Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

Korábbi kezelés

• Prior treatment with anti-CTLA4
• Concurrent malignancy requiring systemic therapy other than hormonal therapy.
• Currently taking steroids > Prednisone 10 mg/day or equivalent
• Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.

Más betegség

• History of inflammatory bowel disease, total colectomy, or bariatric surgery
• 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.

Egyéb

• Mucosal or uveal melanoma
• 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.
• Medical contraindications to the Intervention Diet as determined by the treating physician.
• Currently pregnant, planning to become pregnant, or lactating.
• Cognitively impaired adults

• Age ≥ 18 years old
• English-speaking
• Body mass index (BMI) 18.5-45 kg/m2
• ECOG performance status of 0 or 1
• Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic brain metastases are allowed.
• Prior treatment with anti-PD1 or anti-PD-1 + anti-LAG3 agents and documented disease progression either while on these agents or after stopping therapy without intervening therapy.
• Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg
• Measurable disease per RECIST 1.1
• 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.