BESPOKE Study of ctDNA Guided Immunotherapy

NCT04761783 | Completed

• 1 other identifier: 20-043-NCP
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Melanoma; Non-small Cell Lung Cancer

Keywords

BESPOKE; circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

• Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy

  Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result

  2 years

Secondary Outcomes (9)

• To determine progression free survival according to ctDNA change

  2 years

• Determine overall survival according to ctDNA change

  2 years

• Determine response rate according to ctDNA change in cases with progression of disease on first or second tumor assessment and who continue treatment.

  2 years

• To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment.

  2 years

• To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response.

  2 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have been diagnosed with advanced colorectal cancer, non-small cell lung cancer, or melanoma

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (1)

Natera

San Carlos, California, 94070, United States

Location

Related Publications (1)

• 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.

  PMID: 35636789 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

There are two arms to this study: A prospective arm that will enroll 1539 patients, and a historical control (retrospective arm) that will enroll 513 patients. Each participant in the Prospective arm will have received the commercially available SIGNATERA™ test. Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research. The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.

MeSH Terms

Conditions

Colorectal Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexey Aleshin, MD

  Natera, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: May 28, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)