Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Recruiting Phase 2 Interventional Study
Unresectable Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
75 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion 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 …
Contacts

Erez Baruch, MD,PHD

713-745-5530

ENBaruch@mdanderson.org,

CONTACT