Avelumab in G2-3 NET

Official Title

A Phase II Study of Avelumab in Unresectable/Metastatic, Progressive Grade 2-3 Neuroendocrine Tumours

Summary:

This is a single-centre, single-arm, open-label, phase II trial to evaluate the efficacy and safety of avelumab in subjects with unresectable or metastatic, Grade 2-3, well-differentiated neuroendocrine.tumour.

Trial Description

Primary Outcome:

  • Overall response rate (ORR)
Secondary Outcome:
  • Disease control rate (DCR)
  • Duration of response
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Rates of treatment-emergent adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
  • ORR by irRECIST version 1.1
  • DCR by irRECIST version 1.1
  • Duration of response by irRECIST version 1.1
  • PFS by irRECIST version 1.1
  • OS at 1 year
  • OS at 2 years
  • PFS at 1 year
  • PFS at 2 years

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