CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Tavokinogene Telseplasmid (tavo) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01440816
NCT01440816Phase 2Completed

A Phase II Study of Intratumoral Injection of Interleukin-12 Plasmid and in Vivo Electroporation in Patients With Merkel Cell Carcinoma

OncoSec Medical Incorporated·interventional·Posted Sep 27, 2011·Updated May 15, 2023

In Brief

A Phase 2 clinical trial evaluating Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS) for Merkel Cell Carcinoma. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This phase II trial studies the effectiveness of ImmunoPulse IL-12® in treating patients with Merkel cell cancer. 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). Placing the gene for interleukin-12 into Merkel cells may help the mount an effective anti-tumor immune response to kill tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartJan 3, 2012
Primary CompletionApr 10, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.8 years ago

Interventions

Tavokinogene Telseplasmid (tavo)biological

Patients received intratumoral injection(s) of tavo.

OncoSec Medical System (OMS)device

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.