Cervical dysplasia (high grade squamous intraepithelial lesion or HSIL) caused by HPV

Phase III

This study is currently recruiting patients.

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

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

NCT03185013

VGX-3100

For more information please go to the study protocol.



Vulvar neoplasia (high grade squamous intraepithelial lesion or HSIL) caused by HPV

Phase II

This study is not yet open for participant recruitment.

This phase 2, randomized, open label study will investigate the efficacy of VGX-3100 followed by electroporation (EP) with CELLECTRA® 2000 alone or in combination with imiquimod in participants with human papillomavirus (HPV)-16 and/or HPV-18 related high grade squamous intraepithelial lesion (HSIL) of the vulva.

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

NCT03180684

VGX-3100

For more information please go to the study protocol.



Head and neck cancer caused by HPV

Phase I/IIa

This study is ongoing, but not recruiting participants.

This is a phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine (VGX-3100 and INO-9012) delivered by electroporation to subjects with HPV 16 and HPV 18 associated head and neck squamous cell cancer.

Prospective Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)

NCT02163057
HPV-005

INO-3112 (VGX-3100 and INO-9012)

For more information please go to the study protocol.




Cervical cancer caused by HPV

Phase I/IIa

This study is ongoing, but not recruiting participants.

This is an open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine (VGX-3100 and INO-9012) delivered by electroporation to female subjects with HPV 16 or 18 positive cervical carcinoma.

Phase I/IIA, Open-Label, Safety, Tolerability, and Immunogenicity Study of INO-3112 Delivered by Electroporation (EP) in Women With Cervical Cancer After Chemoradiation for Newly Diagnosed Disease or Therapy for Recurrent and/or Persistent Disease

NCT02172911
HPV-004 Clinical Research Study

INO-3112 (VGX-3100 and INO-9012)

For more information please go to the study protocol.




Aerodigestive cancer caused by HPV

Phase I

This study is currently recruiting participants.

This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.

A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies

NCT02241369
HPV-006 Clinical Research Study

INO-3106 + INO-9012

For more information please go to the study protocol.




Multiple solid tumors (Breast, lung, pancreatic, head and neck, ovarian, colorectal, gastric and esophageal, hepatocellular)

Phase I

This study is currently recruiting participants.

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

A Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy

NCT02960594

INO-1400

For more information please go to the study protocol.




Prostate cancer

Phase I

This study is ongoing, but not recruiting participants.

Evaluate the safety, tolerability and immunogenicity of INO-5150 alone or in combination with INO-9012, Inovio’s DNA-based IL-12 immune activator, when delivered intramuscularly followed by electroporation in men with biochemically relapsed prostate cancer. The study is also evaluating changes in PSA levels, an important biomarker in prostate cancer.

Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed (PSA) Prostate Cancer

NCT02514213 

INO-5150

For more information please go to the study protocol.