BESPOKE Study of ctDNA Guided Immunotherapy

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.

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:
Melanoma
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

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04761783.

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.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationNatera, Inc.

Primary ID20-043-NCP
Secondary IDsNCI-2021-11359
ClinicalTrials.gov IDNCT04761783

BESPOKE Study of ctDNA Guided Immunotherapy

Inclusion Criteria

Exclusion Criteria

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BESPOKE Study of ctDNA Guided Immunotherapy

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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