NCT06466434 · M.D. Anderson Cancer Center
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations