NCT06466434 Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
| NCT ID | NCT06466434 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Unresectable Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2024-09-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Erez Baruch, MD,PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06466434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unresectable Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06466434 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06466434 currently recruiting?
Yes, NCT06466434 is actively recruiting participants. Contact the research team at ENBaruch@mdanderson.org, for enrollment information.
Where is the NCT06466434 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06466434 clinical trial?
NCT06466434 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Erez Baruch, MD,PHD at M.D. Anderson Cancer Center. The trial plans to enroll 75 participants.
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