REVEAL 2: 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 - REVEAL 2 (Randomized Evaluation of VGX-3100 and Electroporation for Treatment of Cervical HSIL)

Inovio Pharmaceuticals, Inc.0 个研究点目标入组 198 人开始时间: 2019年1月24日最近更新: 2020年9月15日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Inovio Pharmaceuticals, Inc.
入组人数: 198

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•1. Women aged 18 years and above that meet the minimum age of consent per local regulations;
•2. Confirmed cervical infection with HPV types 16 and/or 18 at screening by cobas™ HPV test;
•3. Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis must be collected within 10 weeks prior to anticipated date of first dose of study drug;
•4. Histologic evidence of cervical HSIL as confirmed by PAC at screening;
•5. Must understand, agree and be able to comply with the requirements of the protocol. Subjects must be willing and able to provide voluntary consent to participate and sign a Consent Form prior to study-related activities;
•6. Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure (i.e. excision, 4 quadrant biopsy with ECC, or 4-quadrant biopsy) required at Week 36;
•7. Satisfactory colposcopy at screening, defined as full visualization of the squamo-columnar junction (Type I or II transformation zone) and complete visualization of the upper limit of aceto-white epithelium or suspected CIN disease;
•8. Cervical lesion that is accessible for sampling by biopsy instrument (e.g. Mini-Tischler device);
•9. Cervical lesion of adequate size to ensure that a visible lesion remains after screening biopsy;
•10. Must meet one of the following criteria with respect to their reproductive capacity:
•a) Post-menopausal as defined by spontaneous amenorrhea for more than 12 months;
•b) Surgically sterile due to absence of ovaries or due to a bilateral tubal ligation/occlusion performed more than 12 months prior to screening;
•c) Women of Child Bearing Potential (WOCBP) is 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. The following methods are acceptable :
•- Hormonal contraception: either combined or progestin-alone including oral contraceptives, injectable, implants, vaginal ring, or percutaneous patches. Hormonal contraceptives must not be used in subjects with a history of hypercoagulability (e.g., deep vein thrombosis, pulmonary embolism);
•- Abstinence from penile-vaginal intercourse when this is the subject’s preferred mode of sexual activity;
•- Intrauterine device or intrauterine system;
•- Male partner sterilization at least 6 months prior to the female subject’s entry into the study, and this male is the sole partner for that subject
•11. Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 188
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1. Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal (inclusive of cervical HPV-related lesions that extend into the vaginal vault), or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening;
•2. Cervical lesion(s) that cannot be fully visualized on colposcopy due to extension high into cervical canal at screening;
•3. History of ECC which showed cervical HSIL indeterminate, or insufficient for diagnosis (ECC is not performed as part of study screening);
•4. Treatment for cervical HSIL within 4 weeks prior to screening;
•5. Pregnant, breastfeeding or considering becoming pregnant through week 36;
•6. History of previous therapeutic HPV vaccination (licensed prophylactic HPV vaccines are allowed, e.g. Gardasil™, Cervarix™);
•7. Presence of any abnormal clinical screening laboratory values greater than Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 or less than Grade 1 but deemed clinically significant by the investigator within 30 days prior to Day 0;
•8. Immunosuppression as a result of underlying illness or treatment including:
•a) History of or positive serologic test for HIV at screening (performed within 30 days prior to Day 0)
•b) Primary immunodeficiencies
•c) Long term use (= 7 days) of oral or parenteral glucocorticoids at a dose of =20 mg/day of prednisone equivalent; (use of inhaled, otic, and ophthalmic corticosteroids are allowed)
•d) Current or anticipated use of disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-a inhibitors (e.g. infliximab, adalimumab or etanercept)
•e) History of solid organ or bone marrow transplantation
•f) Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results.
•g) Subjects who are malnourished based on screening labs, medical history (e.g. clinically significant unintentional weight loss) and physical exam, as determined by investigator clinical judgement
•9. Receipt of any non-study, non-live vaccine within 2 weeks of Day 0;
•10. Receipt of any non-study, live vaccine (e.g. measles vaccine) within 4 weeks of Day 0;
•11. Current or history of clinically significant, medically unstable disease which, in the judgment of the investigator, would jeopardize the safety of the subject, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results (e.g. chronic renal failure; angina, myocardial ischemia or infarction, class 3 or higher congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)
•12. Malignancy or treatment for malignancy within 2 years of screening, with the exception of superficial skin cancers that only require local excision;
•13. Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners (e.g. anticoagulants or antiplatelet drugs) within 2 weeks of Day 0;
•14. History of seizures unless seizure free for 5 years with the use of one or fewer antiepileptic agents;
•15. Sustained, manually confirmed, sitting systolic blood pressure >150 mm Hg or <90 mm Hg or a diastolic blood pressure >95 mm Hg at Scr

研究者

发起方

Inovio Pharmaceuticals, Inc.

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