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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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 Tumors 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

Keywords

Well-differentiated Non-functional NET of Thoracic Origin Well-differentiated Non-functional NET of Gastrointestinal Origin Well-differentiated Non-functional NET of Pancreatic Origin Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma Advanced or metastatic NET pNET GI NET thoracic NET GEP-NEC Carcinoma Neuroendocrine Tumors Carcinoid Tumor Carcinoma, Neuroendocrine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically confirmed, advanced (unresectable or metastatic):
  • Well-differentiated (G1 or G2) based on local pathology report, non-functional neuroendocrine tumor of GI, pancreatic or thoracic (including lung and thymus) origin.
  • Poorly-differentiated GEP-NEC based on local pathology report
  • No active symptoms related to carcinoid syndrome during the last 3 months prior to start of study treatment.
  • Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin for NET and for GEP-NEC
  • Tumor biopsy material must be provided for all patients for the purpose of biomarker analysis
  • Radiological documentation of disease progression:
  • Well-differentiated NET group: Disease progression while on/or after the last treatment, and this progression must have been observed within 6 months prior to start of study treatment (i.e. maximum of 24 weeks from documentation of progression until study entry). Disease must show evidence of radiological disease progression based on scans performed not more than 12 months apart.
  • Poorly-differentiated GEP-NEC group: Disease progression while on or after prior treatment.

You CAN'T join if...

  • Well-differentiated grade 3 neuroendocrine tumors; poorly-differentiated neuroendocrine carcinoma of any origin (other than GEP-NEC); including NEC of unknown origin, adenocarcinoid, and goblet cell carcinoid
  • Pretreatment with interferon as last treatment prior to start of study treatment.
  • Prior treatment for study indication with:
  • Antibodies or immunotherapy within 6 weeks before the first dose of study treatment.
  • PRRT administered within 6 months of the first dose.
  • Systemic antineoplastic therapy
  • Tyrosine kinase inhibitors within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
  • Prior PD-1- or PD-L1-directed therapy.
  • Cryoablation, radiofrequency ablation, or trans-arterial embolization of hepatic metastases
  • History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.

Locations

  • University of California San Francisco in progress, not accepting new patients
    San Francisco, California, 94115, United States
  • City of Hope National Medical Center accepting new patients
    Duarte, California, 91010, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02955069
Phase
Phase 2
Lead Scientist
Emily Bergsland
Study Type
Interventional
Last Updated
November 15, 2017