Trials / Terminated
TerminatedNCT02345330
Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- OncoSec Medical Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the safety and effectiveness of ImmunoPulse IL-12® in treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC). ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid \[DNA\] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). Intratumoral tavo is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tavokinogene Telseplasmid (tavo) | Patients received intratumoral injection(s) of tavo. |
| DEVICE | OncoSec Medical System (OMS) | Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection. |
Timeline
- Start date
- 2015-05-21
- Primary completion
- 2016-11-14
- Completion
- 2016-11-14
- First posted
- 2015-01-26
- Last updated
- 2023-05-15
- Results posted
- 2018-01-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02345330. Inclusion in this directory is not an endorsement.