BESPOKE Study of ctDNA Guided Immunotherapy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04761783
Study type	Observational
Source	Natera, Inc.
Contact
Status	Active, not recruiting
Phase
Start date	May 28, 2021
Completion date	May 2024

View Details

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