A phase 3 trial to evaluate CMB305 monotherapy in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma

Trial Profile

A phase 3 trial to evaluate CMB305 monotherapy in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma

Planning
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2017

At a glance

  • Drugs CMB 305 (Primary)
  • Indications Soft tissue sarcoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Immune Design
  • Most Recent Events

    • 18 Oct 2017 New trial record
    • 16 Oct 2017 According to an Immune Design media release, this trial will support a Biologics License Application (BLA) for CMB305 for the treatment of patients with synovial sarcoma. If the PFS endpoint is successful, the FDA offered that it may support full approval of CMB305. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed.
    • 16 Oct 2017 Immune Design intends to start the study in mid-2018, according to a company media release.
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