Clinical trial · Interventional
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
NCT06548789CI-TRIAL-00102633recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prebiotic Xnack Packouts | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prebiotic food-enriched diet (PreFED)
- description
- Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.
- interventionNames
- Dietary Supplement: Prebiotic Xnack Packouts
Primary outcomes (1)
- measure
- The completion rate, compliance and adherence.
- timeFrame
- Up to 2 years
- description
- The completion rate is defined as proportion of participants completed the intervention. Among subjects that complete the PreFED intervention, compliance is defined as the proportion (%) of prebiotic snacks consumed versus provided and proportion (%) of counselling sessions attended, while adherence is defined as the number of servings of prebiotic foods the participant consumed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Body mass index (BMI) 18.5-45 kg/m2 3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden 4. ECOG performance status of 0 or 1 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review 6. Planned initiation of standard-of-care neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec (T-VEC) 7. Measurable disease per RECIST 1.1 8. WOCP must have negative UPT within 1 week of beginning dietary intervention. 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. 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment. Exclusion Criteria: 1. Uveal melanoma 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery 3. Currently taking steroids \> prednisone 10 mg/day or equivalent 4. Medical contraindications to the intervention diet as determined by the treating physician 5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants 7. Unable or unwilling to undergo study procedures 8. Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study 10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use 11. Currently pregnant, planning to become pregnant, or lactating 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy 13. Cognitively impaired adults
References
Publications (0)
Data not yet available
No reference posted for this study.