Recruiting
Phase 2

Immune Checkpoint Blockade & Prebiotic

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06548789

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prebiotic Xnack Packouts

Study Details

Brief summary:

To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

Conditions

Melanoma

Study ID

NCT06548789

Start date

Sep 16, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prebiotic food-enriched diet (PreFED)

Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.

Interventions

Prebiotic Xnack Packouts

Prebiotic snack packouts (distributed every two weeks) and diet counseling to support increased consumption of prebiotic foods which provide dietary fiber, plant-based protein and other nutrients selectively fermented by the microbiome (e.g., pulses and legumes).

Primary outcome measure

  • The completion rate, compliance and adherence. [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-02-06.