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ACTIVE NOT RECRUITING
NCT07861347

Emulation of the KEYNOTE177 Trial Using Specialty Oncology Electronic Health Records Databases

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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). 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1030

Start Date

2026-08-13

Completion Date

2026-11-13

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

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.

DRUG

5-fluorouracil-based chemotherapy

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.

Locations (1)

Brigham and Women's Hospital

Somerville, Massachusetts, United States