Clinical Trials /

A Study of INO-3112 DNA Vaccine With Electroporation in Patients With Cervical Cancer

NCT02172911

Description:

This is an open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccines delivered by Electroporation to female subjects with HPV-16 and/or 18-positive cervical carcinoma.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

A Study of INO-3112 DNA Vaccine With Electroporation in Patients With <span class="go-doc-concept go-doc-disease">Cervical Cancer</span>

Title

  • Brief Title: A Study of INO-3112 DNA Vaccine With Electroporation in Patients With Cervical Cancer
  • Official Title: Phase I/IIA, Open-Label, Safety, Tolerability, and Immunogenicity Study of INO-3112 Delivered by Electroporation (EP) in Women With Cervical Cancer After Chemoradiation for Newly Diagnosed Disease or Therapy for Recurrent and/or Persistent Disease
  • Clinical Trial IDs

    NCT ID: NCT02172911

    ORG ID: HPV-004

    Trial Conditions

    Cervical Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is an open-label study to evaluate the safety, tolerability, and immunogenicity of
    INO-3112 DNA vaccines delivered by Electroporation to female subjects with HPV-16 and/or
    18-positive cervical carcinoma.

    Detailed Description

    This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and
    immunogenicity of INO-3112 [VGX-3100 and INO-9012] delivered intramuscularly by
    electroporation in approximately 30 female subjects with biopsy-proven, Stage IB-IVB
    inoperable invasive cervical carcinoma associated with HPV 16 and/or 18 who have completed
    treatment with standard chemoradiation therapy with curative intent (Cohort 1) or in
    subjects with persistent and/or recurrent cervical cancer associated with HPV 16 and/or 18
    following salvage therapy (Cohort 2).

    Trial Arms

    Name Type Description Interventions
    INO-3112 Experimental 1.1 ml of INO-3112 (6 mg of VGX-3100 and 1 mg of INO-9012)

    Eligibility Criteria

    Inclusion Criteria:

    1. Written informed consent;

    2. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous
    cell carcinoma of the cervix. Not accepted are small cell, clear cell and other rare
    variants of the classical adenocarcinoma;

    3. Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with
    HPV 16 and/or 18 and meeting the following eligibility criteria for either Cohort 1
    or Cohort 2;

    1. Cohort 1

    - Newly diagnosed inoperable cervical cancer treated with chemoradiation
    therapy with curative intent and life expectancy of at least 12 months as
    assessed by the investigator

    o No CNS/spinal metastases

    - Able to initiate study treatment within 2 weeks of completion of last
    chemoradiation treatment;

    2. Cohort 2

    - Persistent and/or recurrent cervical cancer

    o No CNS/spinal metastases

    - Able to initiate study treatment at least 2 weeks but no more than 4 weeks
    after completion of salvage therapy

    - Subject has a life expectancy of at least 12 months as assessed by the
    investigator

    4. ECG with no clinically significant findings;

    5. Chemistry, liver function tests, renal function, total CPK and hematology lab results
    must be Grade 1 at the time of screening;

    6. Eastern Cooperative Oncology Group (ECOG) Performance status of 1; ;

    7. Adequate venous access for repeated blood sampling according to study schedule;

    8. Women of child-bearing potential must have a negative serum pregnancy test and agree
    to remain sexually abstinent, have a partner who is sterile (i.e., vasectomy), or use
    two medically effective methods of contraception (e.g., oral contraception, barrier
    methods, spermicide, intrauterine device (IUD));

    9. Able and willing to comply with all study procedures.

    Exclusion Criteria:

    1. Pregnancy or breastfeeding;

    2. History of previous therapeutic HPV vaccination;

    3. Prior exposure to an investigational agent or device within 30 days of signing the
    ICF. Of note, the subject may participate in observational studies;

    4. Positive serological test for HIV, Hep B or Hep C or history of HIV infection,
    Hepatitis B or Hepatitis C (women with cured HCV will be allowed; subject must have
    had an serologic test performed within 12 months of informed consent);

    5. Prior major surgery from which the subject has not yet recovered to baseline;

    6. High medical risks because of non-malignant systemic disease or with active
    uncontrolled infection;

    7. Current malignancies at other sites, with the exception of adequately treated basal
    or squamous cell carcinoma of the skin;

    8. Congestive heart failure or prior history of New York Heart Association (NYHA) class
    III/ IV cardiac disease;

    9. Use of topical corticosteroids at or near the intended administration site;

    10. Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);

    11. History of seizures (unless seizure free for 5 years);

    12. Tattoos or scars within 2 cm of the intended site of injection or if there is
    implanted metal within the same limb. Any device implanted in the chest (e.g.,
    cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the
    same side of the body;

    n) Active drug or alcohol use or dependence; o) Imprisonment or compulsory detainment for
    treatment of either a psychiatric or physical (i.e. infectious disease) illness; p)
    History of immunosuppressive or autoimmune disease; q) Any other illnesses or conditions
    that in the opinion of the investigator may affect the safety of the subject or limit the
    evaluation of a subject or any study endpoint.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Evaluate safety and tolerability of INO-3112 delivered IM EP

    Secondary Outcome Measures

    Evaluate immunogenicity of INO-3112 delivered IM EP

    Trial Keywords

    Cervical cancer

    Papillomavirus

    Chemoradiation

    Recurrent cervical cancer

    Persistent cervical cancer