Phase 2, Single Arm Study to Evaluate the Efficacy of Time Restricted Eating (TRE) on Immunotherapy Treatment Outcomes in Patients With Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Time restricted eating (TRE) associated change in gut microbiome
研究概览
简要总结
The purpose of this study is to evaluate whether Time Restricted Eating (TRE) can improve responses in participants with metastatic head and neck squamous cell cancer (mHNSCC) or unresectable/metastatic renal cell carcinoma (RCC) receiving Immune Checkpoint Blockers (ICB) by changing the gut microbiome (the bacteria and other microorganisms living in individual's bodies). A particular focus of this study is to compare the outcomes of African American participants when compared to the rest of the participant population. TRE is a form of intermittent fasting where food and drink intake is limited to a specific time window during the day. The information learned from this study may help researchers develop new strategies to improve outcomes in patients with mHNSCC and RCC in the future.
Participants will be asked to complete a dietary survey at baseline and week 9 and provide a baseline stool and blood sample. Two weeks before beginning ICB and after participants completed the baseline assessments, they will begin TRE. TRE will be defined as limiting food and drink intake to a 10 hour window during each day and fasting for 14 hours at night. Participants will be asked to complete a daily food log to document the times they eat and drink. On day 1 of ICB and weeks 3, 6, 9, 26, and 52 after ICB, participants will be asked to collect a blood sample and a toxicity assessment will be performed. On day 1 of ICB and weeks 9, 26, and 52 of ICB, participants will be asked to provide a stool sample. Participants will also undergo tumor imaging throughout the study as part of their standard of care assessments. If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Age ≥18 years, able to understand and voluntarily consent.
排除标准
- •Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia.
- •Ongoing or active infection requiring iv antibiotics, autoimmune disease requiring systemic steroids greater than prednisone 60 mg equivalent, symptomatic congestive heart failure, unstable angina pectoris, insulin use, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Eligible patients must be neurologically asymptomatic and not requiring steroids.
- •Has received prior therapy with any anti-PD-1, anti-PDL-1 in a metastatic setting.
- •Patients for whom fasting is medically contraindicated
- •Inclusion Criteria:
- •Histologically or cytologically confirmed unresectable/metastatic clear cell renal cell carcinoma that is not amenable to local therapy with curative intent (surgery, radiation therapy, cryoablation, etc.,) and initiating standard of care systemic therapy consisting of immune checkpoint blockade (e.g. ipilimumab/nivolumab, cabozantinib/nivolumab, lenvatinib/pembrolizumab, or axitinib/pembrolizumab) for the first time.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Age ≥18 years, able to understand and voluntarily consent.
- •Exclusion Criteria:
- •Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia.
- •Ongoing or active infection requiring iv antibiotics, autoimmune disease requiring systemic steroids greater than prednisone 60 mg equivalent, symptomatic congestive heart failure, unstable angina pectoris, insulin use, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Eligible patients must be neurologically asymptomatic and not requiring steroids.
- •Has received prior therapy with any anti-PD-1, anti-PDL-1
- •Patients for whom fasting is medically contraindicated
结局指标
主要结局
Time restricted eating (TRE) associated change in gut microbiome
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Microbiome changes in stool
Time restricted eating (TRE) associated change in metabolome
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Metabolomics in blood
Time restricted eating (TRE) associated change in IGF1
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
IGF1 level in blood
Time restricted eating (TRE) associated change in immune repertoire
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Comprehensive analysis of effector T cells and suppressor T cell populations in PBMC, plasma cytokines will be carried out
Response to immune checkpoint blocker (ICB) at first response assessment
时间窗: Week 9
Radiographic response as per RECIST 1.1
Median progression free survival (PFS) for HNSCC cohort only
时间窗: 1 Year
Time from enrollment to radiographic disease progression as per RECIST 1.1 or death from any cause
Time restricted eating (TRE) associated change in gut microbiome
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Microbiome changes in stool
Time restricted eating (TRE) associated change in metabolome
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Metabolomics in blood
Time restricted eating (TRE) associated change in IGF1
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
IGF1 level in blood
Time restricted eating (TRE) associated change in immune repertoire
时间窗: Baseline, Day 1, Week 9, Week 26 and Week 52
Comprehensive analysis of effector T cells and suppressor T cell populations in PBMC, plasma cytokines will be carried out
Response to immune checkpoint blocker (ICB) at first response assessment
时间窗: Week 9
Radiographic response as per RECIST 1.1
次要结局
- Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)(Through Week 52)
- 1-year immune related adverse events (irAE) rate in African American participants(1 year)
- 1-year immune related adverse events (irAE) rate(1 Year)
- Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)(Through Week 52)
- 1-year immune related adverse events (irAE) rate in African American participants(1 year)
- Median progression free survival (PFS) for RCC cohort only(1 Year)