RecruitingRecruiting
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
NCT06466434 · M.D. Anderson Cancer Center
In plain English
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About this study
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
Eligibility criteria
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
Study design
Enrollment target: 75 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-01
Estimated completion: 2029-06-30
Last updated: 2026-03-24
Interventions
Other: Prebiotic Food-Enriched Diet
Primary outcomes
- • Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline. (Up to 2 years)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactErez Baruch, MD,PHD · contact · ENBaruch@mdanderson.org, · 713-745-5530
InvestigatorErez Baruch, MD,PHD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States