IMLYGIC™

Generic Name: talimogene laherparepvec
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
001-01Breast adenocarcinoma, melanoma or epithelial cancer of the head and neck; gastrointestinal and vulval tumors.1First Administration To Man Of An Oncolytic Herpesvirus-1 Vector Containing A Transgene For Granulocyte Macrophage Colony Stimulating Factor (OncoVEX GM-CSF): AStudy of Its Safety, Distribution And Biological Activity
002-03CANCER - MELANOMA2

A Phase 2 Study of the Efficacy, Safety and Immunogenicity of OncoVEXGM-CSF in Patients with Stage IIIc and Stage IV Malignant Melanoma

002-03-ECANCER - MELANOMA2

An Extension Protocol for the Extended Use of OncoVEXGM-CSF for Eligible Patients Participating in Study 002-03: A Phase 2 Study of the Efficacy, Safety and Immunogenicity of OncoVEXGM-CSF in Patients with Stage IIIc and Stage IV Malignant Melanoma

004-04Treatment of Locally Advanced Epithelial Cancer of the Head and Neck1/2

An Exploratory Study of the Safety and Biological Activity of OncoVEXGM-CSF in Combination with Radiotherapy and Cisplatin in the Treatment of Locally Advanced Epithelial Cancer of the Head and Neck

005-04CANCER - PANCREAS1

Targeted Delivery of OncoVEXGM-CSF by Endoscopic Ultrasound (EUS)-Guided Fine Needle Injection (FNI) in Patients with Irresectable Pancreatic Cancer: A Pilot Multinational Experiment on Safety and Proof of Concept

005/05CANCER - MELANOMA3

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients with Unresectable Stage IIIb, IIIc, and IV Disease

005/05ECANCER - MELANOMA3

An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEXGM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05

006-09CANCER - HEAD AND NECK3

A Phase 3 Randomized Trial of Concurrent Cisplatin and Radiotherapy With or Without OncoVexGM-CSF in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck