BESPOKE Study of ctDNA Guided Immunotherapy

Last updated: August 13, 2024
Sponsor: Natera, Inc.
Overall Status: Completed

Phase

N/A

Condition

Non-small Cell Lung Cancer

Colon Cancer; Rectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT04761783
20-043-NCP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Prospective Inclusion Criteria:

  1. Male or female patients 18 years of age or older at the time of signing informedconsent form (ICF)

  2. Any patient with documented metastatic or locally advanced, unresectable cancer ofthe types within the following cohorts:

  3. Melanoma

  4. Non-small cell lung cancer

  5. Colorectal cancer

  6. Patients must be clinically eligible and planned to receive therapy with ananti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1,anti-CTLA-4, or anti-PD-L1:

  7. Pembrolizumab (Keytruda)

  8. Nivolumab (Opdivo)

  9. Ipilimumab (Yervoy)

  10. Durvalumab (Imfinzi)

  11. Cemiplimab (Libtayo)

  12. Atezolizumab (Tecentriq)

  13. Avelumab (Bavencio)

  14. Patients must have measurable disease according to RECIST criteria, and at least onelesion that can be accurately measured in at least one dimension as >10 mm.

  15. Patients must be able to follow study visit schedule and willing to provide up to 20mL of peripheral blood samples at the indicated time points

  16. ECOG Performance status 0,1, or 2

  17. Able to read, understand and provide written informed consent

  18. Willing and able to comply with the study requirements

  19. Selected by their HCP to receive SIGNATERA testing according to the currentevidence-informed schedule as part of their routine of practice

Exclusion

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 blooddonation, such as bleeding disorder

  4. Serious medical condition that may adversely affect ability to participate in thestudy

  5. Has initiated Immunotherapy

Control Arm Inclusion Criteria:

  1. Male or female patients 18 years of age or older at the time of signing informedconsent form (ICF)

  2. Any patient with documented metastatic or locally advanced, unresectable cancer ofthe types within the following cohorts:

  3. Melanoma

  4. Non-small cell lung cancer

  5. Colorectal cancer

  6. Patients must be clinically eligible and planned to receive therapy with ananti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1,anti-CTLA-4, or anti-PD-L1:

  7. Pembrolizumab (Keytruda)

  8. Nivolumab (Opdivo)

  9. Ipilimumab (Yervoy)

  10. Durvalumab (Imfinzi)

  11. Cemiplimab (Libtayo)

  12. Atezolizumab (Tecentriq)

  13. Avelumab (Bavencio)

  14. Patients must have measurable disease according to RECIST criteria, and at least onelesion that can be accurately measured in at least one dimension as >10 mm.

  15. Patients must be able to follow study visit schedule and willing to provide up to 20mL of peripheral blood samples at the indicated time points

  16. ECOG Performance status 0,1, or 2

  17. Able to read, understand and provide written informed consent

  18. Willing and able to comply with the study requirements

  19. Selected by their HCP to receive SIGNATERA testing according to the currentevidence-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 blooddonation, such as bleeding disorder

  4. Serious medical condition that may adversely affect ability to participate in thestudy

  5. Has initiated Immunotherapy

Study Design

Total Participants: 290
Study Start date:
May 28, 2021
Estimated Completion Date:
March 30, 2024

Study 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.

Connect with a study center

  • Alabama Oncology

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Natera

    San Carlos, California 94070
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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