This phase II trial tests how well adding a prebiotic food enriched diet (PreFED) intervention to standard of care immune checkpoint blockade (ICB) before surgery (neoadjuvant) works to improve immune response in patients with stage IIIB-D cutaneous melanoma that can be removed by surgery (resectable), stage IV cutaneous melanoma that has spread from where it first started to a limited number of sites (oligometastatic), or mucosal melanoma has spread to nearby tissue or lymph nodes (locally advanced). The gut microbiome is the collection of microorganisms (like bacteria or fungi) that are present in the digestive system. It is associated with response to ICB in patients. Prebiotic foods, high in dietary fiber and other key nutrients, selectively support beneficial gut microbes that maintain the health of the overall gut environment. Adding a PreFED intervention to standard neoadjuvant ICB may help improve the gut microbiome and immune response in patients with resectable stage IIIB-D or stage IV cutaneous melanoma or locally advanced mucosal melanoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06548789.
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. Determining the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy.
SECONDARY OBJECTIVES:
I. Determine the safety (adverse events [AEs]) and tolerability (Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome [GSRS-IBS]) of the dietary intervention during the neoadjuvant phase and maintenance phases.
II. Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases.
III. Determine the objective response rate (ORR) to dietary intervention + ICB as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 after 2 cycles of neoadjuvant ICB + diet.
IV. Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention.
V. Determine the event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) to neoadjuvant ICB + dietary intervention.
EXPLORATORY OBJECTIVES:
I. Assess the effect of dietary intervention + ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase.
II. Assess the effects of dietary intervention + neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase.
III. Assess the effects of dietary intervention + neoadjuvant ICB on systemic and tumor immunity at time of surgery.
IV. Assess the effects of dietary intervention + neoadjuvant ICB on quality of life and other patient reported outcomes (PROs) during neoadjuvant and maintenance phases.
OUTLINE:
Patients receive 2-3 prebiotic snacks per day and receive nutritional counseling weekly for up to 9 weeks while receiving standard of care (SOC) ICB prior to surgery. Patients who complete the initial 9-week PreFED intervention without disease progression or change in therapy will continue nutritional counseling alone for an additional 8 weeks post-surgery. Patients also undergo computed tomography (CT) or positron emission tomography (PET) and magnetic resonance imaging (MRI) at screening and on study and undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 12 weeks and then every 6 months for up to 2 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJennifer McQuade
