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

NCT06466434 | Recruiting Phase 2 DMC

• 2 other identifiers: 2024-0387NCI-2024-05150
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Melanoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.

  Up to 2 years

Study Arms (1)

Prebiotic food-enriched diet (PreFED)

EXPERIMENTAL

Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.

Other: Prebiotic Food-Enriched Diet

Interventions

Prebiotic Food-Enriched Diet OTHER

Given by PO

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
• 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.

You may not qualify if:

• 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

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

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: June 14, 2024
• First Posted: June 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)