Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumours

Official Title

A Phase 1, Multi-centre, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumours That Are Amenable to Direct Injection

Summary:

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

Trial Description

Primary Outcome:

• Subject incidence of DLT

Secondary Outcome:

• Subject incidence of adverse events.
• Subject incidence of laboratory abnormalities
• Overall Response Rate (ORR)
• Duration of Response (DOR)
• Time to Response (TTR)
• Time to Progression (TTP)
• Progression-free Survival (PFS)
• Overall Survival (OS)

This is a phase 1, multicentre, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumours 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.

View this trial on ClinicalTrials.gov