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Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Cancer Clinical Trial

Official title:
Prospective Study of HPV Specific Immunotherapy in Subjects With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)

Clinical Trial Summary

This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine delivered by electroporation (EP) to participants with human papilloma virus (HPV) associated head and neck squamous cell cancer (HNSCC).

Clinical Trial Description

This is a Phase I/IIa, open-label, study to evaluate the safety, tolerability, and immunogenicity of INO-3112 [6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding E6 and E7 proteins of HPV 16 and HPV 18) and 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12)] delivered by electroporation (EP) in up to 25 (twenty-five) participants with HPV positive head and neck cancer. The immunotherapy was studied in the following two groups of participants: 1. Participants who received immunotherapy before and after definitive surgery (Cohort I) 2. Participants who received immunotherapy at least 2 months after chemoradiation therapy (Cohort II). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02163057
Study type Interventional
Source Inovio Pharmaceuticals
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 13, 2014
Completion date January 23, 2017
View Details
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