Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The completion rate, compliance and adherence.
研究概览
简要总结
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
详细描述
Primary Objectives:
Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy.
Secondary Objectives:
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases
- Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases.
- Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles of neoadjuvant ICB + diet
- Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention
- Determine the Event-free Survival (EFS), Relapse-free Survival (RFS), and Overall Survival (OS) to neoadjuvant ICB + dietary intervention
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Prebiotic food-enriched diet (PreFED)
Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.
干预措施: Prebiotic Xnack Packouts (Dietary Supplement)
结局指标
主要结局
The completion rate, compliance and adherence.
时间窗: Up to 2 years
The completion rate is defined as proportion of participants completed the intervention. Among subjects that complete the PreFED intervention, compliance is defined as the proportion (%) of prebiotic snacks consumed versus provided and proportion (%) of counselling sessions attended, while adherence is defined as the number of servings of prebiotic foods the participant consumed.
次要结局
未报告次要终点