Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumours of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

Official Title

An Open Label Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumours of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), That Have Progressed on Prior Treatment EUDRACT 2016-002522-36

Summary:

This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumours of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that have progressed on prior treatment.

Trial Description

Primary Outcome:

  • Overall response rate
Secondary Outcome:
  • Duration of response
  • Disease Control
  • Time to response
  • Progression-free survival
  • Overall survival
  • Immune Response Criteria by irRECIST(immune response overall response rate)
  • Immune Response Criteria by irRECIST (immune response duration of response)
  • Immune Response Criteria by irRECIST (immune response time to response)
  • Immune Response Criteria by irRECIST (immune response disease control rate)
  • Patient's health-related quality of life
  • Biochemical response

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society