Cervical Intraepithelial Neoplasia 3NCT03206138
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.
A study testing GX-188E, GX-I7 and GX-188E, Imiquimod in people with Cervical Intraepithelial Neoplasia 3, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia 3
- What is being tested?
- GX-188E, GX-I7 and GX-188E, Imiquimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2017to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- Female subjects age 19-50 years.
- HPV 16 and/or 18 positive.
- Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
- Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.
Who cannot join
- Pregnancy or breastfeeding
- History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
- Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Genexine, 031-628-3271 ext. 82, yyhwang@genexine.com
Jong-Sup Park, M.D
About this study
Official title: A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Being tested
- GX-188E, GX-I7, GX-188E, Imiquimod
- Keywords
- Investigator trial, Cervical Intraepithelial Neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-188E, GX-I7Biological
Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.
GX-188E, ImiquimodBiological
1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.
| Study group | Role | What they receive |
|---|---|---|
| GX-188E, GX-I7 | Experimental | GX-188E + GX-I7 Receives: Biological: GX-188E, GX-I7 |
| GX-188E, Imiquimod | Experimental | GX-188E + Imiquimod Receives: Biological: GX-188E, Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
Measured: at week 20
Secondary outcomes (3)
Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.
Measured: at week 20, and week 36
The change of cytology of uterine cervix compared to baseline.
Measured: at screening, week 12, week 20, and week 36
Flt-3L concentrations in blood samples.
Measured: at week 14, week 20, and week 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start30 May 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genexine, Inc.
- Responsible party
- Principal investigator, Jongsup Park, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206138
- Sponsor's protocol ID
- GX-188E_GX-I7_IMQ_CIN3
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
- ClinicalTrials.gov ID
- NCT03206138
- Acronym / sponsor ID
- GX-188E_GX-I7_IMQ_CIN3
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Keywords
- Investigator trial, Cervical Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Genexine, Inc.
- Study start
- 30 May 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GX-188E, GX-I7 | Experimental | Biological: GX-188E, GX-I7GX-188E + GX-I7 |
| GX-188E, Imiquimod | Experimental | Biological: GX-188E, ImiquimodGX-188E + Imiquimod |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- Female subjects age 19-50 years.
- HPV 16 and/or 18 positive.
- Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
- Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
- Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-188E, GX-I7Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times. | Biological | GX-188E, GX-I7 |
| GX-188E, Imiquimod1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times. | Biological | GX-188E, Imiquimod |
Primary outcome
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
Time frame: at week 20
3 secondary outcomes
Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.
Time frame: at week 20, and week 36
The change of cytology of uterine cervix compared to baseline.
Time frame: at screening, week 12, week 20, and week 36
Flt-3L concentrations in blood samples.
Time frame: at week 14, week 20, and week 36.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Related trials for Cervical Intraepithelial Neoplasia 3
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Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
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Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
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PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Cervical Intraepithelial Neoplasia Grade 2/3, Human Papilloma Virus Infection Type 16
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GX-188E, GX-I7 and GX-188E, Imiquimod in people with Cervical Intraepithelial Neoplasia 3, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong-Sup Park (+82-2-2258-2724, jspark@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects. (time frame: at week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.