BESPOKE Study of ctDNA Guided Immunotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Natera, Inc.
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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)
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
- •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
Outcomes
Primary Outcomes
Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy
Time Frame: 2 years
Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result
Secondary Outcomes
- 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)