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.
