Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
研究概览
简要总结
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
详细描述
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. The study includes a control population of patients receiving standard chemotherapy as a comparator. Patients will undergo blood draws at 4 time-points while on standard of care treatment. There are no study-related medications or interventions beyond blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
- •≥18 years of age
- •Life expectancy >6 months
- •Starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) OR Starting new regimen of standard cytotoxic chemotherapy (control arm only)
- •Provision to sign and date the consent form
- •Stated willingness to comply with all study procedures and be available for the duration of the study
排除标准
- •Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
- •Known autoimmune disease
- •Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
- •Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
- •Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
- •Known pregnancy or lactation
研究组 & 干预措施
Immune Checkpoint Inhibitor Therapy
Patients starting treatment with ipilimumab, nivolumab, pembrolizumab, or atezolizumab, alone or in combination, for treatment of a metastatic solid tumor cancer will be enrolled. Patients will receive checkpoint inhibitor therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
干预措施: Blood Testing (Other)
Control
An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol
干预措施: Blood Testing (Other)
结局指标
主要结局
Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
时间窗: 30 Months
Difference in baseline inflammatory/autoimmune marker(s) in patients developing immune-related adverse events on immune checkpoint inhibitor therapy according to CTCAE v 4.0 versus those who do not
次要结局
- Change in inflammatory/autoimmune markers.(6 Months)
- Change in inflammatory/autoimmune markers(6 months)