Overview
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:
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases
- Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases.
- Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles of neoadjuvant ICB + diet
- Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention
- Determine the Event-free Survival (EFS), Relapse-free Survival (RFS), and Overall Survival (OS) to neoadjuvant ICB + dietary intervention
Exploratory Objectives:
- Assess the effect of dietary intervention + ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase
- Assess the effects of dietary intervention + neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase
- Assess the effects of dietary intervention + neoadjuvant ICB on systemic and tumor immunity at time of surgery
- Assess the effects of dietary intervention + neoadjuvant ICB on quality of life and other patient reported outcomes (PROs) during neoadjuvant and maintenance phases
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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