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A Phase II Study to Investigate the Maintenance Therapy of OSE-2101 (Tedopi) Alone or in Combination with Nivolumab Versus Standard of Care Maintenance Treatment with Folfiri in Patients with Locally Advanced or Metastatic Pancreatic Cancer

Trial Profile

A Phase II Study to Investigate the Maintenance Therapy of OSE-2101 (Tedopi) Alone or in Combination with Nivolumab Versus Standard of Care Maintenance Treatment with Folfiri in Patients with Locally Advanced or Metastatic Pancreatic Cancer

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Nov 2018

At a glance

  • Drugs Nivolumab (Primary) ; OSE 2101 (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Pancreatic cancer
  • Focus Therapeutic Use
  • Acronyms TEDOPaM
  • Most Recent Events

    • 20 Nov 2018 Status changed from planning to not yet recruiting, according to an OSE Immunotherapeutics media release.
    • 20 Nov 2018 According to an OSE Immunotherapeutics media release, the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic Committee (CPP) has approved the IND application to initiate this GERCOR sponsored study. Opening of sites for the study is expected in early 2019.
    • 10 Oct 2018 According to an OSE Immunotherapeutics media release, the company and GERCOR has submitted the IND application to initiate this trial.The IND application has been submitted in France to the ANSM (the French National Agency for Medicines and Health Products Safety) and to the central Ethics Committee by the oncology cooperative group GERCOR, who is sponsoring the clinical trial as part of PRODIGE intergroup.The Company expects activation of the trial and opening of clinical centers in early 2019.
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