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

Обзор

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

Подробное описание

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

Вмешательства

• Пищевая добавка 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).

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• MD Anderson Cancer Center — Houston

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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