A global, randomized Phase 3 registration trial with CRS-207 in combination with standard-of-care chemotherapy in patients with unresectable Malignant Pleural Mesothelioma (MPM)

Trial Profile

A global, randomized Phase 3 registration trial with CRS-207 in combination with standard-of-care chemotherapy in patients with unresectable Malignant Pleural Mesothelioma (MPM)

Planning
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2016

At a glance

  • Drugs CRS 207 (Primary)
  • Indications Mesothelioma
  • Focus Registrational; Therapeutic Use
  • Sponsors Aduro BioTech
  • Most Recent Events

    • 21 Nov 2016 Status changed from suspended to planning, as according to an Aduro Biotech media release the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.
    • 24 Oct 2016 Status changed from planning to suspended, as according to an Aduro Biotech media release, company has received notice from the U.S. FDA that the trials based on LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical hold to pause new patient enrollment as a metastatic pancreatic cancer patient with gastrointestinal symptoms tested positive for Listeria. Aduro is working with the FDA to lift the partial hold so as to resume new patient enrollment in its LADD.
    • 12 Aug 2015 New trial record
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