Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
NCT06466434 · Phase 2 · Houston, Texas, United States
- Condition
- Melanoma
- Disease stage
- Stage I-IV
- Phase
- Phase 2
- Study type
- OTHER
- Intervention
- Prebiotic Food-Enriched Diet
- Age
- 18 Years to
- Gender
- All
- Sponsor
- M.D. Anderson Cancer Center
- Research institution
- M.D. Anderson Cancer Center
- Facility
- MD Anderson Cancer Center
- Research center
- MD Anderson Cancer Center
Summary
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Detailed description
Primary Objectives • Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks Secondary Objectives * Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance) * Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens * Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks * Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks * Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary intervention on systemic and tumor immunity * Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks * Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks
Inclusion criteria
* 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.
Exclusion criteria
* Previous ICB treatment in the metastatic setting * 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 condition 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
Primary outcomes
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.