REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:June 13, 2017
End Date:April 2021
Contact:Inovio Call Center
Email:clinical.trials@inovio.com
Phone:267-440-4237

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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.


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
We found this trial at
29
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Dr. Ault
Phone: 913-588-6287
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
Principal Investigator: Dr. Lederman
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Lake Worth, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dr. Alvarez
Phone: 615-875-3333
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Norfolk, Virginia 23507
Principal Investigator: Dr. Kimble
Phone: 757-446-7161
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Norfolk, VA
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Augusta, Georgia 30912
Principal Investigator: Dr. Ferris
Phone: 706-721-2535
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Chattanooga, Tennessee 37404
Principal Investigator: Dr. Brody
Phone: 423-648-7794
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Chattanooga, Tennessee 37403
Principal Investigator: Dr. DePasquale
Phone: 423-266-3636
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Clearwater, Florida 33759
Principal Investigator: Dr. Zbella
Phone: 727-724-9730
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Clearwater, FL
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Greenville, South Carolina 29615
Principal Investigator: Dr. Godwin
Phone: 864-770-0890
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Greenville, SC
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Houston, Texas 77074
Phone: 713-772-4876
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Hutchinson, Kansas 67502
Principal Investigator: Dr. Sanders
Phone: 620-694-4123
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Kissimmee, Florida 34741
Phone: 407-935-0093
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Marrero, Louisiana 70072
Principal Investigator: Dr. Nicholson-Uhl
Phone: 504-934-8093
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Memphis, Tennessee
Principal Investigator: Dr. Carter
Phone: 901-276-3222
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7233 East Baseline Road
Mesa, Arizona 85209
Principal Investigator: Dr. Gomez
Phone: 602-363-8105
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16319 Miramar Parkway
Miramar, Florida 33027
Principal Investigator: Dr. Tangir
Phone: 954-602-9723
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Myrtle Beach, South Carolina 29572
Principal Investigator: Dr. Kirkpatrick
Phone: 843-449-0803
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Dr. Tergas
Phone: 212-342-6895
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, New Jersey 07107
Principal Investigator: Dr. Einstein
Phone: 973-972-6262
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Newark, NJ
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1410 North 13th Street
Norfolk, Nebraska 68701
Principal Investigator: Dr. Vrbicky
Phone: 402-371-0797
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Norfolk, Virginia 23502
Principal Investigator: Dr. Parva
Phone: 757-471-3375
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Dr. Smith
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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118 North Country Road
Port Jefferson, New York 11777
Principal Investigator: Dr. Edwards
Phone: 631-656-4060
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Saginaw, Michigan 48604
Principal Investigator: Dr. Minnec
Phone: 989-497-5851
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7342 East Thomas Road
Scottsdale, Arizona 85251
Principal Investigator: Dr. Harris
Phone: 480-305-7423
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Towson, Maryland 21204
Principal Investigator: Dr. Daya
Phone: 410-616-9566
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Tucson, Arizona 85721
Principal Investigator: Dr. Goldberg
Phone: 520-546-4700
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West Palm Beach, Florida 33409
Principal Investigator: Dr. Ackerman
Phone: 561-478-3177
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Winston-Salem, North Carolina 27103
Principal Investigator: Dr. Parker
Phone: 336-397-3707
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