🏛️ Verified NIH Record • Updated 2026-02-04
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED (NCT06548789)
🟢 Recruiting Phase2 📋 Clinical Research Protocol Sponsor: M.D. Anderson Cancer Center
🩺 Plain-English Summary (8th-Grade Level)
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (14 items).
Location: MD Anderson Cancer Center — Houston, Texas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- MD Anderson Cancer Center — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.