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)



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:February 14, 2017
End Date:April 3, 2020

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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, 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.


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 depends 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.

- 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 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.
We found this trial at
12
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Houston, Texas
Principal Investigator: James C. Yao
Phone: 713-792-2828
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Lakshmi Rajdev
Phone: 718-862-6868
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jonathan Strosberg
Phone: 888-663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Boston, Massachusetts 02115
Principal Investigator: Jennifer Ang Chan
Phone: +1 617 643 1820
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1800 North Williams Street
Denver, Colorado 80218
Principal Investigator: Allen Cohn
Phone: 303-285-5018
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Daneng Li
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Lexington, Kentucky 40536
Principal Investigator: Lowell B. Anthony
Phone: 859-323-5785
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Nitya Raj
Phone: 212-639-3112
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
Principal Investigator: Rodney Pommier
Phone: 503-418-3652
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Timothy Hobday
Phone: 855-776-0015
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Francisco, California 94143
Principal Investigator: Emily Bergsland
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St Leonards, New South Wales 2065
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