Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination with REGN2810 in Subjects with Newly-Diagnosed Glioblastoma (GBM)

  • STATUS
    Recruiting
  • participants needed
    20
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Updated on 19 February 2024

Summary

The purpose of this clinical study is to evaluate safety of the study treatment, its effects on the immune system and on GBM. The study treatment includes three experimental parts: 

Two experimental products, INO-5401 + INO-9012, will be delivered into your muscle by an electroporation device called CELLECTRA® 2000.
The third experimental study treatment is called cemiplimab (also called REGN2810). Cemiplimab is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC), but is not approved by any regulatory agency for the treatment of any other cancer or disease. 
Cemiplimab investigational product is currently being studied in patients with cancer in other clinical studies. This is a clinical study which involves research. The three experimental products are not approved by the FDA for the treatment of GBM. INO-5401 + INO 9012 is a DNA based therapy that has been created in a lab using the DNA sequence for genes of interest. Genes are the pieces of DNA that act as instructions to make specific proteins that are important for the makeup or function of a cell. They also instruct the cells to make specific proteins that may help your immune system to react against cancer cells. INO-5401 plasmids have code for three proteins which are similar to proteins commonly present on cancer cells. This may help your immune system to help fight your cancer. CELLECTRA® 2000 is a device that will deliver small electric charges to help the entry of the plasmids into your muscle cells. 
Cemiplimab is a monoclonal antibody (protein) designed to attach to a protein called PD1. PD-1 appears on tumor cells and tumor-infiltrating immune cells, and can be used by the tumor to 'hide' from your immune system. By blocking PD-1, cemiplimab may help your immune system to attack the cancer. 
The usual way to treat GBM is to have surgery to remove the tumor followed by radiation therapy. Some patients may also receive a chemotherapy pill called temozolomide. 

Description

In addition to the study treatment, everyone in the study will receive radiation therapy and temozolomide. In this study, radiation will be given for three weeks instead of the standard 6 weeks

FAQ


Details
Condition Glioblastoma,oncology,cancer
Age 18years - 99years
Clinical Study Identifier03491683
Last Modified on19 February 2024

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