CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 437 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/NCT00769704
NCT00769704Phase 3Completed
CompareCT.gov

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

BioVex Limited·interventional·Posted Oct 9, 2008·Updated Jul 13, 2016

In Brief

A Phase 3 clinical trial evaluating Talimogene laherparepvec and GM-CSF for Melanoma. Completed, enrolled 437 participants across 83 sites in 4 countries.

Detailed Summary

The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesCanada, South Africa, United Kingdom, United States
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2008
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.7 years ago

Interventions

Talimogene laherparepvecbiological

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

GM-CSFbiological

125 µg/m² subcutaneous injection