Background: Immune-based approaches in colorectal cancer have been unsuccessful with the exception of immune checkpoint inhibition in microsatellite unstable disease. This may relate to advanced colorectal cancer being less immunogenic than other tumors, as evidenced by the lack of infiltrating lymphocytes. JX-594 (Pexa-Vec®) is a thymidine kinase gene-inactivated oncolytic vaccinia virus engineered for the expression of transgenes encoding human granulocyte- macrophage colony-stimulating factor and β-galactosidase. JX-594 has direct oncolytic activity and mediates tumor cell death via the induction of innate and adaptive immune responses. This study aims to enhance the anti-tumor immunity induced by JX-594 oncolytic viral therapy by administering the vaccine with immune checkpoint inhibition; the combination of tremelimumab (CTLA-4 antibody) and durvalumab (PD-L1 antibody). The primary objective was to establish the safety and tolerability of the treatment and the secondary objective to explore progression free survival.
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