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

StatusActive, Not Recruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Study First Submitted
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.
Trial Details
NCT Number NCT07861347
Lead Sponsor Brigham and Women's Hospital
Collaborators: Food and Drug Administration (FDA)
Conditions
(from sponsor)		 Metastatic Colorectal Cancer (mCRC)
Related terms Colorectal Neoplasms
Enrollment 1,030 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov