RecruitingPhase 2NCT06466434
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
75 participants
Start Date
Sep 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether eating a diet rich in prebiotics (foods that feed beneficial gut bacteria) can improve how well immunotherapy drugs work against advanced melanoma (a serious skin cancer) by boosting the gut microbiome.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed with advanced stage III or IV melanoma that cannot be surgically removed
- You are about to start first-line immunotherapy (anti-PD1 or similar drug)
- Your BMI is between 18.5 and 45
- You speak English and can return to MD Anderson for follow-up visits
**You may NOT be eligible if...**
- You have previously received immunotherapy in the metastatic setting (prior adjuvant use may be allowed)
- You have symptomatic brain metastases
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
OTHERPrebiotic Food-Enriched Diet
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06466434
Related Trials
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
NCT0589683926 locations
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
NCT05136196221 locations
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
NCT066246449 locations
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
NCT0572790475 locations
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
NCT052693811 location