Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

Recruiting Phase 2 Interventional Study
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
35 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
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About This Trial

To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

Trial Locations
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Eligibility Criteria
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 cutan…
Contacts

Erez Baruch, MD,PHD

713-745-5530

ENBaruch@mdanderson.org,

CONTACT