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

NCT06548789 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DIETARY_SUPPLEMENT

Prebiotic Xnack Packouts

Prebiotic snack packouts (distributed every two weeks) and diet counseling to support increased consumption of prebiotic foods which provide dietary fiber, plant-based protein and other nutrients selectively fermented by the microbiome (e.g., pulses and legumes).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Erez Baruch, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2028-09-01
Completion
2030-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06548789 on ClinicalTrials.gov