Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

Study Purpose

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years old. 2. English-speaking. 3. Body mass index (BMI) 18.5-45 kg/m2. 4. ECOG performance status of 0 or 1. 5. Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic brain metastases are allowed. 6. Prior treatment with anti-PD1 or anti-PD-1 + anti-LAG3 agents and documented disease progression either while on these agents or after stopping therapy without intervening therapy. 7. Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg. 8. Measurable disease per RECIST 1.1. 9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences) 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.

Exclusion Criteria:

1. Prior treatment with anti-CTLA4. 2. Mucosal or uveal melanoma. 3. Concurrent malignancy requiring systemic therapy other than hormonal therapy. 4. History of inflammatory bowel disease, total colectomy, or bariatric surgery. 5. Currently taking steroids > Prednisone 10 mg/day or equivalent. 6. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks. 7. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study. 8. Medical contraindications to the Intervention Diet as determined by the treating physician. 9. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting. 10. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants. 11. Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use. 12. Currently pregnant, planning to become pregnant, or lactating. 13. Cognitively impaired adults

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06250335
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jennifer McQuade, MD
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	ICB-refractory Melanoma
Study Website:	View Trial Website

Additional Details

Primary Objectives Determining the overall response rate (ORR) to PreFED intervention + Ipi/Nivo in ICB-refractory metastatic melanoma participants. Secondary Objectives. 1. Determine progression-free survival (PFS) and overall survival (OS) to PreFED + Ipi/Nivo in ICB refractory melanoma. 2. Compliance and adherence to interventions. 3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention. 4. Assess the rate of immune related adverse events in participants on immunotherapy receiving dietary interventions. 5. Assess the effects of dietary intervention on systemic and tumor immunity. 6. Assess the effect of dietary intervention on gut microbiome composition and networks. 7. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism. 8. Assess the effects of dietary interventions on quality of life and other participant reported outcomes (PROs)

Arms & Interventions

Arms

Experimental: Arm 1

Patients receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in diet.

Interventions

Other: - Prebiotic Food-Enriched Diet

Given by PO

Drug: - Ipilimumab

Given by IV

Drug: - Nivolumab

Given by IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Jennifer Leigh McQuade, MD

[email protected]

713-745-9947

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