• Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

You may not qualify if:

• Uveal melanoma
• 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 conditions requiring bile-acid sequestrants
• Unable or unwilling to undergo study procedures
• Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erez Baruch, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Baruch, MD,PHD

CONTACT

713-745-5530; ENBaruch@mdanderson.org,

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)