NCT04761783已完成不适用
BESPOKE Study of ctDNA Guided Immunotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Natera, Inc.
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy
研究概览
简要总结
This is a prospective data collection study of patients with advanced solid tumors who will receive standard of care immunotherapy (IO) and will be monitored with SIGNATERA™ testing. SIGNATERA™ test will be performed at baseline and during routine care. The test results will be part of assessing tumor response. The correlation between SIGNATERA™ test results and subsequent treatment decisions will be examined to compare actual treatment delivered against treatment decisions potentially impacted by SIGNATERA™ results. Treatment administered, tumor assessment results, time to progression, overall survival, physician questionnaires, and patient-reported outcomes will be collected/recorded.
详细描述
Primary Objective:
● To examine the impact of SIGNATERA™ on clinical decision-making regarding continuation, discontinuation, escalation, or de-escalation of immunotherapy.
Secondary Objective:
● To prospectively evaluate the utility of SIGNATERA™ as a tool to detect early evidence of response or progression in patients with advanced solid tumors receiving immune checkpoint inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
- •Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
- •Non-small cell lung cancer
- •Colorectal cancer
- •Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
- •Pembrolizumab (Keytruda)
- •Nivolumab (Opdivo)
- •Ipilimumab (Yervoy)
- •Durvalumab (Imfinzi)
- •Cemiplimab (Libtayo)
- •Atezolizumab (Tecentriq)
- •Avelumab (Bavencio)
- •Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
- •Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
- •ECOG Performance status 0,1, or 2
- •Able to read, understand and provide written informed consent
- •Willing and able to comply with the study requirements
- •Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice
- •Prospective
排除标准
- •Female patients that are pregnant
- •History of bone marrow or organ transplant
- •Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- •Serious medical condition that may adversely affect ability to participate in the study
- •Has initiated Immunotherapy
- •Control Arm Inclusion Criteria:
- •Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
- •Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
- •Non-small cell lung cancer
- •Colorectal cancer
- •Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
- •Pembrolizumab (Keytruda)
- •Nivolumab (Opdivo)
- •Ipilimumab (Yervoy)
- •Durvalumab (Imfinzi)
- •Cemiplimab (Libtayo)
- •Atezolizumab (Tecentriq)
- •Avelumab (Bavencio)
- •Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
- •Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
- •ECOG Performance status 0,1, or 2
- •Able to read, understand and provide written informed consent
- •Willing and able to comply with the study requirements
- •Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice
- •Control Arm Exclusion Criteria:
- •Female patients that are pregnant
- •History of bone marrow or organ transplant
- •Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- •Serious medical condition that may adversely affect ability to participate in the study
- •Has initiated Immunotherapy
结局指标
主要结局
Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy
时间窗: 2 years
Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result
次要结局
- To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment.(2 years)
- Determine overall survival according to ctDNA change(2 years)
- Determine the impact of SIGNATERA on the confidence in immunotherapy treatment decisions based on the number of patients in which treating physician reports SIGNATERA made them more confident in immunotherapy treatment regimen(2 years)
- To determine progression free survival according to ctDNA change(2 years)
- Determine response rate according to ctDNA change in cases with progression of disease on first or second tumor assessment and who continue treatment.(2 years)
- Determine the impact of SIGNATERA in informing immunotherapy treatment decisions(2 years)
- Determine the impact of SIGNATERA on patient reported outcomes(2 years)
- To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response.(2 years)
- To determine percentage of patients with at least 6 months of durable clinical response according to ctDNA change in patients who achieve at least partial response on best tumor assessment.(2 years)
研究者
研究点 (1)
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