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Recruiting
NCT06466434
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Conditions: Unresectable Melanoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 75
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
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.
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
Source: ClinicalTrials.gov (NCT06466434). StuddyBuddy aggregates publicly available trial information.