Status:
COMPLETED
BESPOKE Study of ctDNA Guided Immunotherapy
Lead Sponsor:
Natera, Inc.
Conditions:
Colorectal Cancer
Melanoma
Eligibility:
All Genders
18+ years
Brief 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 w...
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: ● T...
Eligibility Criteria
Inclusion
- Prospective
- 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
- 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 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
- Control Arm
Key Trial Info
Start Date :
May 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT04761783
Start Date
May 28 2021
End Date
March 30 2024
Last Update
August 15 2024
Active Locations (1)
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1
Natera
San Carlos, California, United States, 94070