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

M.D. Anderson Cancer Center

Status and phase

Enrolling

Phase 2

Conditions

Unresectable Melanoma

Treatments

Other: Prebiotic Food-Enriched Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06466434

NCI-2024-05150 (Other Identifier)

2024-0387

Details and patient eligibility

About

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.

Full 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

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years old
English-speaking
Body mass index (BMI) 18.5-45 kg/m2
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 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