NCT00769704

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: BioVex Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Talimogene laherparepvec	Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
BIOLOGICAL	GM-CSF	125 µg/m² subcutaneous injection

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-02-01
• Completion: 2014-09-01
• First posted: 2008-10-09
• Last updated: 2016-07-13
• Results posted: 2015-12-17

Locations

83 sites across 4 countries: United States, Canada, South Africa, United Kingdom