Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
M.D. Anderson Cancer Center
Summary
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Description
Primary Objectives: Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy. Secondary Objectives: 1. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases 2. Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases. 3. Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 beginn…
Interventions
- Dietary SupplementPrebiotic Xnack Packouts
Prebiotic snack packouts (distributed every two weeks) and diet counseling to support increased consumption of prebiotic foods which provide dietary fiber, plant-based protein and other nutrients selectively fermented by the microbiome (e.g., pulses and legumes).
Location
- MD Anderson Cancer CenterHouston, Texas