Effects of a prebiotic diet combined with immune therapy in melanoma patients

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

This study is testing if a special diet with prebiotics can help melanoma patients who aren't responding to standard immune therapies feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: Ipilimumab, Nivolumab, Prednisone, immunotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06250335 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of a prebiotic food-enriched diet (PreFED) on patients with ICB-refractory melanoma who are receiving the immune checkpoint inhibitors ipilimumab and nivolumab. The primary objective is to determine the overall response rate to the combination of PreFED and these therapies. Secondary objectives include assessing progression-free survival, overall survival, safety, tolerability, immune-related adverse events, and changes in gut microbiome composition. The study also aims to evaluate the dietary intervention's effects on quality of life and participant-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable stage III/IV melanoma who have previously shown disease progression on anti-PD1 therapies.

Not a fit: Patients with mucosal or uveal melanoma or those who have received prior anti-CTLA4 treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of immune therapies in melanoma patients who have not responded to previous treatments.

How similar studies have performed: While the combination of dietary interventions with immunotherapy is a novel approach, similar studies have shown promising results in enhancing treatment responses.

Eligibility 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

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer McQuade, MD — M.D. Anderson Cancer Center
• Study coordinator: Jennifer McQuade, MD

Conditions ICB-refractory Melanoma