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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ICB-refractory Melanoma
• Intervention / Treatment: Drug: Nivolumab; Drug: Ipilimumab; Other: Prebiotic Food-Enriched Diet

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in diet.	Drug: Nivolumab; Given by IV; Drug: Ipilimumab; Given by IV; Other: Prebiotic Food-Enriched Diet; Given by PO; Other Names: PreFED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	ORR is defined as the proportion of participants whose best overall response BOR is either CR or PR. Best overall response is defined as the best response designation recorded between the date of first dose and the date of first objectively documented progression or the date of subsequent therapy, whichever occurs first per RECIST v1.1.	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Erez Baruch, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 23, 2029

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Ipilimumab
• Other Study ID Numbers: 2023-1067; NCI-2024-01235 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No