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BESPOKE Study of ctDNA Guided Immunotherapy

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ClinicalTrials.gov Identifier: NCT04761783
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.

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.

Condition or disease
Colorectal Cancer Melanoma Non-small Cell Lung Cancer

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.

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Study Type : Observational
Estimated Enrollment : 1539 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: BESPOKE Study of ctDNA Guided Immunotherapy
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy [ Time Frame: 2 years ]
    Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result


Secondary Outcome Measures :
  1. To determine progression free survival according to ctDNA change [ Time Frame: 2 years ]
    Compare progression free survival, defined as the duration of time between enrollment and an increase in severity of disease as determined by patient's treating physician, between groups determined by change in ctDNA

  2. Determine overall survival according to ctDNA change [ Time Frame: 2 years ]
    Compare overall survival, defined as the duration of time between enrollment and death for any reason, between groups determined by change in ctDNA

  3. Determine response rate according to ctDNA change in cases with progression of disease on first or second tumor assessment and who continue treatment. [ Time Frame: 2 years ]
    Compare percentage of patients that experience partial or complete response during the study, between groups determined by change in ctDNA

  4. To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment. [ Time Frame: 2 years ]
    Compare progression free survival between groups determined by change in ctDNA

  5. To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response. [ Time Frame: 2 years ]
    Compare duration of response, defined as the length of time from initial response to disease progression, between groups determined by change in ctDNA

  6. To determine percentage of patients with at least 6 months of durable clinical response according to ctDNA change in patients who achieve at least partial response on best tumor assessment. [ Time Frame: 2 years ]
    Among all patients that are clinically identified to experience partial or complete response, percentage that have at least 6 months durable clinical response as determined by ctDNA change

  7. Determine the impact of SIGNATERA on the confidence in immunotherapy treatment decisions based on the number of patients in which treating physician reports SIGNATERA made them more confident in immunotherapy treatment regimen [ Time Frame: 2 years ]
    Percent of patients whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen

  8. Determine the impact of SIGNATERA in informing immunotherapy treatment decisions [ Time Frame: 2 years ]
    Percent of patients whose immunotherapy treatment regimen was changed as a result of SIGNATERA and/or whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen

  9. Determine the impact of SIGNATERA on patient reported outcomes [ Time Frame: 2 years ]

    Assess patient anxiety levels and wellbeing in patients receiving SIGNATERA ctDNA test results.

    Patient responses to patient reported outcome questionnaires:

    EORTC QLQ-C30

    Assess if SIGNATERA makes patients feel that they are receiving the right treatment and determine if patients will continue to use Signatera in the future to monitor their cancer.



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have been diagnosed with advanced colorectal cancer, non-small cell lung cancer, or melanoma
Criteria

Prospective 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

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 blood donation, such as bleeding disorder
  4. Serious medical condition that may adversely affect ability to participate in the study
  5. Has initiated Immunotherapy

Control Arm 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

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 blood donation, such as bleeding disorder
  4. Serious medical condition that may adversely affect ability to participate in the study
  5. Has initiated Immunotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761783


Contacts
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Contact: Sarah Saywer 650-249-9091 bespokeiostudy@natera.com

Sponsors and Collaborators
Natera, Inc.
Investigators
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Principal Investigator: Alexey Aleshin, MD Natera, Inc.
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Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT04761783    
Other Study ID Numbers: 20-043-NCP
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natera, Inc.:
BESPOKE
circulating tumor DNA
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases