Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06466434
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old
* Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
* Body mass index (BMI) 18.5-45 kg/m2
* 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) in the metastatic setting (prior ICB in adjuvant setting is allowed if last exposure ≥ 6 months prior). Prior targeted therapy is also allowed.
* Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06466434
Study Brief:
Protocol Section:
NCT06466434