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NCT00769704 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
A Phase 3 study of Melanoma, sponsored by BioVex Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 437
- Enrollment target
- 20
- Study locations
NCT00769704: Completed Phase 3 study of Melanoma, sponsored by BioVex Limited.
NCT00769704 is a Phase 3 study of Melanoma that has completed, run by BioVex Limited. The registered enrollment target is 437 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769704, a Phase 3 study of Melanoma, has completed, sponsored by BioVex Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 437 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in
Conditions Studied
Interventions
- BIOLOGICAL GM-CSF
- BIOLOGICAL Talimogene laherparepvec
Study Locations (20)
Florida
- Baptist Cancer Institute - Jacksonville
- Lakeland Regional Cancer Center - Lakeland
- University of Miami - Miami
- Mount Sinai Medical Center CCOP - Miami Beach
- MD Anderson Cancer Center Orlando - Orlando
- H. Lee Moffitt Cancer Center - Tampa
- Palm Beach Cancer Institute - West Palm Beach
California
- University of California San Diego, Moores Cancer Center - La Jolla
- UCLA Medical Center - Los Angeles
- San Francisco Oncology Associates - San Francisco
- Northern California Melanoma Center, St. Mary's Medical Center - San Francisco
- John Wayne Cancer Institute - Santa Monica
- Redwood Regional Medical Group Inc, North Bay Melanoma Program - Sebastopol
Illinois
- Rush University Medical Center - Chicago
- Cancer Care Center at Lutheran General Hospital - Park Ridge
Arizona
- University of Arizona Cancer Center - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- University of Colorado Cancer Center - Aurora
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2009-04 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT00769704 record still lists
NCT00769704 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which GM-CSF is the first listed.
NCT00769704 names 20 study sites across 8 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00769704 about?
NCT00769704 is a clinical study titled "Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma". 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 b...
What is the current status of trial NCT00769704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 437 participants. The study started on 2009-04. Estimated completion is 2014-09.
What conditions does trial NCT00769704 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT00769704?
The interventions under investigation include: GM-CSF (BIOLOGICAL), Talimogene laherparepvec (BIOLOGICAL).
Who is sponsoring clinical trial NCT00769704?
This trial is sponsored by BioVex Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00769704 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00769704's enrollment target sits among peer trials
437 43rd of 266 higher than 224 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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