Trial intelligence / Profile preview

Intratumoral pIL-12 Electroporation in Advanced Melanoma

NCT01502293Phase 2

Key facts

Status: Completed
Start: Feb 2012
Primary completion: Mar 2016
Countries: 1
Sponsor: OncoSec Medical
Modality: Gene Editing, Gene Silencing, Gene Addition/Replacement

Drugs: tavokinogene telseplasmid
Conditions: melanoma

Overview

Phase 2, open-label trial of tavokinogene telseplasmid in melanoma (3 arms), sponsored by OncoSec Medical. Primary endpoint: Best Overall Objective Response Rate by Modified 'Skin' RECIST at Week 48. Started Feb 2012; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

Main Study: tavo-EP
tavo-EP on Days 1, 5, 8 every 3 months.
Addendum: Regimen A tavo-EP
tavo-EP on Days 1, 8, 15 every 6 weeks.
Addendum: Regimen B tavo EP
tavo-EP on Days 1, 5, 8 every 6 weeks.

Who it enrols

Adult patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma, ECOG 0-2, and adequate organ function. Prior therapy allowed but must be washed out.

Endpoints

Primary

Best Overall Objective Response Rate by Modified 'Skin' RECISTWeek 48

Secondary

Percentage of Participants With Adverse Events and Serious Adverse EventsUp to 30 days after last dose
Median Overall SurvivalUp to 30 months
Objective Response Rate by Immune Related Response CriteriaWeek 48
Duration of Objective ResponseUp to 29.7 months
Time to First Objective ResponseUp to 29.7 months
Median Progression Free SurvivalUp to 29.7 months
Regression Rate of Treated and Untreated LesionsUp to End of Study

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