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Clinical Trial 19063
Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
Phase of Study: Phase II
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
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.
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.