BESPOKE Study of ctDNA Guided Immunotherapy
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|ClinicalTrials.gov Identifier: NCT04761783|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : March 24, 2021
|Condition or disease|
|Colorectal Cancer Melanoma Non-small Cell Lung Cancer|
● To examine the impact of SIGNATERA™ on clinical decision-making regarding continuation, discontinuation, escalation, or de-escalation of immunotherapy.
● 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.
|Study Type :||Observational|
|Estimated Enrollment :||1539 participants|
|Official Title:||BESPOKE Study of ctDNA Guided Immunotherapy|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Patients will receive SIGNATERA™ test results and the immunotherapy treatment regimen, dosing schedule, duration of treatment, number of cycles, and modifications during treatment will be at the discretion of the HCP. Patients will be followed for up to two years with periodic whole blood collection. Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded.
Control cases must have undergone immunotherapy treatment and have follow-up data available in their medical record at the participating site for two years following initiation of immunotherapy or death.
- 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
- To determine progression free survival according to ctDNA change [ Time Frame: 2 years ]Compare progression free survival, defined as the duration of time between enrollment and an increase in severity of disease as determined by patient's treating physician, between groups determined by change in ctDNA
- Determine overall survival according to ctDNA change [ Time Frame: 2 years ]Compare overall survival, defined as the duration of time between enrollment and death for any reason, between groups determined by change in ctDNA
- Determine response rate according to ctDNA change in cases with progression of disease on first or second tumor assessment and who continue treatment. [ Time Frame: 2 years ]Compare percentage of patients that experience partial or complete response during the study, between groups determined by change in ctDNA
- To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment. [ Time Frame: 2 years ]Compare progression free survival between groups determined by change in ctDNA
- To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response. [ Time Frame: 2 years ]Compare duration of response, defined as the length of time from initial response to disease progression, between groups determined by change in ctDNA
- 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. [ Time Frame: 2 years ]Among all patients that are clinically identified to experience partial or complete response, percentage that have at least 6 months durable clinical response as determined by ctDNA change
- 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 [ Time Frame: 2 years ]Percent of patients whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen
- Determine the impact of SIGNATERA in informing immunotherapy treatment decisions [ Time Frame: 2 years ]Percent of patients whose immunotherapy treatment regimen was changed as a result of SIGNATERA and/or whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen
- Determine the impact of SIGNATERA on patient reported outcomes [ Time Frame: 2 years ]
Assess patient anxiety levels and wellbeing in patients receiving SIGNATERA ctDNA test results.
Patient responses to patient reported outcome questionnaires:
Assess if SIGNATERA makes patients feel that they are receiving the right treatment and determine if patients will continue to use Signatera in the future to monitor their cancer.
Biospecimen Retention: Samples With DNA
There are two arms to this study: A prospective arm that will enroll 1539 patients, and a historical control (retrospective arm) that will enroll 513 patients.
Each participant in the Prospective arm will have received the commercially available SIGNATERA™ test.
Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research. The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761783
|Contact: Sarah Saywerfirstname.lastname@example.org|
|Principal Investigator:||Alexey Aleshin, MD||Natera, Inc.|