BESPOKE Study of ctDNA Guided Immunotherapy

NCT ID: NCT04761783

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-03-30

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 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.

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:

● 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.

Conditions

Colorectal Cancer; Melanoma; Non-small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective arm

Patients will receive SIGNATERA™ test results and the immunotherapy treatment regimen, dosing schedule, duration of treatment, number of cycles, and modifications during treatment will be at the discretion of the HCP. Patients will be followed for up to two years with periodic whole blood collection. Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded.

No interventions assigned to this group

Control arm

Control cases must have undergone immunotherapy treatment and have follow-up data available in their medical record at the participating site for two years following initiation of immunotherapy or death.

No interventions assigned to this group

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexey Aleshin, MD

Role: PRINCIPAL_INVESTIGATOR

Natera, Inc.

Locations

Natera

San Carlos, California, United States

Countries

United States

References

Kasi PM, Chakrabarti S, Sawyer S, Krainock M, Poklepovic A, Ansstas G, Maninder M, Malhotra M, Ensor J, Gao L, Eroglu Z, Ellers S, Billings P, Rodriguez A, Aleshin A. BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours. BMJ Open. 2022 May 30;12(5):e060342. doi: 10.1136/bmjopen-2021-060342.

Reference Type: DERIVED

PMID: 35636789 (View on PubMed)

Other Identifiers

20-043-NCP

Identifier Type: -

Identifier Source: org_study_id