Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

  • STATUS
    Not Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    28
  • sponsor
    University of Arizona
Updated on 14 September 2022
platelet count
cancer
serum pregnancy test
carcinoma
anticoagulants
growth factor
skin cancer
squamous cell carcinoma
serum bilirubin
anticoagulant therapy
neutrophil count
thromboplastin
hematopoietic growth factor

Summary

This is single arm a Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

Description

The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging when patients have: multiple SCCs on their body, when the SCC is on a challenging place on the body to remove or when patients are older or have diseases that place them at risk for surgery related complications. Immune therapy is a treatment that uses certain parts of a person's immune system to fight disease. Immune therapy is a proven therapeutic approach in many cancers, including melanoma, another type of skin cancer.

Talimogene laherparepvec (TVEC) is made from a modified herpes simplex virus type 1 (HSV-1, the "cold sore" virus). The virus' genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF), which multiplies and grows in tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat patients with white blood cell counts that are too low. This modified HSV-1 produces a protein that acts on tumor cells and stimulates the immune system. TVEC is administered by injection with a needle directly into one or more tumors and works by directly destroying cancer cells and enhancing immune response to destroy cancer cells.

Details
Condition Squamous Cell Carcinoma, Skin Cancer, Keratoacanthoma, Cutaneous Tumor, Skin Cancer, Squamous Cell, Lesion Skin
Treatment Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection, Injection of TVEC into target lesions 2wks after 2nd injection, Injection of TVEC into target lesions 2wks after 3rd injection
Clinical Study IdentifierNCT03714828
SponsorUniversity of Arizona
Last Modified on14 September 2022

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