Status:
RECRUITING
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Detailed Description
Primary Objectives: Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy. Secondary Objectiv...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Body mass index (BMI) 18.5-45 kg/m2
- English-speaking
- ECOG performance status of 0 or 1
- Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
- Planned initiation of standard-of-care neoadjuvant Ipilimumab + Nivolumab or Nivolumab + Relatlimab
- Measurable disease per RECIST 1.1
- 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.
- Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.
Exclusion
- Uveal melanoma
- 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 conditions 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06548789
Start Date
September 16 2024
End Date
September 1 2030
Last Update
October 30 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030