Trials / Completed
CompletedNCT02172911
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | INO-3112 | 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. |
| DEVICE | CELLECTRA™-5P | CELLECTRA™-5P was used for EP following IM delivery of INO-3112 on Day 0, Week 4, Week 8, and Week 12. |
Timeline
- Start date
- 2014-06-06
- Primary completion
- 2017-09-07
- Completion
- 2017-09-07
- First posted
- 2014-06-24
- Last updated
- 2021-02-21
- Results posted
- 2021-02-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02172911. Inclusion in this directory is not an endorsement.