Combining immune therapy with a special diet for melanoma treatment

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

This study is testing if a special diet combined with immune therapy can help people with melanoma feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: ipilimumab, nivolumab, relatlimab, prednisone
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06548789 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the feasibility and adherence of a prebiotic dietary intervention in patients with resectable melanoma who are starting neoadjuvant immune checkpoint blockade therapy. The study will assess safety, tolerability, and the impact of the dietary intervention on immune responses and patient outcomes. Key objectives include measuring the objective response rate, pathological response rate, and various survival metrics, as well as exploring changes in gut microbiome composition and patient quality of life. Participants will receive a specific prebiotic food intervention alongside standard immune therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resectable stage IIIB-D or oligometastatic stage IV melanoma who are starting neoadjuvant immune therapy.

Not a fit: Patients with uveal melanoma or those with a history of inflammatory bowel disease or certain surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the immune response in melanoma patients, potentially improving treatment outcomes.

How similar studies have performed: While the combination of dietary interventions with immune therapies is an emerging area, similar studies have shown promise in enhancing treatment responses, though this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Body mass index (BMI) 18.5-45 kg/m2
3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
4. ECOG performance status of 0 or 1
5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
6. Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab
7. Measurable disease per RECIST 1.1
8. WOCP must have negative UPT within 1 week of beginning dietary intervention.
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.
11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

Exclusion Criteria:

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

Where this trial is running

Houston, Texas

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

Study contacts

• Principal investigator: Erez Baruch, MD,PHD — M.D. Anderson Cancer Center
• Study coordinator: Erez Baruch, MD,PHD

Conditions Melanoma