Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (PET/CT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in ctDNA level from baseline to 3-4 week after the start of therapy
研究概览
简要总结
The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.
详细描述
This is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18F-FDG PET/CT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients.
Primary Objective
• To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients.
Secondary Objectives
- To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT predicts development of clinical irAEs in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts progression-free survival (PFS) in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts overall survival (OS) in advanced melanoma patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Willing to provide informed consent.
- •Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other ICI therapy, is planned.
- •Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.
- •Individuals at least 18 years of age.
- •Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.
- •Willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Not able to receive treatment with ICI therapy
- •Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
- •Women who are pregnant, lactating, or planning on becoming pregnant during the study.
- •Not suitable for study participation due to other reasons at the discretion of the investigators.
结局指标
主要结局
Change in ctDNA level from baseline to 3-4 week after the start of therapy
时间窗: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
ctDNA level is monitored per standard of care in this population, data from chart review.
Change in 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
时间窗: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Lesion-level and patient-level 18F-FDG PET/CT response assessment at baseline and at 3-4 weeks after starting ICI therapy reported as SUV max.
Correlation between ctDNA level change and 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
时间窗: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Correlate lesion-level and patient-level 18F-FDG PET/CT response assessment at baseline and at 3-4 weeks after starting ICI therapy with quantitative changes in ctDNA levels at baseline and at 3-4 weeks after starting ICI therapy. Pearson's or Rank's correlation coefficient will be used to measure the baseline measures for ctDNA level trends and PET/CT responses and for those measurements at 3-4 weeks.
Diagnostic Accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition as measured by Area under the Curve
时间窗: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Receiver-operator curve analysis will be performed to determine the diagnostic accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition (area under the curve).
次要结局
- Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and PFS(up to 3 years after the first ICI dose (approximately 3 years on study))
- Overall Survival (OS)(up to 3 years after the first ICI dose (approximately 3 years on study))
- Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and OS(up to 3 years after the first ICI dose (approximately 3 years on study))
- Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)(up to 12 months after the first ICI dose (approximately 1 year on study))
- Objective Response Rate (ORR)(up to 12 months after the first ICI dose (approximately 1 year on study))
- Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and PFS(up to 3 years after the first ICI dose (approximately 3 years on study))
- Disease Control Rate (DCR)(up to 12 months after the first ICI dose (approximately 1 year on study))
- Progression Free Survival (PFS)(up to 3 years after the first ICI dose (approximately 3 years on study))
- Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and OS(up to 3 years after the first ICI dose (approximately 3 years on study))