NCT06250335Active, not recruitingPhase 2
Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 1 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 23 Jan 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT06250335
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 4
- From 1 Mar 2024 to the primary completion date, 23 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with anti-CTLA4
- Concurrent malignancy requiring systemic therapy other than hormonal therapy.
- Currently taking steroids \> Prednisone 10 mg/day or equivalent
- Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use.
Other illness
- History of inflammatory bowel disease, total colectomy, or bariatric surgery
- 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.
Other
- Mucosal or uveal melanoma
- 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.
- Medical contraindications to the Intervention Diet as determined by the treating physician.
- Currently pregnant, planning to become pregnant, or lactating.
- Cognitively impaired adults
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.