A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

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Trial Profile

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2016

At a glance

  • Drugs Talimogene laherparepvec (Primary) ; Sargramostim
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTiM
  • Sponsors BioVex

    • Most Recent Events

    • 18 Dec 2015 Results published in an Amgen media release.
    • 18 Dec 2015 According to an Amgen media release, the European Commission has approved talimogene laherparepvec (IMLYGIC) for the treamtent of adults with unresectable metastatic melanoma. The approval was based on exploratory subgroup analysis from this trial.
    • 16 Nov 2015 Data from this trial will be presented at the 12th International Congress of the Society for Melanoma Research (SMR), as per Amgen media release.
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