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)

Inovio Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Vulvar Dysplasia; VIN2; VIN3; Pre-cancerous Lesions of the Vulva; Human Papillomavirus (HPV); Vulvar Intraepithelial Neoplasia (VIN); Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)

Treatments: Device: CELLECTRA™ 2000; Drug: Imiquimod 5% Cream; Biological: VGX-3100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03180684

HPV-201

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 and above;
• Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;

Exclusion criteria

• Biopsy-proven differentiated VIN;
• Any previous treatment for vulvar HSIL within 4 weeks prior to screening;
• Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
• Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product;
• Immunosuppression as a result of underlying illness or treatment;
• Significant acute or chronic medical illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

VGX-3100 + EP

Experimental group

Description:

Participants with histologically confirmed vulvar high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV) 16 and/or 18, received four doses of 6 mg VGX-3100 as an intramuscular (IM) injection on Day 0, Week 4, Week 12, and Week 24 followed by electroporation (EP) using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.

Treatment:

Device: CELLECTRA™ 2000

Biological: VGX-3100

VGX-3100 + EP + Imiquimod

Experimental group

Description:

Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.

Treatment:

Device: CELLECTRA™ 2000

Drug: Imiquimod 5% Cream

Biological: VGX-3100