EUCTR2016-002761-63-CZ进行中（未招募）1 期
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 - Randomized Evaluation of VGX-3100 and Electroporation for the treatment of Cervical dysplasia REVEA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 198
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
- •Each subject must meet all of the following criteria to be enrolled in the study:
- •1. Women aged 18 years and above and meets the minimum age of
- •consent per local regulations;
- •2. Confirmed cervical infection with HPV types 16 and/or 18 at screening by cobasTM 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) Is post-menopausal as defined by spontaneous amenorrhea for more
- •than 12 months
- •b) Is surgically sterile due to absence of ovaries or due to a bilateral tubal ligation/occlusion performed more than 12 months prior to screening
- •c) 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 and usual lifestyle
- •- 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) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects meeting any of the following criteria will be excluded from
- •enrollment in the study:
- •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. ECC that shows a potentially untreated carcinoma, untreated HSIL,
- •indeterminate, or insufficient for diagnosis (ECC is not required to be 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 visit;
- •6. History of previous therapeutic HPV vaccination (licensed prophylactic
- •HPV vaccines are allowed, e.g. Gardasil™, Silgard ™, Cervarix™);
- •7. Presence of any unresolved abnormal clinical screening laboratory
- •values of Grade 1 or greater per Common Toxicity Criteria for Adverse
- •Events (CTCAE) v 4.03 and deemed clinically significant by the
- •investigator within 45 days prior to Day 0;
- •8. Immunosuppression as a result of underlying illness or treatment
- •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 antirheumatic
- •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 (i.e. medically significant
- •unintentional weight loss, kwashiorkor, or marasmus) based on
- •screening labs, medical history and physical exam per the investigator's
- •clinical judgment.
- •9. Receipt of any non-study, non-live vaccine within 2 weeks of dosing;
- •10. Receipt of any non-study, live vaccine (e.g. measles vaccine) within
- •4 weeks of dosing;
- •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);
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