NCT04761783

BESPOKE Study of ctDNA Guided Immunotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Melanoma
• Non-small Cell Lung Cancer

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-12-31
• Completion: 2024-03-30
• First posted: 2021-02-21
• Last updated: 2024-08-15

Locations

1 site across 1 country: United States