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NCT01502293 · ClinicalTrials.gov registry record · Phase 2
Trial of pIL-12 Electroporation Malignant Melanoma
A Phase 2 study of Melanoma, sponsored by OncoSec Medical Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 6
- Study locations
NCT01502293: Completed Phase 2 study of Melanoma, sponsored by OncoSec Medical Incorporated.
NCT01502293 is a Phase 2 study of Melanoma that has completed, run by OncoSec Medical Incorporated. The registered enrollment target is 51 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502293, a Phase 2 study of Melanoma, has completed, sponsored by OncoSec Medical Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will assess the safety and effectiveness of different dosing regimens of ImmunoPulse IL-12® in malignant melanoma. ImmunoPulse IL-12® is the combination of intratumoral 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). ImmunoPulse IL-12® 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
ORR 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 Modified "Skin" Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension
Conditions Studied
Interventions
- BIOLOGICAL Tavokinogene Telseplasmid (tavo)
- DEVICE OncoSec Medical System (OMS)
Study Locations (6)
California
- UCSF Helen Diller Comprehensive Cancer Center - San Francisco
- John Wayne Cancer Institute - Santa Monica
Colorado
- University of Colorado Denver - Denver
Florida
- Lakeland Regional Cancer Center - Lakeland
Pennsylvania
- St. Luke's University Health Network - Bethlehem
Washington
- Seattle Cancer Care Alliance /University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-02-14 |
| Est. Completion | 2016-03-21 |
| Phase | Phase 2 |
What the finished NCT01502293 record still lists
NCT01502293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Tavokinogene Telseplasmid (tavo) is the first listed.
NCT01502293 lists 6 locations in 5 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT01502293 about?
NCT01502293 is a clinical study titled "Trial of pIL-12 Electroporation Malignant Melanoma". This study will assess the safety and effectiveness of different dosing regimens of ImmunoPulse IL-12® in malignant melanoma. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) and in vivo electroporation-mediated plasmid deox...
What is the current status of trial NCT01502293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2012-02-14. Estimated completion is 2016-03-21.
What conditions does trial NCT01502293 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01502293?
The interventions under investigation include: Tavokinogene Telseplasmid (tavo) (BIOLOGICAL), OncoSec Medical System (OMS) (DEVICE).
Who is sponsoring clinical trial NCT01502293?
This trial is sponsored by OncoSec Medical Incorporated, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01502293 being conducted?
This trial has 6 study locations across California, Colorado, Florida, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01502293's enrollment target sits among peer trials
51 161st of 266 higher than 105 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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