Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL (NCT03911076) | Clinical Trial Compass
TerminatedPhase 2
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL
Stopped: Slow recruitment/funding
United States16 participantsStarted 2019-05-22
Plain-language summary
* To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
* To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6
Who can participate
Age range
25 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female subjects age 25-70 years with confirmation of ASC-US, ASC-H, or LSIL by liquid-based cytology
. HIV uninfected
. Patients whose cytologic specimen is HPV16+ by Aptima HPV 16 18/45 Genotype Assay
. Body Mass Index ≤ 32 kg/m2
. Hepatitis B surface antigen negative
. Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV positive
. Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form, and with anticipated availability for the planned follow-up period of one year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Timeframe: 12 months
2
Percent of patients that have cleared HPV16 at Month 6
. 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 sterile (i.e., vasectomy) through 6 months.
Exclusion criteria
. 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 (4weeks for measles 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)
. Patients with positive serological test for human immunodeficiency virus (HIV).
. Previous cancer history within the past 5 years.