Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
- Conditions
- Melanoma
- Registration Number
- NCT06548789
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria:<br><br> 1. Age = 18 years old.<br><br> 2. Body mass index (BMI) 18.5-45 kg/m2<br><br> 3. English-speaking<br><br> 4. ECOG performance status of 0 or 1<br><br> 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV<br> cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by<br> multidisciplinary review<br><br> 6. Planned initiation of standard-of-care neoadjuvant Ipilimumab + Nivolumab or<br> Nivolumab + Relatlimab<br><br> 7. Measurable disease per RECIST 1.1<br><br> 8. WOCP must have negative UPT within 1 week of beginning dietary intervention.<br><br> 9. Self-reported willingness to eat the provided foods (with some tailoring to their<br> food preferences)<br><br> 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture,<br> provide stool samples.<br><br> 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of<br> care treatment.<br><br>Exclusion Criteria:<br><br> 1. Uveal melanoma<br><br> 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery<br><br> 3. Currently taking steroids > Prednisone 10 mg/day or equivalent<br><br> 4. Medical contraindications to the Intervention Diet as determined by the treating<br> physician.<br><br> 5. Self-reported major dietary restrictions, including but not limited to relevant food<br> allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.<br><br> 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants<br><br> 7. Unable or unwilling to undergo study procedures.<br><br> 8. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks<br><br> 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and<br> unable/unwilling to discontinue for the purpose of the study<br><br> 10. Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit<br> drug use<br><br> 11. Currently pregnant, planning to become pregnant, or lactating<br><br> 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy<br><br> 13. Cognitively impaired adults
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The completion rate, compliance and adherence.
- Secondary Outcome Measures
Name Time Method