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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

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

    • Most Recent Events

    • 28 Jun 2023 According to a HiFiBiO media release, Dr. Andtbacka was the lead investigator for this trial.
    • 17 Sep 2019 According to an Amgen media release, data from subgroup analysis form this trial will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, Sept. 27-Oct. 1, 2019.
    • 04 Jun 2019 Results of post hoc analysis (n=436), assessing progression free survival, presented at the 55th Annual Meeting of the American Society of Clinical Oncology.

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