RecruitMe Clinical Trial

HPV-303: REVEAL 2: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VGX-3100 DELIVERED INTRAMUSCULARLY FOLLOWED BY ELECTROPORATION WITH CELLECTRA 5PSP FOR THE TREATMENT OF HPV-16 AND/OR HPV-18 RELATED HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION (HSIL) OF THE CERVIX
VGX-3100 Followed by Electroporation with Cellectra for HPV-related High-Grade Squamous Intraepithelial Lesion of Cervix (REVEAL 2)
Sponsor:Inovio Pharmaceuticals
Enrolling:Female Patients Only
Minimum Age:18 years old
IRB Number:AAAS2854
U.S. Government ID:NCT03721978
Contact: Reena Vattakalam: 212-342-6895 / rmv2110@cumc.columbia.edu
Additional Study Information:

The purpose of this study, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device, CELLECTRA 5PSP, that delivers a small electric charge through 5 needles to increase the amount of the study drug taken up by muscle. The treatment combination is experimental, which means it has not been approved by U.S Food and Drug Administration (FDA). The study drug and device combination has been tested in two previous studies on women with grade 2 or 3 pre-cancerous cells on the cervix and no serious problems were noted. At least five other studies have been started in humans to deliver other drugs using the same study device that will be used in this study without serious problems. The study will look at the effects of VGX-3100, which will be given into the deltoid muscle (shoulder muscle) or quadriceps muscle (thigh muscle) as an alternate option at a dose of 6 mg of DNA plasmid three separate times to see if it helps clear or shrink cervical lesions in women with grade 2 or 3 precancerous cells on the cervix by making the bodys immune response to HPV stronger. In this research study we are examining how to activate your immune system with VGX-3100 by using DNA- based therapy. DNA-based therapy involves inserting VGX-3100 into your shoulder muscle or thigh muscle as an alternate option. The DNA instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell.

Do You Qualify?
Are you HPV positive?YesNo
Do you have a lesion on your cervix?YesNo
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Who Can I Contact?
For more information, please contact:
Reena Vattakalam
Email: rmv2110@cumc.columbia.edu
Phone: 212-342-6895