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

August 7, 2026 updated by: M.D. Anderson Cancer Center
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Up to 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erez Baruch, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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