ICB-refractory MelanomaPhase 2NCT06250335
Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
A Phase 2 study testing Prebiotic Food-Enriched Diet, Ipilimumab and Nivolumab in people with ICB-refractory 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 ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICB-refractory Melanoma
- What is being tested?
- Prebiotic Food-Enriched Diet, Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 23 Jan 2029
- Phase
- Phase 2
- 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
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary Objectives Determining the overall response rate (ORR) to PreFED intervention + Ipi/Nivo in ICB-refractory metastatic melanoma participants.
Secondary Objectives
- Determine progression-free survival (PFS) and overall survival (OS) to PreFED + Ipi/Nivo in ICB refractory melanoma
- Compliance and adherence to interventions
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
- Assess the rate of immune related adverse events in participants on immunotherapy receiving dietary interventions
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on gut microbiome composition and networks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism
- Assess the effects of dietary interventions on quality of life and other participant reported outcomes (PROs)
- Conditions
- ICB-refractory Melanoma
- Being tested
- Prebiotic Food-Enriched Diet, Ipilimumab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic Food-Enriched DietOther
Also called PreFED
Given by PO
IpilimumabDrug
Given by IV
NivolumabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in diet. Receives: Other: Prebiotic Food-Enriched Diet; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted9 Feb 2024
- Study start1 Mar 2024
- Primary completion23 Jan 2027 (estimated)
- Study completion23 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICB-refractory 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erez Baruch, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250335
- Sponsor's protocol ID
- 2023-1067
- Other IDs
- NCI-2024-01235
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
- ClinicalTrials.gov ID
- NCT06250335
- Acronym / sponsor ID
- 2023-1067
- Conditions
- ICB-refractory Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 23 Jan 2027 (estimated)
- Study completion
- 23 Jan 2029 (estimated)
- First posted
- 9 Feb 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 ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.
Detailed description
Primary Objectives Determining the overall response rate (ORR) to PreFED intervention + Ipi/Nivo in ICB-refractory metastatic melanoma participants.
Secondary Objectives
- Determine progression-free survival (PFS) and overall survival (OS) to PreFED + Ipi/Nivo in ICB refractory melanoma
- Compliance and adherence to interventions
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
- Assess the rate of immune related adverse events in participants on immunotherapy receiving dietary interventions
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on gut microbiome composition and networks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism
- Assess the effects of dietary interventions on quality of life and other participant reported outcomes (PROs)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Prebiotic Food-Enriched Diet, Drug: Ipilimumab, Drug: NivolumabPatients receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 DietAlso: PreFEDGiven by PO | Other | Arm 1 |
| IpilimumabGiven by IV | Drug | Arm 1 |
| NivolumabGiven by IV | Drug | Arm 1 |
Primary outcome
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.
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 11 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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. This study is not recruiting at the moment.
Erez Baruch, MD 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 Phase 2 study testing Prebiotic Food-Enriched Diet, Ipilimumab and Nivolumab in people with ICB-refractory 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 10 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (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 11 Aug 2026.