Cervical CancerPhase 1/2NCT02172911

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

A Phase 1/2 study testing INO-3112 and CELLECTRA™-5P in people with Cervical Cancer, run by Inovio Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccines delivered by electroporation (EP) to female participants with HPV-16 and/or 18-positive cervical carcinoma. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer
What is being tested?: INO-3112 and CELLECTRA™-5P
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesUnited States
Study dates: 6 Jun 2014to 7 Sep 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent.
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.
Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with HPV 16 and/or 18 and meet the following eligibility criteria for either Cohort 1 or Cohort 2.
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
No CNS/spinal metastases

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Able to initiate study treatment within 2 weeks of completion of last chemoradiation 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 weeks after 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 results must 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 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]).
Able and willing to comply with all study procedures.

Who cannot join

Pregnancy or breastfeeding.
History of previous therapeutic HPV vaccination.
Prior exposure to an investigational agent or device within 30 days of signing the ICF. 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 must have 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 active uncontrolled infection.

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Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
Congestive heart failure or prior history of New York Heart Association (NYHA) class III/ 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 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.
Active drug or alcohol use or dependence.
Imprisonment or compulsory detainment for treatment of either a psychiatric or physical (i.e. infectious disease) illness.
History of immunosuppressive or autoimmune disease.
Any other illnesses or conditions that in the opinion of the investigator may affect the safety of the participant or limit the evaluation of a participant or any study endpoint.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Chicago Medical Center
Chicago, Illinois, 60637
Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

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

Read the 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 participants 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 I) or in participants with persistent and/or recurrent cervical cancer associated with HPV 16 and/or 18 following salvage therapy (Cohort II).

Conditions: Cervical Cancer
Being tested: INO-3112, CELLECTRA™-5P
Keywords: Cervical cancer, Papillomavirus, Chemoradiation, Recurrent cervical cancer, Persistent cervical cancer
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INO-3112Biological
Also called VGX-3100, INO-9012
1.1 mL intramuscular (IM) injection of INO-3112 (VGX-3100 + INO-9012) was administered followed immediately by electroporation (EP) with CELLECTRA™-5P on Day 0, Week 4, Week 8, and Week 12.
CELLECTRA™-5PDevice
CELLECTRA™-5P was used for EP following IM delivery of INO-3112 on Day 0, Week 4, Week 8, and Week 12.

Study groups in NCT02172911
Study group	Role	What they receive
Cohort I: INO-3112: Curative Intent	Experimental	Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P. Receives: Biological: INO-3112; Device: CELLECTRA™-5P
Cohort II: INO-3112: Salvage Therapy	Experimental	Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P. Receives: Biological: INO-3112; Device: CELLECTRA™-5P

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Measured: Up to 36 weeks
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug. The severity of TEAEs was assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE,v 4.03). TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.
Measured: Up to 36 weeks
Percentage of Participants With Injection Site Reactions
Injection site reactions and administration site pain were evaluated starting 30 minutes following injection/EP. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Local reaction to the injectable product such as pain, tenderness, erythema/redness and induration/swelling were graded on a 4-point scale where: 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Potentially life-threatening.
Measured: Up to 36 weeks
Rates of Acute Gastrointestinal, Genitourinary, or Other Chemoradiation Side Effects Above the Expected, Graded Per Acute Radiation Morbidity Scoring Criteria
Measured: Up to 36 weeks
Change From Baseline in Hematocrit at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, and creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Week 4, 8,12,16,24, 32 and 48
Change From Baseline in Hemoglobin at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4, 8,12,16,24, 32 and 48
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Hematology parameters analyzed for this outcome measure included: white blood cell (WBC) count, count of lymphocytes (L), monocytes (M) and neutrophils (N).
Measured: Baseline and Weeks 4, 8,12,16,24, 32 and 48
Change From Baseline in Platelet Count at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4,8,12,16,24,32 and 48
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4 and 8
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Clinical chemistry parameter assessed in this outcome measure included alkaline phosphatase (ALP), alanine amino transferase (ALT) and aspartate amino transferase (AST).
Measured: Baseline and Weeks 4,8,12 and 16
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4,8,12 and 16
Change From Baseline in Albumin and Total Protein at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4,8,12 and 16
Change From Baseline in Creatine Phosphokinase (CPK) at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Week 16
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Measured: Baseline and Weeks 4, 8,12 and 16

Secondary outcomes (3)

Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC)
Whole blood and serum samples to be tested for antibodies to the human papillomavirus (HPV) E6 and E7 proteins and/or T-lymphocytes producing interferon-gamma (IFN-γ) elicited by INO-3112 were assessed by enzyme-linked immunosorbent spot-forming assay (ELISpot).
Measured: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Antigen-specific humoral responses against HPV E6 and E7 antigens induced by INO-3112 were measured using ELISA. Commercially available recombinant human HPV-16 and HPV-18 proteins were used to assess the induction of binding antibodies to each of the antigen components.
Measured: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
Antigen-specific humoral responses against HPV E6 and E7 antigens induced by INO-3112 were measured using ELISA. Commercially available recombinant human HPV-16 and HPV-18 proteins were used to assess the induction of binding antibodies to each of the antigen components.
Measured: Baseline and Weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 36, 40 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 20147 Sep 2017

First posted24 Jun 2014 (estimated)
Study start6 Jun 2014
Primary completion7 Sep 2017
Study completion7 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02172911
Sponsor's protocol ID: HPV-004
Status last verified: Feb 2021
First submitted: 18 May 2014
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

Publications

Bagarazzi ML, Yan J, Morrow MP, Shen X, Parker RL, Lee JC, Giffear M, Pankhong P, Khan AS, Broderick KE, Knott C, Lin F, Boyer JD, Draghia-Akli R, White CJ, Kim JJ, Weiner DB, Sardesai NY. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med. 2012 Oct 10;4(155):155ra138. doi: 10.1126/scitranslmed.3004414.
PubMed 23052295
Diehl MC, Lee JC, Daniels SE, Tebas P, Khan AS, Giffear M, Sardesai NY, Bagarazzi ML. Tolerability of intramuscular and intradermal delivery by CELLECTRA((R)) adaptive constant current electroporation device in healthy volunteers. Hum Vaccin Immunother. 2013 Oct;9(10):2246-52. doi: 10.4161/hv.24702. Epub 2013 Jun 4.
PubMed 24051434

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02172911
Acronym / sponsor ID: HPV-004
Conditions: Cervical Cancer
Keywords: Cervical cancer, Papillomavirus, Chemoradiation, Recurrent cervical cancer, Persistent cervical cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 6 Jun 2014 (actual)
Primary completion: 7 Sep 2017 (actual)
Study completion: 7 Sep 2017 (actual)
First posted: 24 Jun 2014 (estimated)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort I: INO-3112: Curative Intent	Experimental	Biological: INO-3112, Device: CELLECTRA™-5PCohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Cohort II: INO-3112: Salvage Therapy	Experimental	Biological: INO-3112, Device: CELLECTRA™-5PCohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Written informed consent.
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.
Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with HPV 16 and/or 18 and meet the following eligibility criteria for either Cohort 1 or Cohort 2.
Electrocardiogram (ECG) with no clinically significant findings.
Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ≤ Grade 1 at the time of screening.

Key exclusion criteria (16 listed)

Pregnancy or breastfeeding.
History of previous therapeutic HPV vaccination.
Prior exposure to an investigational agent or device within 30 days of signing the ICF. 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 must have had a serologic test performed within 12 months of informed consent).
Prior major surgery from which the participant has not yet recovered to baseline.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INO-3112Also: VGX-3100, INO-90121.1 mL intramuscular (IM) injection of INO-3112 (VGX-3100 + INO-9012) was administered followed immediately by electroporation (EP) with CELLECTRA™-5P on Day 0, Week 4, Week 8, and Week 12.	Biological	Cohort I: INO-3112: Curative Intent, Cohort II: INO-3112: Salvage Therapy
CELLECTRA™-5PCELLECTRA™-5P was used for EP following IM delivery of INO-3112 on Day 0, Week 4, Week 8, and Week 12.	Device	Cohort I: INO-3112: Curative Intent, Cohort II: INO-3112: Salvage Therapy

Primary outcome

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
Time frame: Up to 36 weeks
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03)
Time frame: Up to 36 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug. The severity of TEAEs was assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE,v 4.03). TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.
Percentage of Participants With Injection Site Reactions
Time frame: Up to 36 weeks
Injection site reactions and administration site pain were evaluated starting 30 minutes following injection/EP. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Local reaction to the injectable product such as pain, tenderness, erythema/redness and induration/swelling were graded on a 4-point scale where: 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Potentially life-threatening.
Rates of Acute Gastrointestinal, Genitourinary, or Other Chemoradiation Side Effects Above the Expected, Graded Per Acute Radiation Morbidity Scoring Criteria
Time frame: Up to 36 weeks
Change From Baseline in Hematocrit at the Indicated Time Points
Time frame: Baseline and Week 4, 8,12,16,24, 32 and 48
Clinical laboratory parameters (hematology, serum chemistry, and creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Hemoglobin at the Indicated Time Points
Time frame: Baseline and Weeks 4, 8,12,16,24, 32 and 48
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points
Time frame: Baseline and Weeks 4, 8,12,16,24, 32 and 48
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Hematology parameters analyzed for this outcome measure included: white blood cell (WBC) count, count of lymphocytes (L), monocytes (M) and neutrophils (N).
Change From Baseline in Platelet Count at the Indicated Time Points
Time frame: Baseline and Weeks 4,8,12,16,24,32 and 48
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
Time frame: Baseline and Weeks 4 and 8
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points
Time frame: Baseline and Weeks 4,8,12 and 16
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Clinical chemistry parameter assessed in this outcome measure included alkaline phosphatase (ALP), alanine amino transferase (ALT) and aspartate amino transferase (AST).
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points
Time frame: Baseline and Weeks 4,8,12 and 16
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Albumin and Total Protein at the Indicated Time Points
Time frame: Baseline and Weeks 4,8,12 and 16
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Creatine Phosphokinase (CPK) at the Indicated Time Points
Time frame: Baseline and Week 16
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points
Time frame: Baseline and Weeks 4, 8,12 and 16
Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase [CPK]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.

3 secondary outcomes

Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC)
Time frame: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
Time frame: Baseline and Weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 36, 40 and 48

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort I: INO-3112: Curative Intent	7	6
Cohort II: INO-3112: Salvage Therapy	3	1

Primary outcome: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)

Time frame: Up to 36 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort I: INO-3112: Curative Intent n = 7	Cohort II: INO-3112: Salvage Therapy n = 3
Value	100 (59.0 to 100.0)	100 (29.2 to 100.0)

Population analysed: Safety population included all participants who received at least one dose of study treatment plus EP.

Primary outcome: Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03)

Time frame: Up to 36 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort I: INO-3112: Curative Intent n = 7	Cohort II: INO-3112: Salvage Therapy n = 3
Anaemia	0 (0.0 to 41.0)	33.3 (0.8 to 90.6)
Disseminated Intravascular Coagulation	0 (0.0 to 41.0)	33.3 (0.8 to 90.6)
Abdominal Pain	14.3 (0.4 to 57.9)	0 (0.0 to 70.8)
Intestinal Perforation	0 (0.0 to 41.0)	33.3 (0.8 to 90.6)
Pneumonia	14.3 (0.4 to 57.9)	0 (0.0 to 70.8)
Pathological Fracture	0 (0.0 to 41.0)	33.3 (0.8 to 90.6)

Population analysed: Safety population included all participants who received at least one dose of study treatment plus EP.

Primary outcome: Percentage of Participants With Injection Site Reactions

Time frame: Up to 36 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort I: INO-3112: Curative Intent n = 7	Cohort II: INO-3112: Salvage Therapy n = 3
Injection Site Bruising	28.6 (3.7 to 71.0)	33.3 (0.8 to 90.6)
Injection Site Discolouration	0 (0.0 to 41.0)	33.3 (0.8 to 90.6)
Injection Site Erythema	14.3 (0.4 to 57.9)	0 (0.0 to 70.8)
Injection Site Haemorrhage	14.3 (0.4 to 57.9)	0 (0.0 to 70.8)
Injection Site Pain	14.3 (0.4 to 57.9)	66.7 (9.4 to 99.2)
Injection Site Swelling	14.3 (0.4 to 57.9)	33.3 (0.8 to 90.6)

Population analysed: Safety population included all participants who received at least one dose of study treatment plus EP.

Primary outcome: Rates of Acute Gastrointestinal, Genitourinary, or Other Chemoradiation Side Effects Above the Expected, Graded Per Acute Radiation Morbidity Scoring Criteria

Time frame: Up to 36 weeks

Population analysed: The above-mentioned outcome could not be assessed as no data were captured that reflect the expected rates of acute gastrointestinal, genitourinary or other chemoradiation side effects, in order to compare those collected on this study with those from prior studies. While adverse event data related to study therapy were captured, these were not graded per acute radiation morbidity score because of the above-noted limitation. No comparison was thus possible that would reflect rates expected.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort I: INO-3112: Curative Intent	3 of 7 (42.9%)	7 of 7 (100%)	0 of 7
Cohort II: INO-3112: Salvage Therapy	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23052295Bagarazzi ML, Yan J, Morrow MP, Shen X, Parker RL, Lee JC, Giffear M, Pankhong P, Khan AS, Broderick KE, Knott C, Lin F, Boyer JD, Draghia-Akli R, White CJ, Kim JJ, Weiner DB, Sardesai NY. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med. 2012 Oct 10;4(155):155ra138. doi: 10.1126/scitranslmed.3004414.
Background: PubMed 24051434Diehl MC, Lee JC, Daniels SE, Tebas P, Khan AS, Giffear M, Sardesai NY, Bagarazzi ML. Tolerability of intramuscular and intradermal delivery by CELLECTRA((R)) adaptive constant current electroporation device in healthy volunteers. Hum Vaccin Immunother. 2013 Oct;9(10):2246-52. doi: 10.4161/hv.24702. Epub 2013 Jun 4.
Sponsor's WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Skolnik, MD study director

Inovio Pharmaceuticals

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INO-3112 and CELLECTRA™-5P in people with Cervical Cancer, run by Inovio Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) (time frame: Up to 36 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172911, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.