Treatment group information was blinded after randomization. In the nivolumab plus ipilimumab cohort, patients were randomized between January 4 and September 26, 2016. Objective To assess efficacy and safety of nivolumab plus ipilimumab in patients with advanced HCC who were previously treated with sorafenib.ĭesign, Setting, and Participants CheckMate 040 is a multicenter, open-label, multicohort, phase 1/2 study. Combining nivolumab with ipilimumab may improve clinical outcomes compared with nivolumab monotherapy. Importance Most patients with hepatocellular carcinoma (HCC) are diagnosed with advanced disease not eligible for potentially curative therapies therefore, new treatment options are needed. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.Time to Onset (Median, Range ) and Time to Resolution (Median, Range ) of Immune-Mediated Adverse Events by Treatment Arm Waterfall Plots of Percentage Change in Tumor Burden From Baseline by Treatment ArmĮFigure 4. Spider Plots of Change in Tumor Burden From Baseline by Treatment ArmĮFigure 3. Time to Response and Duration of Response by Treatment ArmĮFigure 2. Summary of Patients With an Any-Grade Immune-Mediated Adverse Event Rechallenged With Nivolumab or IpilimumabĮFigure 1. Treatment-Related Adverse Events by Baseline Disease EtiologyĮTable 8. Treatment-Related and Immune-Mediated Adverse EventsĮTable 7. Objective Response Rate, Best Overall Response, and Disease Control Rate for All PatientsĮTable 6. ![]() Efficacy by Baseline Hepatocellular Carcinoma (HCC) Etiology and PD-L1 StatusĮTable 5. Observed Objective Response Rate with Exact 95% CI and 90% Lower BoundĮTable 3.
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