REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (REVEAL 1)
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| ClinicalTrials.gov Identifier: NCT03185013 |
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Recruitment Status :
Completed
First Posted : June 14, 2017
Last Update Posted : December 8, 2021
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Sponsor:
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Inovio Pharmaceuticals
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Dysplasia Cervical High Grade Squamous Intraepithelial Lesion HSIL | Biological: VGX-3100 Biological: Placebo Device: Electroporation (EP) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 28, 2017 |
| Actual Primary Completion Date : | July 8, 2020 |
| Actual Study Completion Date : | April 7, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: VGX-3100 + EP
IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
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Biological: VGX-3100
1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. Device: Electroporation (EP) Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device. |
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Placebo Comparator: Placebo + EP
IM injections with matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
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Biological: Placebo
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. Device: Electroporation (EP) Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device. |
Primary Outcome Measures :
- Percentage of Participants with No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for evidence of cervical HSIL on histology as well as evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.
Secondary Outcome Measures :
- Safety: Number of Participants with Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment and for the Duration of the Study [ Time Frame: From baseline to Week 88 ]An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
- Percentage of Participants with No Evidence of Cervical HSIL at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for evidence of cervical HSIL on histology at the Week 36 visit.
- Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing.
- Percentage of Participants with No Evidence of Low Grade Squamous Intraepithelial Lesion (LSIL) or HSIL at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for evidence of LSIL (i.e. slightly abnormal cells on the surface of the cervix) or HSIL (i.e. evidence of cervical intraepithelial neoplasia grade 1 [CIN1], CIN2 or CIN3 on biopsies or excisional treatment) on histology at the Week 36 visit.
- Percentage of Participants with No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18 at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for evidence of LSIL (i.e. slightly abnormal cells on the surface of the cervix) or HSIL (i.e. evidence of CIN1, CIN2 or CIN3 on biopsies or excisional treatment) on histology and no evidence of HPV-16 and/or HPV-18 by type-specific HPV testing at the Week 36 visit.
- Percentage of Participants with No Progression of Cervical HSIL to Cervical Carcinoma from Baseline to Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for progression of cervical HSIL to cervical carcinoma from baseline on histology at the Week 36 visit.
- Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations at Week 36 [ Time Frame: At Week 36 ]Participants will be evaluated for HPV-16 and/or HPV-18 status in specimens from non-cervical anatomic locations at the Week 36 Visit.
- Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations [ Time Frame: At baseline, Week 15 and Week 36 ]Levels of anti-HPV-16 and anti-HPV-18 antibody concentrations will be measured in serum samples of participants using a standardized assay at baseline, Week 15 and Week 36.
- Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: At baseline, Week 15 and Week 36. ]Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at baseline, Week 15 and Week 36. Assessment of cellular immune activity will be performed.
- Change from Baseline in Flow Cytometry Response Magnitude [ Time Frame: At baseline, Week 15 ]Assessment of cellular immune activity will be performed using flow cytometry.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185013
Locations
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Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
| Study Director: | Jeffrey Skolnik, MD | Inovio Pharmaceuticals |
| Responsible Party: | Inovio Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03185013 |
| Other Study ID Numbers: |
HPV-301 2016-002761-63 ( EudraCT Number ) |
| First Posted: | June 14, 2017 Key Record Dates |
| Last Update Posted: | December 8, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by Inovio Pharmaceuticals:
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Cervical intraepithelial neoplasia (CIN) Human papillomavirus (HPV) High grade squamous intraepithelial lesion (HSIL) |
CIN 2 CIN 3 papillomavirus |
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia Squamous Intraepithelial Lesions of the Cervix Carcinoma, Squamous Cell Carcinoma in Situ Precancerous Conditions Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell |