Last updated on December 2019

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors


Brief description of study

This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection

Detailed Study Description

This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical setting. Approximately 18 -27 treated pediatric subjects are expected to be enrolled into 2 cohorts stratified by age (permissible based on the incidence of DLTs, a minimum of 6 subjects/cohort and a minimum of 18 subjects total). DLT will be evaluated based on 6 to 12 DLT-evaluable subjects in each cohort. The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.

Clinical Study Identifier: NCT02756845

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