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

NCT06250335 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-1067NCI-2024-01235
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ICB-refractory Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Other: Prebiotic Food-Enriched Diet; Drug: Ipilimumab; Drug: Nivolumab

Interventions

Ipilimumab DRUG

Given by IV

Arm 1

Nivolumab DRUG

Given by IV

Arm 1

Prebiotic Food-Enriched Diet OTHER

Given by PO

Also known as: PreFED

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Ipilimumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Erez Baruch, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 23, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)