a trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy pexa-vec with the pd-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a study to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy pexa-vec with the pd-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * histological/cytological diagnosis of primary hcc, excluding cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma * advanced stage hcc per easl-eortc (european association for the study of the liver-european organisation for research and treatment of cancer) guidelines, i.e. patients who are not candidates for curative interventions and not candidates for locoregional modalities * patients naïve to systemic therapy for hcc * tumor status (as determined by radiology evaluation): at least one measurable viable tumor in the liver, ≥1 cm longest diameter (ld), using a dynamic imaging technique (arterial phase of triphasic computerized tomography \[ct\] scan, or dynamic contrast-enhanced magnetic resonance imaging \[mri\]), and injectable under imaging-guidance (ct or ultrasound) * at least one tumor that has not received prior local-regional treatment, or that has exhibited definitive growth of viable tumor since prior local-regional treatment of hcc undertaken at least 4 weeks prior to enrolment or 3 months prior to enrolment for radioembolization * child-pugh class a. note: paracentesis, albumin infusion or diuretic treatment cannot be used to downgrade child-pugh score (e.g., to improve from severe to moderate/mild or from moderate to mild ascites) * performance status 0 or 1 on the eastern cooperative oncology group (ecog) scale * adequate hematological, hepatic, and renal function * additional inclusion criteria exist exclusion criteria: * histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma * symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months * current or past history of cardiovascular disease (e.g., past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation * history of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening; patients with adequately treated esophageal varices are allowed * active, known or suspected significant immunodeficiency due to underlying illness including hiv/aids, autoimmune diseases, and/or immune-suppressive medication including high-dose corticosteroids * history of severe eczema and/or ongoing severe inflammatory skin condition (as determined by the investigator) requiring medical treatment * any known allergy or reaction to any component of nivolumab formulation or its excipients * additional exclusion criteria exist