Tests a prebiotic food diet alongside immunotherapy for melanoma
Tests a prebiotic-enriched diet in adults with unresectable melanoma starting immunotherapy.
Plain-language title generated from the registry record
Registry title: Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Key facts
- Where
- Houston, United StatesSee the site
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
- NCT06466434
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
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.
Inclusion: 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.
Exclusion: Previous ICB treatment in the metastatic setting; 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 condition requiring bile acid sequestrants; Medical contraindications to the Intervention Diet as determined by the treating physician; 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; Currently pregnant, planning to become pregnant, or lactating; Cognitively impaired adults.