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NCT01368276 · ClinicalTrials.gov registry record · Phase 3
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
A Phase 3 study, sponsored by BioVex Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT01368276: Completed Phase 3 study, sponsored by BioVex Limited.
NCT01368276 is a Phase 3 study that has completed, run by BioVex Limited. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01368276, a Phase 3 study, has completed, sponsored by BioVex Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator. A serious AE is one that meets one or more of the following criteria
Interventions
- BIOLOGICAL Talimogene Laherparepvec
- DRUG Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01368276 record still lists
NCT01368276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Talimogene Laherparepvec is the first listed.
NCT01368276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01368276 about?
NCT01368276 is a clinical study titled "An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma". 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.
What is the current status of trial NCT01368276?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2010-10. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01368276?
The interventions under investigation include: Talimogene Laherparepvec (BIOLOGICAL), Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) (DRUG).
Who is sponsoring clinical trial NCT01368276?
This trial is sponsored by BioVex Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01368276's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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