Metastatic Colorectal Cancer (mCRC)NCT07861347
Emulation of the KEYNOTE177 Trial Using Specialty Oncology Electronic Health Records Databases
An observational study of Metastatic Colorectal Cancer (mCRC), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This observational trial emulation aims to reproduce the KEYNOTE-177 trial (NCT02563002) using real-world specialty oncology electronic health record data and to assess the concordance between the original and emulated treatment effect estimates for overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- Pembrolizumab and 5-fluorouracil-based chemotherapy
- How many people
- 1,030 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 13 Nov 2026
- Phase
- Observational
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: Adults with metastatic colorectal cancer who initiated first-line pembrolizumab or 5-fluorouracil-based chemotherapy.
Who may be able to join
- Age 18 years or older at first-line study regimen initiation.
- Metastatic colorectal cancer documented in a specialty oncology electronic health record.
- Initiation of pembrolizumab or 5-fluorouracil-based chemotherapy, with or without bevacizumab or cetuximab, as first-line treatment for metastatic disease.
- Confirmed dMMR or MSI-H status for chemotherapy initiators; pembrolizumab initiators were presumed to have dMMR or MSI-H disease based on the treatment indication.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 when ascertainable in the database.
Who cannot join
- Prior systemic treatment for metastatic colorectal cancer.
- Chemotherapy within 6 months before study regimen initiation.
- Use of an investigational agent within 4 weeks before study regimen initiation.
- Active autoimmune disease requiring systemic treatment within 2 years before study regimen initiation.
- Known active central nervous system or meningeal metastases.
- Prior immune checkpoint inhibitor treatment.
- Another primary malignancy within 5 years before study regimen initiation, except nonmelanoma skin cancer or cervical carcinoma in situ.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Somerville, Massachusetts, 02145
About this study
This observational trial emulation aims to reproduce the KEYNOTE-177 trial (NCT02563002) using real-world specialty oncology electronic health record data and to assess the concordance between the original and emulated treatment effect estimates for overall survival (OS). KEYNOTE-177 was a phase III, open-label, randomized trial comparing first-line pembrolizumab with 5-fluorouracil-based chemotherapy, with or without bevacizumab or cetuximab, in patients with MSI-H or dMMR metastatic colorectal cancer.
Read the detailed description
Randomized controlled trials (RCTs) are generally regarded as the gold standard for establishing the efficacy of medical products. Real-world data (RWD) can complement evidence from RCTs, but valid non-interventional oncology studies require suitable data, study designs, and analysis methods. Building on the RCT DUPLICATE initiative, the EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) project aims to emulate 12 randomized oncology trials using multiple electronic health record data sources.
The purpose of this protocol is to describe the emulation of KEYNOTE-177 (NCT02563002). KEYNOTE-177 was a phase III, open-label, randomized trial comparing first-line pembrolizumab with 5-fluorouracil-based chemotherapy, with or without bevacizumab or cetuximab, in patients with MSI-H or dMMR metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- Pembrolizumab, 5-fluorouracil-based chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Observed initiation of first-line pembrolizumab for MSI-H or dMMR metastatic colorectal cancer in routine care. Treatment was not assigned by this observational study.
5-fluorouracil-based chemotherapyDrug
Observed initiation of first-line 5-fluorouracil-based chemotherapy, with or without bevacizumab or cetuximab, for MSI-H or dMMR metastatic colorectal cancer in routine care. Treatment was not assigned by this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Initiation of pembrolizumab | Not described Receives: Drug: Pembrolizumab | |
| Initiation of 5-fluorouracil-based chemotherapy | Not described Receives: Drug: 5-fluorouracil-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause mortality (overall survival)
Hazard ratio (95% CI)
Measured: From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on the oncology registry data provider; end of data ranges from September 2023 to February 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start13 Aug 2026
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
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 Brigham and Women's HospitalThe 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
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley V Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861347
- Sponsor's protocol ID
- 2022P002556-ENC-KEYNOTE177
- Other IDs
- 75F40122C00181
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No