Clinical trial · Interventional
A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer
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
NCT02172911CI-TRIAL-00050209completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CELLECTRA™-5P | Device | — | UNRESOLVED |
| INO-3112 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I: INO-3112: Curative Intent
- description
- 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.
- interventionNames
- Biological: INO-3112
- Device: CELLECTRA™-5P
- type
- EXPERIMENTAL
- label
- Cohort II: INO-3112: Salvage Therapy
- description
- 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.
- interventionNames
- Biological: INO-3112
- Device: CELLECTRA™-5P
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 meet 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
* 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
* 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
4. Electrocardiogram (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 the 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 participant 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; participant must have had a serologic test performed within 12 months of informed consent).
5. Prior major surgery from which the participant 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.
13. Active drug or alcohol use or dependence.
14. Imprisonment or compulsory detainment for treatment of either a psychiatric or physical (i.e. infectious disease) illness.
15. History of immunosuppressive or autoimmune disease.
16. 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.References
Publications (2)
- BACKGROUNDBagarazzi 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. PMID 23052295
- BACKGROUNDDiehl 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. PMID 24051434