IRB #

STUDY00016689

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

Principal Investigator

Rodney Pommier

Study Purpose

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.

Medical Condition(s)

Neuroendocrine Tumors of Pancreatic, GI, Thoracic, GEP-NEC

Eligibility 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 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.

Age Range

18 - 100

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

OHSU Knight Cancer Institute Information line 503-494-1080 trials@ohsu.edu

Sponsor

Novartis

Recruitment End

12/31/2030

Compensation Provided

No


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