Last updated: February 1, 2021
Sponsor: Inovio Pharmaceuticals
Overall Status: Completed
Phase
1/2
Condition
Vaginal Cancer
Cervical Cancer
Pelvic Cancer
Treatment
N/AClinical Study ID
NCT02172911
HPV-004
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent.
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamouscell carcinoma of the cervix. Not accepted are small cell, clear cell and other rarevariants of the classical adenocarcinoma.
- Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated withHPV 16 and/or 18 and meet the following eligibility criteria for either Cohort 1 orCohort 2.
- Cohort 1
- Newly diagnosed inoperable cervical cancer treated with chemoradiationtherapy with curative intent and life expectancy of at least 12 months asassessed by the investigator
- No CNS/spinal metastases
- Able to initiate study treatment within 2 weeks of completion of lastchemoradiation treatment
- Cohort 2
- Persistent and/or recurrent cervical cancer
- No CNS/spinal metastases
- Able to initiate study treatment at least 2 weeks but no more than 4 weeksafter completion of salvage therapy
- Life expectancy of at least 12 months as assessed by the investigator
- Electrocardiogram (ECG) with no clinically significant findings.
- Chemistry, liver function tests, renal function, total CPK and hematology lab resultsmust be ≤ Grade 1 at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1.
- Adequate venous access for repeated blood sampling according to the study schedule.
- Women of child-bearing potential must have a negative serum pregnancy test and agreeto remain sexually abstinent, have a partner who is sterile (i.e., vasectomy), or usetwo medically effective methods of contraception (e.g., oral contraception, barriermethods, spermicide, intrauterine device [IUD]).
- Able and willing to comply with all study procedures.
Exclusion
Exclusion Criteria:
- Pregnancy or breastfeeding.
- History of previous therapeutic HPV vaccination.
- Prior exposure to an investigational agent or device within 30 days of signing theICF. Of note, the participant may participate in observational studies.
- 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; participant musthave had a serologic test performed within 12 months of informed consent).
- Prior major surgery from which the participant has not yet recovered to baseline.
- High medical risks because of non-malignant systemic disease or with activeuncontrolled infection.
- Current malignancies at other sites, with the exception of adequately treated basal orsquamous cell carcinoma of the skin.
- Congestive heart failure or prior history of New York Heart Association (NYHA) classIII/ IV cardiac disease.
- Use of topical corticosteroids at or near the intended administration site.
- Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White).
- History of seizures (unless seizure free for 5 years).
- Tattoos or scars within 2 cm of the intended site of injection or if there isimplanted metal within the same limb. Any device implanted in the chest (e.g., cardiacpacemaker or defibrillator) excludes the use of the deltoid muscle on the same side ofthe body.
- Active drug or alcohol use or dependence.
- Imprisonment or compulsory detainment for treatment of either a psychiatric orphysical (i.e. infectious disease) illness.
- History of immunosuppressive or autoimmune disease.
- Any other illnesses or conditions that in the opinion of the investigator may affectthe safety of the participant or limit the evaluation of a participant or any studyendpoint.
Study Design
Total Participants: 10
Study Start date:
June 06, 2014
Estimated Completion Date:
September 07, 2017
Study Description
Connect with a study center
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago Medical Center Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available

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