CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Talimogene Laherparepvec +1 morebiological
Likely dose
Talimogene Laherparepvec 4 mLfrom 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/NCT01368276
NCT01368276Phase 3Completed
CompareCT.gov

An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05

BioVex Limited·interventional·Posted Jun 7, 2011·Updated Dec 18, 2015

In Brief

A Phase 3 clinical trial evaluating Talimogene Laherparepvec and Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) for Melanoma. Completed, enrolled 31 participants across 10 sites in 2 countries.

Detailed Summary

The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2011
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.1 years ago

Interventions

Talimogene Laherparepvecbiological

Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)drug

125 µg/m² subcutaneous injection