Trials / Completed
CompletedNCT01368276
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- BioVex Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Talimogene Laherparepvec | Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection |
| DRUG | Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) | 125 µg/m² subcutaneous injection |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2011-06-07
- Last updated
- 2015-12-18
- Results posted
- 2015-12-18
Locations
10 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01368276. Inclusion in this directory is not an endorsement.