CompletedNot applicableNCT04761783

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.

Checked against the public recordLast updated Aug 15, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorNatera, Inc.
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Natera, Inc.
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Prospective Inclusion Criteria: 1. Male or female patients 18 years of age or older at the time of signing informed consent form (ICF) 2. Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts: 1. Melanoma 2. Non-small cell lung cancer 3. Colorectal cancer 3. 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: 1. Pembrolizumab (Keytruda) 2. Nivolumab (Opdivo) 3. Ipilimumab (Yervoy) 4. Durvalumab (Imfinzi) 5. Cemiplimab (Libtayo) 6. Atezolizumab (Tecentriq) 7. Avelumab (Bavencio) 4. 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. 5. 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 6. ECOG Performance status 0,1, or 2 7. Able to read, understand and provide written informed consent 8. Willing and able to comply with the study requirements 9. 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: 1. Female patients that are pregnant 2. History of bone marrow or organ transplant 3. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder 4. Serious medical condition that may adversely affect ability to participate in the study 5. Has initiated Immunotherapy Control Arm Inclusion Criteria: 1. Male or female patients 18 years of age or older at the time of signing informed consent form (ICF) 2. Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts: 1. Melanoma 2. Non-small cell lung cancer 3. Colorectal cancer 3. 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: 1. Pembrolizumab (Keytruda) 2. Nivolumab (Opdivo) 3. Ipilimumab (Yervoy) 4. Durvalumab (Imfinzi) 5. Cemiplimab (Libtayo) 6. Atezolizumab (Tecentriq) 7. Avelumab (Bavencio) 4. 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. 5. 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 6. ECOG Performance status 0,1, or 2 7. Able to read, understand and provide written informed consent 8. Willing and able to comply with the study requirements 9. Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice Control Arm Exclusion Criteria: 1. Female patients that are pregnant 2. History of bone marrow or organ transplant 3. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder 4. Serious medical condition that may adversely affect ability to participate in the study 5. Has initiated Immunotherapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NateraSan Carlos, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2024. Always confirm current availability with the study team.

View original record ↗