This clinical trial studies the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in patients with stage III-IV cutaneous, uveal, acral or mucosal melanoma that cannot be removed by surgery (unresectable) who are starting immune checkpoint inhibitor (ICI) therapy. The gut microbiome is the collection of microorganisms (like bacteria or fungi) that are present in the digestive system. PreFED is a diet intervention focused on behavior change and has some provision of whole foods (with no dietary supplements). Prebiotic foods, high in dietary fiber and other key nutrients, selectively support beneficial gut microbes that maintain the health of the overall gut ecosystem. Giving a PreFED in combination with standard of care ICI may help improve the gut microbiome and general health of patients with stage III or IV unresectable cutaneous, uveal, acral or mucosal melanoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06466434.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Jennifer McQuade
Phone: 713-745-9947
PRIMARY OBJECTIVE:
I. Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks.
SECONDARY OBJECTIVES:
I. Determine the best overall response rate (BORR) to PreFED + immune checkpoint blockade (ICB) regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance).
II. Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens.
III. Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks.
IV. Determine the safety (diet-related adverse events [AEs]) and tolerability (Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome [GSRS-IBS]) of the dietary intervention at 12 weeks and maintenance at 24 weeks.
V. Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks.
VI. Assess the effects of dietary intervention on systemic and tumor immunity.
VII. Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks.
VIII. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks.
IX. Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks.
OUTLINE:
Patients receive 2-3 prebiotic snacks per day and participate in diet counseling weekly for 12 weeks. Patients who complete the initial 12-week PreFED intervention and are continuing with maintenance immunotherapy continue diet counseling alone for an additional 12 weeks. Patients undergo computed tomography (CT) or positron emission tomography (PET) and magnetic resonance imaging (MRI), and blood sample collection throughout the trial. Patients may undergo optional tumor biopsies throughout the trial.
After completion of study intervention, patients follow up at 12 weeks and then every 6 months for up to 2 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJennifer McQuade
