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An Open-Label Study of Regorafenib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Hepatocellular Carcinoma (HCC) after PD1/PD-L1 Immune Checkpoint Inhibitors
The purpose of this study is to look at how well the combination of Regorafenib and Pembrolizumab works in participants with advanced or metastatic hepatocellular carcinoma.
Primary: - To demonstrate the objective anti-tumor activity of regorafenib in combination with pembrolizumab as 2L treatment for advanced HCC Secondary: - To evaluate other measures of anti-tumor activity of regorafenib in combination with pembrolizumab as 2L treatment for advanced HCC - To evaluate safety and tolerability of regorafenib in combination with pembrolizumab Tertiary/Exploratory: - To establish further exploratory indicators of efficacy of regorafenib in combination with pembrolizumab - To evaluate the PK of regorafenib when concomitantly administered with pembrolizumab - To evaluate PK and immunogenicity of pembrolizumab when concomitantly administered with regorafenib - To identify biomarkers in baseline tumor materials and/or blood that may associate with response - To explore pharmacodynamic effects of regorafenib and pembrolizumab combination - To evaluate the PK/pharmacodynamic relationship for correlative biomarkers in blood such as peripheral lymphocytes, circulating proteins or nucleic acids (DNA or RNA), and/or tissues as well as measures of safety and/or efficacy - To further investigate the study intervention and similar drugs (i.e., mode-of-action-related effects and/or safety) and to further investigate pathomechanisms deemed relevant to cancer and associated health problems
BAY 73-4506 (Regorafenib); Pembrolizumab (Keytruda); Regorafenib (Stivarga)
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