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A phase 3 trial of Talimogene laherparepvec and Sargramostim in Melanoma, run by BioVex Limited, completed.
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma is a phase 3 interventional study registered as NCT00769704 by BioVex Limited, with 437 participants recorded, started 2009-04 and reaching its primary completion in 2013-02. Interventions recorded: Talimogene laherparepvec, GM-CSF. Conditions recorded: Melanoma.
Linked to the drug Talimogene laherparepvec because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
437 enrolled.
95% CI 0.0 to 4.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication · 95% CI 12.1 to 20.5
Source95% CI 16.0 to 23.7; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication · 95% CI 19.5 to 29.6
Source95% CI 1.9 to 9.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication · 95% CI 21.4 to 31.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Durable Response Rateprimary | GM-CSF | 141 | 2.1% | - | <0.0001 | link |
| Talimogene Laherparepvec | 295 | 16.3% | ||||
| Overall Survival | GM-CSF | 141 | 18.9 months | 0.79 (0.62 to 1) | 0.0511 | link |
| Talimogene Laherparepvec | 295 | 23.3 months | ||||
| Objective Response Rate | GM-CSF | 141 | 5.7% | - | <0.0001 | link |
| Talimogene Laherparepvec | 295 | 26.4% |
Shares Talimogene laherparepvec, Amgen, Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Talimogene laherparepvec, Amgen, Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Sargramostim and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.