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Clinical Trial 19581
Cancer Type: Gastrointestinal Tumor
Interventions:BAY 73-4506 (Regorafenib); BMS-936558 (Nivolumab); Nivolumab; Regorafenib (Stivarga)
Study Type: Treatment
Phase of Study: Phase I
Investigators:
- Dae Won Kim
Study Title
Phase I study of Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer
Summary
Objective
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.