Tests a prebiotic food diet alongside immunotherapy in melanoma patients before surgery
Tests a prebiotic food diet with immunotherapy in adults having melanoma surgery.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2
Where in United States
- MD Anderson Cancer CenterHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT06548789
- Record updated
- 25 September 2026
- Original description
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.Read full original descriptionShow less
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Inclusion: 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 anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec (T-VEC); 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.
Exclusion: Currently taking steroids > prednisone 10 mg/day or equivalent; Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use; Concurrent malignancy requiring systemic therapy other than hormonal therapy; History of inflammatory bowel disease, total colectomy, or bariatric surgery; 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; Uveal melanoma; Medical contraindications to the intervention diet as determined by the treating physician; 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; Currently pregnant, planning to become pregnant, or lactating; Cognitively impaired adults.