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Can a special diet help immunotherapy work again in melanoma?

NCT ID NCT06250335

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests whether a diet rich in prebiotic foods can help the immune system better fight advanced melanoma that no longer responds to standard immunotherapy. Four adults with stage III or IV melanoma will eat a prebiotic-enriched diet while receiving a combination of two immunotherapy drugs (ipilimumab and nivolumab). The goal is to see if the diet can improve tumor shrinkage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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