NCT06466434招募中2 期
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
研究概览
简要总结
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
详细描述
Primary Objectives
• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks
Secondary Objectives
- Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)
- Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens
- Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
- Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks
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
- •English-speaking
- •Body mass index (BMI) 18.5-45 kg/m2
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
- •Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
- •Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
- •Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
- •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.
排除标准
- •Previous ICB treatment in the metastatic setting
- •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 condition requiring bile acid sequestrants
- •Unable or unwilling to undergo study procedures.
- •IV antibiotic use in the past month or 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)
Experimental
Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.
干预措施: Prebiotic Food-Enriched Diet (Other)
结局指标
主要结局
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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