Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer

PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To evaluate the activity of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. II. To evaluate the safety and feasibility of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. TERTIARY/EXPLORATORY: I. To evaluate biomarkers associated with the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. OUTLINE: Patients receive celecoxib orally (PO) twice daily (BID) on days 1-28 of each cycle, durvalumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and tremelimumab IV over 30-60 minutes on day 1 of cycle 1 only. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Patients may undergo tissue biopsy during screening. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for up to 2 years.