Clinical Trials Search
Phase I study of Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer
This is a phase I trial using the combination of nivolumab and regorafenib in refractory metastatic colorectal cancer. This will be a 3+3 design with 2 dose cohort.
Primary Objective To assess safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose level in the absence of establishing an MTD of regorafenib in combination with nivolumab in subjects with advanced, refractory colorectal cancers Secondary Objectives 1. To access response rate using RECIST criteria 2. To access overall survival 3. To further evaluate the frequency and severity of adverse events and tolerability of the combination regimen. Exploratory Objectives 1. To evaluate potential correlations between blood or tumor biomarkers and clinical outcome.
BAY 73-4506 (Regorafenib); BMS-936558 (Nivolumab); Nivolumab (); Regorafenib (Stivarga)