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New treatment option for Unresectable Melanoma
Official title Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
ClinicalTrials.gov ID: NCT06466434
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Insulin-dependent diabetes or condition requiring bile acid sequestrants
See the full eligibility criteria
- 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...
- 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.