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

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.