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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
-

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Phase 2
Completed
Conditions
Melanoma
Interventions
First Posted Date
2019-08-28
Last Posted Date
2025-01-07
Lead Sponsor
Amgen
Target Recruit Count
72
Registration Number
NCT04068181
Locations
🇺🇸

New York Oncology Hematology, PC, Albany, New York, United States

🇺🇸

United States Oncology Regulatory Affairs Corporate Office, The Woodlands, Texas, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

and more 43 locations

Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma

Phase 2
Conditions
Kaposi Sarcoma
Interventions
First Posted Date
2019-08-22
Last Posted Date
2022-06-10
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
20
Registration Number
NCT04065152
Locations
🇫🇷

Service de Dermatologie Hopital Saint-Louis, Paris, France

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

Phase 2
Active, not recruiting
Conditions
Anaplastic Large Cell Lymphoma, ALK-Negative
Anaplastic Large Cell Lymphoma, ALK-Positive
Apocrine Carcinoma
Carcinoma Arising From Cylindroma
Carcinoma Arising From Spiradenoma
Digital Papillary Adenocarcinoma
Endocrine Mucin-Producing Sweat Gland Carcinoma
Extramammary Paget Disease
Extraocular Sebaceous Carcinoma
Hidradenocarcinoma
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
2025-01-08
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
First Posted Date
2016-11-17
Last Posted Date
2024-12-27
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
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