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

Not Applicable

Recruiting

• Conditions: Unresectable Melanoma

• Registration Number: NCT06466434
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-20
• Study Start: 2024-09-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age ≥18 years old
• Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
• Body mass index (BMI) 18.5-45 kg/m2
• 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) in the metastatic setting (prior ICB in adjuvant setting is allowed if last exposure ≥ 6 months prior). Prior targeted therapy is also allowed.
• Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.	Up to 2 years

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States