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)
Condition: 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
MeSH terms: Carcinoma; Neuroendocrine Tumors; Carcinoma, Neuroendocrine
Intervention: PDR001
Intervention description: PDR001 was administered at a dose of 400 mg via intravenous infusion once every 4 weeks (Q4W). PDR001 was administered on Day 1 of every cycle. Each cycle was 28 days.
Intervention MeSH terms: Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced or metastatic; NET; pNET; GI NET; thoracic NET; GEP-NEC

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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