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)
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | June 26, 2017 |
End Date: | September 2021 |
Contact: | Inovio Call Center |
Email: | clinical.trials@inovio.com |
Phone: | (267) 440-4237 |
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
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 HSIL
(VIN 2 or VIN 3) associated with 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
immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar HSIL
(VIN 2 or VIN 3) associated with 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
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.
We found this trial at
21
sites
1410 North 13th Street
Norfolk, Nebraska 68701
Norfolk, Nebraska 68701
Principal Investigator: Keith Vrbicky
Phone: 605-232-9000
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Anne Van Arsdale
Phone: 718-405-8214
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
Jupiter, Florida 33458
Principal Investigator: Donna Pinelli
Phone: 561-263-5791
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ronald Alvarez
Phone: 800-811-8480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Anthony Opipari
Phone: 734-763-5492
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
Principal Investigator: Stephen DePasquale
Phone: 423-266-3636
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Summer Dewdney
Phone: 312-942-7254
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
Columbus, Ohio 43231
Principal Investigator: Milroy Samuel
Phone: 614-682-5182
Click here to add this to my saved trials
969 Lakeland Drive
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Principal Investigator: D. Paul Seago
Phone: 601-200-4974
Click here to add this to my saved trials
Click here to add this to my saved trials
Kansas City, Kansas
Principal Investigator: Kevin Ault
Phone: 913-588-6287
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: William Bradley
Phone: 414-805-4763
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
Click here to add this to my saved trials
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Ana Tergas
Phone: 212-342-6895
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Newark, Delaware 19713
Principal Investigator: Mark Borowsky
Phone: 302-623-4450
Click here to add this to my saved trials
Newark, New Jersey 07103
Principal Investigator: Mark Einstein
Phone: 973-972-8367
Click here to add this to my saved trials
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Katherine Smith
Phone: 405-271-8001
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Robert Edwards
Phone: 412-641-3578
Click here to add this to my saved trials
Rio Piedras, 00935
Principal Investigator: Josefina Romaguera
Phone: 787-245-8082
Click here to add this to my saved trials
Scarborough, Maine 04074
Principal Investigator: Christopher Darus
Phone: 207-396-8670
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Robert Parker
Phone: 866-853-0220
Click here to add this to my saved trials