Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06548789

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

Led by M.D. Anderson Cancer Center · Updated on 2026-02-06

35

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Body mass index (BMI) between 18.5 and 45 kg/m2
  • Able to complete study assessments on diet and gastrointestinal symptoms
  • ECOG performance status of 0 or 1
  • Histologically confirmed resectable stage IIIB-D or oligometastatic stage IV cutaneous melanoma or locally advanced mucosal melanoma
  • Planned start of standard neoadjuvant ipilimumab with or without nivolumab or nivolumab with or without relatlimab
  • Measurable disease according to RECIST 1.1 criteria
  • Women of childbearing potential must have a negative pregnancy test within 1 week before starting diet intervention
  • Willing to eat provided foods with some customization for preferences
  • Willing to comply with scheduled visits, blood draws, and stool sample collection
  • Archival tissue available or planned tumor biopsy as part of standard care
Not Eligible

You will not qualify if you...

  • Diagnosis of uveal melanoma
  • History of inflammatory bowel disease, total colectomy, or bariatric surgery
  • Taking steroids above prednisone 10 mg/day or equivalent
  • Medical reasons preventing the dietary intervention
  • Major dietary restrictions such as significant food allergies, celiac disease, vegan or ketogenic diets, or extended fasting
  • Insulin-dependent diabetes or need for bile-acid sequestrants
  • Unable or unwilling to follow study procedures
  • Intravenous antibiotic use more than 1 dose in past month or any antibiotic use in past 2 weeks
  • Regularly taking prebiotic, fiber, or probiotic supplements and unwilling to stop them
  • Current smoker, heavy alcohol use (>14 drinks/week), or illicit drug use
  • Currently pregnant, planning pregnancy, or breastfeeding
  • Other active cancers requiring systemic therapy except hormonal therapy
  • Cognitive impairment preventing participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

E

Erez Baruch, MD,PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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