Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Purpose
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.
Condition
- Unresectable Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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) in the metastatic setting (prior 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prebiotic food-enriched diet (PreFED) |
Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet. |
|
Recruiting Locations
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
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