Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)

Human Papillomavirus (HPV) Clinical Trial

Official title:
A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva

Status Completed

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) [vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma in Situ
Carcinoma, Squamous Cell
Human Papillomavirus (HPV)
Pre-cancerous Lesions of the Vulva
Squamous Intraepithelial Lesions of the Cervix
VIN2
VIN3
Vulvar Dysplasia
Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)
Vulvar Intraepithelial Neoplasia (VIN)

Clinical Trial Details

NCT number	NCT03180684
Study type	Interventional
Source	Inovio Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	August 31, 2017
Completion date	December 18, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02540928` - AMG 319 in HPV Positive and Negative HNSCC	Phase 2
Not yet recruiting	`NCT05727033` - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections	N/A
Completed	`NCT03111251` - Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics	N/A
Withdrawn	`NCT04849377` - RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC	Phase 2
Completed	`NCT02873741` - New Strategies to Assess Anal Cancer Risk In Women
Completed	`NCT01188850` - Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100	Phase 1
Completed	`NCT02524223` - Prevalence of HPV Transmission During Medically Assisted Procreation Procedures	N/A
Recruiting	`NCT01197079` - Utilization of Human Papillomavirus (HPV) Vaccine Among Young Men Who Have Sex With Men (MSM) and Parents of Boys (Aged 9 to 18 Years)	N/A
Recruiting	`NCT05539638` - The Role of Circulating Tumour DNA in Head and Neck Cancer