Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
• 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.