Clinical Trial 19063

Cancer Type: Gastrointestinal Tumor
Interventions:PDR001

Study Type: Treatment
Phase of Study: Phase II
Investigators:


    Overview

    Study 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

    Summary

    This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin.

    Objective

    Primary Objective: - To estimate the antitumor activity (assessed as ORR per RECIST 1.1) of PDR001 as a single agent in patients with non-functional NET. Key Secondary Objective: - To estimate efficacy (DoR per RECIST 1.1) of PDR001. Secondary Objectives: - To assess the safety and tolerability of PDR001 in patients with non-functional NET. - To evaluate additional efficacy parameters per RECIST 1.1 and per Immune Response Criteria irRECIST as well as 1-year and 2-year OS rate. - To evaluate biochemical response to treatment (based on CgA and NSE). - To characterize the pharmacokinetics of PDR001 with 400 mg flat dose Q4W. - To characterize patient's health-related quality of life with PDR001. - To evaluate the prevalence and incidence of immunogenicity.

    Inclusion Criteria

  • Pathologically confirmed, well-differentiated advanced, non-functional neuroendocrine tumor of GI, pancreatic or thoracic origin.
  • No history of, and no active symptoms related to carcinoid syndrome.
  • Must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin.
  • Must be willing to provide biopsy material.
  • Radiological documentation of disease progression while on/or after the last treatment; progression must have been observed within 6 months prior to start of study treatment.

  • Exclusion Criteria

  • Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma.
  • 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 chemoembolization 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.