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
The purpose of this study is to study 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 GEP-NEC.
Neuroendocrine Tumors of Pancreatic, GI, Thoracic, GEP-NEC
● 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 received prior treatment for advanced disease:
● Well-differentiated NET group:
● Thoracic (lung and thymus origin) cohort:
● Thymus origin: at least one prior systemic therapy according to investigator’s choice.
● Lung origin: at least one prior systemic therapy is required, which must include everolimus.
● GI cohort: at least two prior systemic regimens, which must include everolimus. Prior systemic therapies may include: somatostatin analogs, PRRT, and/or chemotherapy.
● pNET cohort: at least two prior systemic regimens, which must include everolimus or sunitinib. Prior systemic therapies may include: somatostatin analogs, PRRT, and/or chemotherapy.
Note: For well-differentiated NET, prior treatment with interferon alpha is allowed provided that it is not the last treatment received prior to study entry
● Poorly-differentiated GEP-NEC group: At least one prior chemotherapy regimen according to Investigator’s choice.
18 - 100
Healthy Volunteers Needed
Duration of Participation
You will receive the study drug until disease worsens, unacceptable toxicity, start of a new anti-neoplastic therapy, withdrawal of consent, physician’s decision, lost to follow-up. If you are no longer receiving treatment, you will be followed until completion of safety or efficacy follow-up, whichever is last.
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