NCT07861347Active, not recruiting
Emulation of the KEYNOTE177 Trial Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1030 (actual)
- First submitted
- 29 Sept 2026
- Start date
- 13 Aug 2026
- Primary completion date
- 13 Nov 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07861347
What you commit to
- Study type: Observational
- Participants enrolled: 1030
- From 13 Aug 2026 to the primary completion date, 13 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior immune checkpoint inhibitor treatment.
Other illness
- Active autoimmune disease requiring systemic treatment within 2 years before study regimen initiation.
- Another primary malignancy within 5 years before study regimen initiation, except nonmelanoma skin cancer or cervical carcinoma in situ.
Other
- Known active central nervous system or meningeal metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.