The expansion phase of the CA209-040 study is seeking to recruit approximately 400 patients into three cohorts stratified by hepatitis viral status, with an estimated completion date of July 2018.2
Primary endpoints include the incidence of worst adverse events and clinical laboratory test abnormalities.
1. El-Khoueiry AB, Melero I, Crocenzi TS, et al. Phase I/II safety and antitumor activity of nivolumab in patients with advanced hepatocellular carcinoma (HCC): CA209-040. J Clin Oncol. 2015 (suppl; abstr LBA101).
2. NIH Clinical Trials Registry. www.ClinicalTrails.gov. Identifier: NCT01658878
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