Unresectable MelanomaNCT06466434
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
A study testing Prebiotic Food-Enriched Diet in people with Unresectable Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Melanoma
- What is being tested?
- Prebiotic Food-Enriched Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- English-speaking
- Body mass index (BMI) 18.5-45 kg/m2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
- Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
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- Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
- Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
- WOCP must have negative UPT within 1 week of beginning dietary intervention.
- 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.
Who cannot join
- Previous ICB treatment in the metastatic setting
- History of inflammatory bowel disease, total colectomy, or bariatric surgery.
- Currently taking steroids > Prednisone 10 mg/day or equivalent
- 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 condition requiring bile acid sequestrants
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- Unable or unwilling to undergo study procedures.
- 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.
- Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.
- Currently pregnant, planning to become pregnant, or lactating.
- Concurrent malignancy requiring systemic therapy other than hormonal therapy.
- Cognitively impaired adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Erez Baruch, MD,PHD, 713-745-5530, ENBaruch@mdanderson.org,
Erez Baruch, MD,PHD
About this study
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Read the detailed description
Primary Objectives
- Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks
Secondary Objectives
- Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)
- Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens
- Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
- Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks
- Conditions
- Unresectable Melanoma
- Being tested
- Prebiotic Food-Enriched Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic Food-Enriched DietOther
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic food-enriched diet (PreFED) | Experimental | Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet. Receives: Other: Prebiotic Food-Enriched Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erez Baruch, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466434
- Sponsor's protocol ID
- 2024-0387
- Other IDs
- NCI-2024-05150
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
- ClinicalTrials.gov ID
- NCT06466434
- Acronym / sponsor ID
- 2024-0387
- Conditions
- Unresectable Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Detailed description
Primary Objectives
- Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks
Secondary Objectives
- Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)
- Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens
- Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
- Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prebiotic food-enriched diet (PreFED) | Experimental | Other: Prebiotic Food-Enriched DietParticipants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old
- English-speaking
- Body mass index (BMI) 18.5-45 kg/m2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
Key exclusion criteria (13 listed)
- Previous ICB treatment in the metastatic setting
- History of inflammatory bowel disease, total colectomy, or bariatric surgery.
- Currently taking steroids > Prednisone 10 mg/day or equivalent
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic Food-Enriched DietGiven by PO | Other | Prebiotic food-enriched diet (PreFED) |
Primary outcome
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erez Baruch, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic Food-Enriched Diet in people with Unresectable Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erez Baruch, MD,PHD (713-745-5530, ENBaruch@mdanderson.org,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.