A Phase I, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec (T-VEC) injected into liver tumors

Introduction T-VEC, an intralesionally-delivered oncolytic immunotherapy, is a herpes simplex virus-1 engineered to selectively replicate in tumors and stimulate an antitumor immune response through expression of GMCSF. T-VEC has the ability to lyse various cancer cell types in vitro[1]. A Phase III study of T-VEC injected into skin, subcutaneous, or lymph node tumors versus subcutaneous GM-CSF in advanced melanoma demonstrated improved durable response rate for T-VEC, with regression of both injected and uninjected lesions[2]. To further explore if different types of cancers and locations might be treatable with T-VEC, this Phase I study evaluates whether primary and metastatic liver tumors may be safely and effectively injected with T-VEC.