15
Participants
Start Date
August 16, 2017
Primary Completion Date
January 17, 2022
Study Completion Date
November 29, 2022
Talimogene Laherparepvec
Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10\^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10\^8 PFU/mL (or up to 4.0 mL of 10\^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL (or up to 4.0 mL of 10\^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.
Universitaets-Kinderspital beider Basel, Basel
Universitaets-Kinderspital, Zurich
Universitair Ziekenhuis Gent, Ghent
Columbia University Medical Center, New York
Centre Hospitalier Universitaire de Marseille - Hopital de la Timone, Marseille
Childrens Hospital of Philidelphia, Philadelphia
AI Dupont Hospital for Children, Wilmington
Hospital Universitario Infantil Niño Jesus, Madrid
Nemours du Pont Hospital in Florida, Jacksonville
Hospital Universitario Virgen del Rocio, Seville
Nationwide Childrens Hospital, Columbus
Cincinnati Childrens Hospital Medical Center, Cincinnati
Hospital Universitari i Politecnic La Fe, Valencia
Riley Hospital for Children, Indianapolis
Childrens Hospital of Michigan, Detroit
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago
Institut Hematologie et Oncologie Pediatrique, Lyon
Institut Curie, Paris
Centre Hospitalier Universitaire Sainte Justine, Montreal
IRCCS Ospedale Pediatrico Bambino, Roma
Hospital Universitari Vall d Hebron, Barcelona
Hospital Sant Joan de Deu, Esplugues de Llobregat
Lead Sponsor
Amgen
INDUSTRY