Study of 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)
Completed · Phase 2
Conditions studied: 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
In brief
This study aimed 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 progressed on prior treatment.
Key facts
- Study ID
- NCT02955069
- Run by
- Novartis Pharmaceuticals
- People needed
- 116
- Starts
- 2017-02-14
- Expected to finish
- 2020-05-13
- Last updated by the study team
- 2021-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 depended 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 may not qualify 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.
- Peptide Radionuclide Receptor Therapy (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 Programmed Death-1 (PD-1) or Programmed Death-Ligand 1 (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.
- Other inclusion/exclusion criteria might apply
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- Rocky Mountain Cancer Centers SC-2 — Denver, Colorado, United States
- H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- University of TX MD Anderson Cancer Center — Houston, Texas, United States
- Novartis Investigative Site — St Leonards, New South Wales, Australia
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Lyon, France
- Novartis Investigative Site — Marseille, France
- Novartis Investigative Site — Toulouse, France
- Novartis Investigative Site — Erlangen, Germany
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — Mainz, Germany
- Novartis Investigative Site — Marburg, Germany
- Novartis Investigative Site — Bologna, BO, Italy
- Novartis Investigative Site — Meldola, FC, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Roma, RM, Italy
Full record on ClinicalTrials.gov
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