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New treatment option for Cervical Intraepithelial Neoplasia Grade 2/3
Official title PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
ClinicalTrials.gov ID: NCT07454915
What this study is testing
What is PVX4 Combination Product?
PVX4 Combination Product is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for cervical intraepithelial neoplasia grade 2/3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2/3) as compared to the administration of placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Female people 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review.
- Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study...
- HIV negative
- Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year
- Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier...
You likely can't join if
- Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
- Patients with immunodeficiency, or treatment with immunosuppressive medications
- Administration of any blood product within 3 months of enrollment.
- Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)
- Participation in a study with an investigational compound or device within 30 days of signing informed consent.
- History of seizures (unless seizure free for 5 years)
See the full eligibility criteria
- Female people 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review.
- Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry
- HIV negative
- Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year
- Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is...
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count \>3,000/mcL; lymphocyte number \>500/mcL; absolute neutrophil count \>1,000/mcL...
- Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
- Patients with immunodeficiency, or treatment with immunosuppressive medications
- Administration of any blood product within 3 months of enrollment.
- Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)
- Participation in a study with an investigational compound or device within 30 days of signing informed consent.
- History of seizures (unless seizure free for 5 years)
- Previous cancer history within the past 5 years, except localized skin cancer.
- Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.
- Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).
- Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment
- High-grade intraepithelial lesions (CIN2/3) encompassing more than 180-degree (more than 2 quarters) of cervix
- Positive HBV PCR if Hepatitis B surface antigen positive
- Positive HCV PCR if anti-HCV positive
- Border of high-grade intraepithelial lesions (CIN2/3) could not be completely observed by colposcope and positive for high grade disease by endocervical curettage.
- Cervical biopsy and/or ECC of adenocarcinoma in situ (AIS)
- Pre-biopsy Pap of Atypical Glandular Cells (AGC)/AGC favor neoplasm, squamous cell carcinoma (SCC), or cervical biopsy of CIN2/3 with postmenopausal bleeding
- Participant has:
- Less than 2 acceptable potential injection sites for IM injection and electroporation considering the left and right medial deltoid, and anterolateral quadriceps muscles. A site for injection and electroporation is not...
- Note: To ensure adequate muscle mass for administrations, for participants with a weight ≤65 kg, potentially eligible administration sites are confined to the outer aspect of the upper thigh (left or right vastus...
- Contraindication to intramsucular injections and blood draws.
- A metal implant or implantable device within the area of the electroporation injection site at \> 2 of the eligible injection sites.
- A nonremovable electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
- Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the...
- Vulnerable participants (e.g., incarcerated individuals, individuals under a legal protection measure).
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
- Kaohsiung, Taiwan, Taiwan
- Taichung, Taiwan, Taiwan
- Tainan, Taiwan, Taiwan
- Taipei, Taiwan, Taiwan
- Taoyuan, Taiwan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States; Kaohsiung, Taiwan, Taiwan; Taichung, Taiwan, Taiwan; Tainan, Taiwan, Taiwan; Taipei, Taiwan, Taiwan; Taoyuan, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.