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NCT02345330 · ClinicalTrials.gov registry record · Phase 2
Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
A Phase 2 study, sponsored by OncoSec Medical Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02345330: Clinical Trial Phase 2 study, sponsored by OncoSec Medical Incorporated.
NCT02345330 is a Phase 2 study that was terminated before completion, run by OncoSec Medical Incorporated. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02345330, a Phase 2 study, was terminated before completion, sponsored by OncoSec Medical Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Interventions
- BIOLOGICAL Tavokinogene Telseplasmid (tavo)
- DEVICE OncoSec Medical System (OMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-05-21 |
| Est. Completion | 2016-11-14 |
| Phase | Phase 2 |
Why NCT02345330 stopped before completion
NCT02345330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Tavokinogene Telseplasmid (tavo) is the first listed.
NCT02345330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02345330 about?
NCT02345330 is a clinical study titled "Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)". 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 \[tavo\])...
What is the current status of trial NCT02345330?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2015-05-21. Estimated completion is 2016-11-14.
What interventions are being tested in trial NCT02345330?
The interventions under investigation include: Tavokinogene Telseplasmid (tavo) (BIOLOGICAL), OncoSec Medical System (OMS) (DEVICE).
Who is sponsoring clinical trial NCT02345330?
This trial is sponsored by OncoSec Medical Incorporated, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02345330's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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