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NCT04761783Completed

BESPOKE Study of ctDNA Guided Immunotherapy

Source: ClinicalTrials.gov · Last updated 15 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
290 (actual)
First submitted
16 Feb 2021
Start date
28 May 2021
Primary completion date
31 Dec 2023
Lead sponsor
Natera, Inc.
NCT number
NCT04761783

What you commit to

  • Study type: Observational
  • Participants enrolled: 290
  • From 28 May 2021 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Prospective 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 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 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Natera
Coordinator of this site? Confirm its status		San CarlosUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.