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Talimogene laherparepvec

Generic Name
Talimogene laherparepvec
Brand Names
Imlygic
Drug Type
Biotech
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

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

Early Phase 1
Recruiting
Conditions
Soft Tissue Sarcoma
Sarcoma,Soft Tissue
Interventions
Radiation: Neoadjuvant Radiation
Procedure: Surgery
First Posted Date
2024-10-28
Last Posted Date
2025-03-10
Lead Sponsor
John Rieth
Target Recruit Count
30
Registration Number
NCT06660810
Locations
🇺🇸

University of Iowa, Iowa City, Iowa, United States

TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Phase 1
Active, not recruiting
Conditions
Soft Tissue Sarcoma
Interventions
Radiation: Radiotherapy
First Posted Date
2020-10-22
Last Posted Date
2025-01-24
Lead Sponsor
John Rieth
Target Recruit Count
8
Registration Number
NCT04599062
Locations
🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Neoadjuvant T-VEC in High Risk Early Melanoma

Phase 2
Suspended
Conditions
Melanoma
Interventions
First Posted Date
2020-06-11
Last Posted Date
2023-09-15
Lead Sponsor
University of California, Davis
Target Recruit Count
6
Registration Number
NCT04427306
Locations
🇺🇸

UC Davis Comprehensive Cancer Center, Sacramento, California, United States

Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease

Phase 2
Completed
Conditions
Melanoma Stage III
Melanoma Stage IV
Interventions
First Posted Date
2020-04-01
Last Posted Date
2025-03-12
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
24
Registration Number
NCT04330430
Locations
🇳🇱

Antoni van Leeuwenhoek ziekenhuis, Amsterdam, NH, Netherlands

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

Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma

Phase 2
Terminated
Conditions
Angiosarcoma of Skin
Interventions
First Posted Date
2019-04-19
Last Posted Date
2022-11-01
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
5
Registration Number
NCT03921073
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Phase 2
Recruiting
Conditions
Cutaneous Melanoma
Interventions
First Posted Date
2019-02-15
Last Posted Date
2024-05-02
Lead Sponsor
University of Louisville
Target Recruit Count
28
Registration Number
NCT03842943
Locations
🇺🇸

University of Louisville, Louisville, Kentucky, United States

Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies

Phase 1
Completed
Conditions
Peritoneal Surface Malignancy
Interventions
First Posted Date
2018-09-10
Last Posted Date
2024-11-20
Lead Sponsor
Dan Blazer III, M.D.
Target Recruit Count
28
Registration Number
NCT03663712
Locations
🇺🇸

University of Illinois College of Medicine at Chicago, Chicago, Illinois, United States

🇺🇸

Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Phase 1
Completed
Conditions
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Invasive Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
HER2/Neu Negative
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IV Breast Cancer AJCC v8
Interventions
First Posted Date
2018-06-12
Last Posted Date
2025-05-21
Lead Sponsor
University of California, San Francisco
Target Recruit Count
20
Registration Number
NCT03554044
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

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