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Recruiting NCT06548789

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

Phase II Interventional Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prebiotic Xnack Packouts.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

Primary Objectives:

Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy.

Secondary Objectives:

1. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases 2. Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases. 3. Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles of neoadjuvant ICB + diet 4. Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention 5. Determine the Event-free Survival (EFS), Relapse-free Survival (RFS), and Overall Survival (OS) to neoadjuvant ICB + dietary intervention

Exploratory Objectives:

1. Assess the effect of dietary intervention + ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase 2. Assess the effects of dietary intervention + neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase 3. Assess the effects of dietary intervention + neoadjuvant ICB on systemic and tumor immunity at time of surgery 4. Assess the effects of dietary intervention + neoadjuvant ICB on quality of life and other patient reported outcomes (PROs) during neoadjuvant and maintenance phases

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).

Primary outcome measures

  • The completion rate, compliance and adherence. [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old.
  • Body mass index (BMI) 18.5-45 kg/m2
  • Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
  • ECOG performance status of 0 or 1
  • Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
  • Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab
  • Measurable disease per RECIST 1.1
  • WOCP must have negative UPT within 1 week of beginning dietary intervention.
  • Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
  • Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
  • Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

Exclusion criteria

  • Uveal melanoma
  • History of inflammatory bowel disease, total colectomy, or bariatric surgery
  • Currently taking steroids > prednisone 10 mg/day or equivalent
  • Medical contraindications to the intervention diet as determined by the treating physician
  • Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting
  • Insulin-dependent diabetes or conditions requiring bile-acid sequestrants
  • Unable or unwilling to undergo study procedures
  • Intravenous (IV) antibiotic >1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks
  • Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study
  • Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use
  • Currently pregnant, planning to become pregnant, or lactating
  • Concurrent malignancy requiring systemic therapy other than hormonal therapy
  • Cognitively impaired adults

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06548789 · 2024-0388 · NCI-2024-06747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗