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

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

NCT ID: NCT06466434

Condition: Unresectable Melanoma

Conditions: Official terms:
Melanoma

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Prebiotic Food-Enriched Diet
Description: Given by PO
Arm group label: Prebiotic food-enriched diet (PreFED)

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥18 years old - Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden - Body mass index (BMI) 18.5-45 kg/m2 - ECOG performance status of 0 or 1 - Histologically confirmed stage III/IV, unresectable cutaneous 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 adjuvant setting is allowed if last exposure ≥ 6 months prior). Prior targeted therapy is also allowed. - Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally) - 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: - Uveal melanoma 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer McQuade, MD

Phone: (713) 745-9947
Email: jmcquade@mdanderson.org

Contact backup:
Last name: Jennifer McQuade, MD

Start date: September 4, 2024

Completion date: June 30, 2029

Lead sponsor:
Agency: M.D. Anderson Cancer Center
Agency class: Other

Source: M.D. Anderson Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06466434
http://www.mdanderson.org