Can a special diet help immunotherapy work again in melanoma?
NCT ID NCT06250335
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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4 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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