Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02172911
First received: May 18, 2014
Last updated: February 6, 2017
Last verified: February 2017
  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.

Condition Intervention Phase
Cervical Cancer
Biological: 1.1 mL of INO-3112 delivered via IM EP
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Evaluate safety and tolerability of INO-3112 delivered IM EP [ Time Frame: 3 years and 4 months from screening ]

    Evaluate safety and tolerability of INO-3112 delivered IM EP in women with newly diagnosed, inoperable cervical cancer associated with HPV 16 and/or 18 after completion of standard chemoradiation therapy with curative intent or in women with persistent and/or recurrent cervical cancer associated with HPV 16 and/or 18 following salvage therapy compared to that expected/reported with "standard" therapy alone"

    1. Incidence of adverse events
    2. Injection site reactions including pain, tenderness, erythema and induration at the administration site
    3. Rates of acute gastrointestinal, genitourinary, or other chemoradiation side effects above the expected, graded per Acute Radiation Morbidity Scoring Criteria (RTOG)
    4. Changes in laboratory parameters from baseline


Secondary Outcome Measures:
  • Evaluate immunogenicity of INO-3112 delivered IM EP [ Time Frame: 3 years and 4 months from screening ]

    Evaluate the cellular and humoral immune responses to immunotherapy with INO-3112 delivered IM EP in women with newly diagnosed, inoperable cervical cancer associated with HPV 16 and/or 18 after completion of standard chemoradiation therapy with curative intent or in women with persistent and/or recurrent cervical cancer associated with HPV 16 and/or 18 following salvage therapy

    1. Antigen-specific cellular immune responses to INO-3112
    2. Antigen-specific humoral responses to HPV-E6 and -E7 by ELISA


Other Outcome Measures:
  • Evaluate clinical responses following treatment with INO-3112 [ Time Frame: 3 years and 4 months from screening ]

    Evaluate clinical responses following treatment with INO-3112 delivered IM EP in women with newly diagnosed, inoperable cervical cancer associated with HPV 16 and/or 18 after completion of standard chemoradiation therapy with curative intent or in women with persistent and/or recurrent cervical cancer associated with HPV 16 and/or 18 following salvage therapy

    1. Changes in standard uptake volume on PET/CT scans
    2. Evaluation of subject's relative immune competence longitudinally throughout the study starting at the screening visit
    3. Changes in cervical histology
    4. Local immune responses to INO-3112 in cervical tissue samples
    5. Progression free survival at 18 months
    6. Disease-free survival assessed in accordance with RECIST v1.1


Estimated Enrollment: 10
Study Start Date: May 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INO-3112
1.1 ml of INO-3112 (6 mg of VGX-3100 and 1 mg of INO-9012)
Biological: 1.1 mL of INO-3112 delivered via IM EP
Eligible subjects who consent to participate in the study will receive a 1.1 mL IM injection of INO-3112 in the deltoid followed immediately by EP with CELLECTRA®-5P.
Other Names:
  • VGX-3100
  • INO-9012

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172911

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Study Director: Jeffrey Skolnik, MD Inovio Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02172911     History of Changes
Other Study ID Numbers: HPV-004
Study First Received: May 18, 2014
Last Updated: February 6, 2017

Keywords provided by Inovio Pharmaceuticals:
Cervical cancer
Papillomavirus
Chemoradiation
Recurrent cervical cancer
Persistent cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 25, 2017