Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.
详细描述
PRIMARY OBJECTIVE:
I. To compare progression-free survival among participants receiving immunotherapy based on time of day (ToD) administration (early versus [vs.] late).
SECONDARY OBJECTIVES:
I. To compare overall survival among participants receiving immunotherapy based on ToD administration (am vs. pm).
II. To compare rates of significant immune-related adverse events (irAEs) based on ToD administration (am vs. pm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Must provide written informed consent before any study-specific procedures or interventions are performed
- •Aged ≥ 18 years
- •Histologically confirmed advanced/metastatic solid tumor as follows:
- •Non small cell lung cancer (NSCLC) (driver-negative, immune checkpoint inhibitor [ICI]-eligible)
- •Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (platinum-eligible),
- •Renal cell carcinoma (RCC)
- •Biliary-tract cancer (BTC)
- •Hepatocellular carcinoma (HCC)
- •Planned to receive a Food and Drug Administration (FDA)-approved immune check point inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) regimen for the treatment of their malignancy
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
排除标准
- •Prior ICI-based regimen for treatment of cancer
- •Current or prior use of immunosuppressive medication within 28 days before planned standard-of-care immunotherapy infusion, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone (or equivalent corticosteroid)
- •Uncontrolled autoimmune disease requiring immunosuppression
- •Active, uncontrolled central nervous system (CNS) metastases
研究组 & 干预措施
Treatment (AM cohort)
Patients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
干预措施: Immune Checkpoint Inhibitor (Drug)
Treatment (AM cohort)
Patients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (PM cohort)
Patients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (PM cohort)
Patients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
干预措施: Immune Checkpoint Inhibitor (Drug)
结局指标
主要结局
Progression free survival
时间窗: From date of randomization to date of first progression or death (any cause), whichever occurs first (up to 2 years from date of last dose of standard-of-care immune checkpoint inhibitor [ICI])
The associated 95% confidence interval (CI) for each treatment group will be estimated using the Kaplan-Meier method. The stratified hazard ratio (HR) and its 95% CI will be estimated using a Cox proportional-hazard model with treatment group as the independent variable and stratified by the same randomization stratification factors as were used for the log-rank test.
次要结局
- Overall survival (OS)(From date of randomization to date of death (any cause) up to 2 years from date of last dose of standard-of-care ICI)
- Incidence of immune related adverse event (irAE) related time to treatment discontinuation(From date of first dose of standard-of-care ICI to date of last dose of standard-of-care ICI (an average of 2 years).)
研究者
Rajat Thawani
Principal Investigator
OHSU Knight Cancer Institute