NCT06548789 Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
| NCT ID | NCT06548789 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2028-09-01 |
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 35 participants in total. It began in 2024-09-16 with a primary completion date of 2028-09-01.
⚠ 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 Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Body mass index (BMI) 18.5-45 kg/m2 3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden 4. ECOG performance status of 0 or 1 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review 6. Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab 7. Measurable disease per RECIST 1.1 8. WOCP must have negative UPT within 1 week of beginning dietary intervention. 9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences) 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples. 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment. Exclusion Criteria: 1. Uveal melanoma 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery 3. Currently taking steroids \> prednisone 10 mg/day or equivalent 4. Medical contraindications to the intervention diet as determined by the treating physician 5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants 7. Unable or unwilling to undergo study procedures 8. Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study 10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use 11. Currently pregnant, planning to become pregnant, or lactating 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy 13. Cognitively impaired adults
Contact & Investigator
Erez Baruch, MD,PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06548789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying 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 NCT06548789 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 NCT06548789 currently recruiting?
Yes, NCT06548789 is actively recruiting participants. Contact the research team at ENBaruch@mdanderson.org, for enrollment information.
Where is the NCT06548789 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06548789 clinical trial?
NCT06548789 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 35 participants.
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