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

Running, not enrolling · Phase 2

Conditions studied: ICB-refractory Melanoma

In brief

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.

Key facts

Study ID

NCT06250335

Run by

M.D. Anderson Cancer Center

People needed

4

Starts

2024-03-01

Expected to finish

2029-01-23

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 melanoma. Asymptomatic brain metastases are allowed.
• 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.
• Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg
• Measurable disease per RECIST 1.1
• 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.

You may not qualify if…

• Prior treatment with anti-CTLA4
• Mucosal or uveal melanoma
• Concurrent malignancy requiring systemic therapy other than hormonal therapy.
• History of inflammatory bowel disease, total colectomy, or bariatric surgery
• Currently taking steroids > Prednisone 10 mg/day or equivalent
• 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.
• 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 conditions requiring bile-acid sequestrants.
• Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.
• Currently pregnant, planning to become pregnant, or lactating.
• Cognitively impaired adults

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.