Metastatic Colorectal Cancer (mCRC)NCT05420909
A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)
An observational study of Metastatic Colorectal Cancer (mCRC), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 1 Apr 2019
- 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: Participants who were diagnosed with mCRC and received 2L therapy of interest were selected from Flatiron Health's data from January 2013 through March 2019. 2L therapies of interest included: * FOLFIRI and bevacizumab * FOLFOX and bevacizumab * CAPEOX and bevacizumab * FOLFIRI and panitumumab * FOLFIRI and ziv-aflibercept * FOLFOX, bevacizumab and other (non I-O) * FOLFIRI, ziv-aflibercept and other (non I-O) * FOLFIRI, bevacizumab and other (non I-O) * Nivolumab monotherapy * Pembrolizumab monotherapy
Who may be able to join
- Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by:
- Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
- Pathology consistent with CRC
- At least two documented clinical visits on or after January 1, 2013
- Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
- Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR)
- Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date
- Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study
Who cannot join
- Participants <18 years of age at index date
- Participants who received clinical trial drug during the prior or post periods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142
The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Keywords
- mCRC, Checkmate-142, Nivolumab
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| Cohort 1 | Participants diagnosed with metastatic colorectal cancer (mCRC) selected from the Flatiron Electronic Health Record database |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 6 years
Duration of Systemic Treatment
Durations were reported for the first line of therapy prior to the second line (2L) therapy of interest, the 2L therapy of interest, the third line of therapy, and the at least fourth line of therapy.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start28 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420909
- Sponsor's protocol ID
- CA209-7AU
- Status last verified
- Aug 2022
- First submitted
- 13 Jun 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142
- ClinicalTrials.gov ID
- NCT05420909
- Acronym / sponsor ID
- CA209-7AU
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Keywords
- mCRC, Checkmate-142, Nivolumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 15 Jun 2022 (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.
The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants diagnosed with metastatic colorectal cancer (mCRC) selected from the Flatiron Electronic Health Record database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were diagnosed with mCRC and received 2L therapy of interest were selected from Flatiron Health's data from January 2013 through March 2019. 2L therapies of interest included: * FOLFIRI and bevacizumab * FOLFOX and bevacizumab * CAPEOX and bevacizumab * FOLFIRI and panitumumab * FOLFIRI and ziv-aflibercept * FOLFOX, bevacizumab and other (non I-O) * FOLFIRI, ziv-aflibercept and other (non I-O) * FOLFIRI, bevacizumab and other (non I-O) * Nivolumab monotherapy * Pembrolizumab monotherapy
Key inclusion criteria (8 listed)
- Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by:
- Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
- Pathology consistent with CRC
- At least two documented clinical visits on or after January 1, 2013
- Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
Key exclusion criteria (2 listed)
- Participants <18 years of age at index date
- Participants who received clinical trial drug during the prior or post periods
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
Overall Survival (OS)
Time frame: Up to 6 years
Duration of Systemic Treatment
Time frame: Up to 6 years
Durations were reported for the first line of therapy prior to the second line (2L) therapy of interest, the 2L therapy of interest, the third line of therapy, and the at least fourth line of therapy.
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 19 Aug 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Metastatic Colorectal Cancer (mCRC), run by Bristol-Myers Squibb 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?
The sponsor lists 8 inclusion and 2 exclusion criteria. 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 19 Aug 2022. 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?
Overall Survival (OS) (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2022.