Submitted by: Samuel Pacamparra 2017-07-11 00:00:00 Last Updated by: Samuel Pacamparra 2018-05-03 16:21:24 Export to PDF

An immunotherapy and a device used together to treat women with precancerous cells on the cervix caused by human papillomavirus (HPV)

PHRR170711-001612

HPV-301

2017-CT0395

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

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.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-03-07 22 2020-01-07 0000-00-00

Ongoing

Institution Classification Region LTO #
Inovio Pharmaceuticals, Inc. Private Business United States of America Not Applicable
Institution Classification Region LTO #
PPD Pharmaceutical Development Philippines Corporation Private Business NCR CDRR-NCR-CRO-22
Institution Amount Region
Inovio Pharmaceuticals, Inc. N/A United States of America
Name E-Mail Phone Number Postal Address
Prakash Bhuyan prakash.bhuyan@inovio.com 267-440-4255 660 W. Germantown Pike, Plymouth Meeting, PA, USA, 19462
Name E-Mail Phone Number Postal Address
Prakash Bhuyan prakash.bhuyan@inovio.com 267-440-4255 660 W. Germantown Pike, Plymouth Meeting, PA, USA, 19462
Name Expertise Affiliation
Concepcion Rayel, MD Internal Medicine Davao Doctors Hospital
Raymond Sulay, MD Internal Medicine Perpetual Succour Hospital
Project Location Institutional Ethics Review Board
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board

Conditions:
Cervical Dysplasia
Cervical High Grade Squamous Intraepithelial Lesion (HSIL)

Keywords:
Cervical intraepithelial neoplasia (CIN)
Human papillomavirus (HPV)
High grade squamous intraepithelial lesion (HSIL)
CIN 2
CIN 3
Papillomavirus

Percentage of Participants with No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36.

Mulltiple measures of safety including:
• - Number of Participants with Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment and for the Duration of the Study

Multiple measures of regression or viral clearance including:
• - Percentage of Participants with No Evidence of Cervical HSIL at Week 36
• - Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36
• - Percentage of Participants with No Evidence of Low Grade Squamous Intraepithelial Lesion (LSIL) or HSIL at Week 36
• - Percentage of Participants with No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18 at Week 36
• - Percentage of Participants with No Progression of Cervical HSIL to Cervical Carcinoma from Baseline to Week 36
• - Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations at Week 36

Multiple measures of immunogenicity assessment including:
• - Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
• - Change from Baseline in Interferon-Gamma Response Magnitude
• - Change from Baseline in Flow Cytometry Response Magnitude

Recruiting

  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czech Republic
  • Estonia
  • Finland
  • Germany
  • Italy
  • Lithuania
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Slovakia
  • South Africa
  • Spain
  • Thailand
  • United Kingdom
  • United States

Clinical Trial

20170216140247

2017-06-22

None

Inclusion criteria

• Women aged 18 years and above
• Confirmed cervical infection with HPV types 16 and/or 18 at screening
• Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
• Confirmed histologic evidence of cervical HSIL at screening
• Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
• With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
• Normal screening electrocardiogram (ECG)

Exclusion Criteria:
• Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
• Cervical lesion(s) that cannot be fully visualized on colposcopy
• History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
• Treatment for cervical HSIL within 4 weeks prior to screening
• Pregnant, breastfeeding or considering becoming pregnant during the study
• History of previous therapeutic HPV vaccination
• Immunosuppression as a result of underlying illness or treatment
• Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
• Receipt of any non-study, live vaccine within 4 weeks of Day 0
• Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
• Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
• Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
• Less than two acceptable sites available for IM injection

Interventional

VDX-3100 or placebo followed by electroporation (EP) using CELLECTRA™-5PSP device

Participants will be randomized  to receive three doses (Day 0, Week 4, Week 12) of either 6 mg (in 1 ml) VGX-3100 or placebo, each IM followed by EP, in a 2:1 ratio

Randomized

Double Blind

None

Not Applicable

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.

Phase III

5

Unspecified

No Difference

07 Mar 2018

Utilization Utilization Info
No records found.

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