drugset / Trial / NCT03823131

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

NCT03823131

Non-randomizedSequentialOpen-labelTreatment

Summary

This phase II trial studies how well tavokinogene telseplasmid with electroporation (tavo-EP), pembrolizumab, and epacadostat work in treating patients with squamous cell carcinoma of the head and neck that cannot be removed by surgery. Tavokinogene telseplasmid with electroporation is a gene therapy that may delay of tumor growth and which may have less toxicity than other methods of gene delivery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tavokinogene telseplasmid with electroporation, pembrolizumab, and epacadostat may work better in treating squamous cell carcinoma of the head and neck.

Timeline

Start
2019-05-02
Primary completion
2022-07-31
Completion
2022-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CORVax Vaccine 0.8 mg Intrathecal
Subject Epacadostat Small molecule Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Tavokinogene Telseplasmid Vaccine 20 ml Other