Talimogene laherparepvec

Generic Name: Talimogene laherparepvec

Brand Names: Imlygic

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1187560-31-1

Unique Ingredient Identifier: 07730V90L6

Background: Talimogene laherparepvec is an oncolytic treatment used in local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma. It is a genetically administered herpes simplex virus 1 (HSV-1) that expresses human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with antitumor and immune-stimulating activities. It specifically replicates within tumor cells and causes lysis. It was approved by the FDA in 2015 under the market name Imlygic.

In general, talimogene laherparepvec has been modified so that it can infect and multiply inside melanoma cells . The drug subsequently uses the melanoma cells' own machinery to multiply, eventually overwhelming the melanoma cells and killing them . Alternatively, although talimogene laherparepvec also enters healthy cells, it is not designed to multiply inside them .

Indication: This medication is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable, cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery . Elsewhere, the EMA notes that the agent is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral diseases .

Associated Conditions: Unresectable Skin Lesion

Associated Therapies: -

Clinical Trials

Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma

Phase 1

Completed

Conditions: Unresectable Stage IIIB-IV Malignant Melanoma

Interventions: Drug: Talimogene laherparepvec

First Posted Date: 2017-02-27

Last Posted Date: 2023-08-09

Lead Sponsor: Amgen

Target Recruit Count: 18

Registration Number: NCT03064763

Locations: 🇯🇵
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
🇯🇵
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
🇯🇵
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

and more 6 locations

Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

Phase 2

Active, not recruiting

Conditions: Extramammary Paget Disease
NK-Cell Lymphoma, Unclassifiable
Porocarcinoma
Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Refractory Merkel Cell Carcinoma
Refractory Skin Squamous Cell Carcinoma
Adnexal Carcinoma
Recurrent T-Cell Non-Hodgkin Lymphoma
Refractory T-Cell Non-Hodgkin Lymphoma
Skin Basosquamous Cell Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Procedure: Positron Emission Mammography
Biological: Talimogene Laherparepvec

First Posted Date: 2016-12-01

Last Posted Date: 2024-12-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 68

Registration Number: NCT02978625

Locations: 🇺🇸
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

and more 33 locations

Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

Phase 2

Active, not recruiting

Conditions: Recurrent Melanoma
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Unresectable Melanoma
Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7
Stage IIIA Cutaneous Melanoma AJCC v7

Interventions: Biological: Pembrolizumab
Biological: Talimogene Laherparepvec

First Posted Date: 2016-11-17

Last Posted Date: 2024-11-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 43

Registration Number: NCT02965716

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
🇺🇸
CTCA at Western Regional Medical Center, Goodyear, Arizona, United States

and more 17 locations

Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery

Phase 2

Active, not recruiting

Conditions: Sarcoma G3
Stage II Soft Tissue Sarcoma AJCC v7
Soft Tissue Sarcoma of the Trunk and Extremities
Stage I Soft Tissue Sarcoma AJCC v7
Undifferentiated Pleomorphic Sarcoma
Sarcoma G2
Leiomyosarcoma
Liposarcoma
Soft Tissue Sarcoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Magnetic Resonance Imaging
Radiation: Radiation Therapy
Biological: Talimogene Laherparepvec

First Posted Date: 2016-10-05

Last Posted Date: 2024-11-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT02923778

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

and more 14 locations

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer
Ductal Carcinoma
Invasive Breast Carcinoma
Invasive Ductal Breast Carcinoma

Interventions: Biological: Talimogene laherparepvec
Drug: Paclitaxel

First Posted Date: 2016-05-20

Last Posted Date: 2024-12-20

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 50

Registration Number: NCT02779855

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

Phase 1

Completed

Conditions: Advanced Non CNS Tumors

Interventions: Drug: Talimogene Laherparepvec

First Posted Date: 2016-04-29

Last Posted Date: 2024-02-20

Lead Sponsor: Amgen

Target Recruit Count: 15

Registration Number: NCT02756845

Locations: 🇫🇷
Centre Hospitalier Universitaire de Marseille - Hopital de la Timone, Marseille cedex 5, France
🇺🇸
AI Dupont Hospital for Children, Wilmington, Delaware, United States
🇫🇷
Institut Hematologie et Oncologie Pediatrique, Lyon cedex 08, France

and more 19 locations

Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)

Phase 1

Completed

Conditions: Carcinoma of the Head and Neck

Interventions: Drug: Talimogene Laherparepvec
Biological: Pembrolizumab

First Posted Date: 2015-12-10

Last Posted Date: 2021-09-08

Lead Sponsor: Amgen

Target Recruit Count: 36

Registration Number: NCT02626000

Locations: 🇬🇧
Research Site, Wirral, United Kingdom

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

Phase 1

Completed

Conditions: Hepatocellular Carcinoma
Liver Tumors
Cutaneous or Subcutaneous Lymph Node
Liver Metastases

Interventions: Drug: Talimogene Laherparepvec
Drug: Pembrolizumab

First Posted Date: 2015-07-28

Last Posted Date: 2024-08-06

Lead Sponsor: Amgen

Target Recruit Count: 127

Registration Number: NCT02509507

Locations: 🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸
University of California Los Angeles, Santa Monica, California, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 29 locations