Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
概览
- 阶段
- 2 期
- 干预措施
- Prebiotic Food-Enriched Diet
- 疾病 / 适应症
- Unresectable Melanoma
- 发起方
- M.D. Anderson Cancer Center
- 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.
- 状态
- 招募中
- 最后更新
- 上个月
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
研究者
入排标准
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)
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.
研究组 & 干预措施
Prebiotic food-enriched diet (PreFED)
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
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