Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Korábbi kezelés

• Previous ICB treatment in the metastatic setting
• 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.
• Concurrent malignancy requiring systemic therapy other than hormonal therapy.

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 condition requiring bile acid sequestrants

Egyéb

• Medical contraindications to the Intervention Diet as determined by the treating physician.
• 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.
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
• Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
• Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
• Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
• 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.