Colorectal CancerNCT04761783
BESPOKE Study of ctDNA Guided Immunotherapy
An observational study of Colorectal Cancer and Melanoma, run by Natera, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Melanoma, Non-small Cell Lung Cancer
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with advanced colorectal cancer, non-small cell lung cancer, or melanoma
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- BESPOKE, circulating tumor DNA
- Medical subject headings
- Colorectal Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (9)
To determine progression free survival according to ctDNA change
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
Measured: 2 years
Determine overall survival according to ctDNA change
Compare overall survival, defined as the duration of time between enrollment and death for any reason, between groups determined by change in ctDNA
Measured: 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.
Compare percentage of patients that experience partial or complete response during the study, between groups determined by change in ctDNA
Measured: 2 years
To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment.
Compare progression free survival between groups determined by change in ctDNA
Measured: 2 years
To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response.
Compare duration of response, defined as the length of time from initial response to disease progression, between groups determined by change in ctDNA
Measured: 2 years
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.
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
Measured: 2 years
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
Percent of patients whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen
Measured: 2 years
Determine the impact of SIGNATERA in informing immunotherapy treatment decisions
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
Measured: 2 years
Determine the impact of SIGNATERA on patient reported outcomes
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start28 May 2021
- Primary completion31 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Aleshin, MD, Principal investigator, Natera, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761783
- Sponsor's protocol ID
- 20-043-NCP
- Status last verified
- Aug 2024
- First submitted
- 16 Feb 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35636789
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BESPOKE Study of ctDNA Guided Immunotherapy
- ClinicalTrials.gov ID
- NCT04761783
- Acronym / sponsor ID
- 20-043-NCP
- Conditions
- Colorectal Cancer, Melanoma, Non-small Cell Lung Cancer
- Keywords
- BESPOKE, circulating tumor DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with advanced colorectal cancer, non-small cell lung cancer, or melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
To determine progression free survival according to ctDNA change
Time frame: 2 years
Determine overall survival according to ctDNA change
Time frame: 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.
Time frame: 2 years
To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment.
Time frame: 2 years
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
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
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
Determine the impact of SIGNATERA in informing immunotherapy treatment decisions
Time frame: 2 years
Determine the impact of SIGNATERA on patient reported outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 35636789Kasi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Aleshin, MD principal investigator
Natera, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Melanoma, run by Natera, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.