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)

Description

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.

Study Start Date

February, 14 2017

Estimated Completion Date

December 2019

Interventions

  • Drug: PDR001

Study ID

Novartis -- CPDR001E2201

Status

Recruiting

Trial ID

NCT02955069

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

110

Sponsor

Novartis

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (42)

Study Location Distance Name Phone Email
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Christine Ganser 617-643-1820 Christine_Ganser@DFCI.HARVARD.EDU
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Christine Ganser 617-643-1820 Christine_Ganser@DFCI.HARVARD.EDU
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Christine Ganser 617-643-1820 Christine_Ganser@DFCI.HARVARD.EDU
Montefiore Medical Center - The Bronx, New York 176.6 miles Prena Etchen 718-862-6868 pzagreda@montefiore.org
Montefiore Medical Center - The Bronx, New York 176.6 miles Prena Etchen 718-862-6868 pzagreda@montefiore.org
Montefiore Medical Center - The Bronx, New York 176.6 miles Prena Etchen 718-862-6868 pzagreda@montefiore.org
Montefiore Medical Center - The Bronx, New York 176.6 miles Prena Etchen 718-862-6868 pzagreda@montefiore.org
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles Jennifer Lopez 212-639-3112 lopezcoj@mskcc.org
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles Jennifer Lopez 212-639-3112 lopezcoj@mskcc.org
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles Jennifer Lopez 212-639-3112 lopezcoj@mskcc.org
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles Jennifer Lopez 212-639-3112 lopezcoj@mskcc.org
University of Kentucky SC2 - Lexington, Kentucky 769.1 miles Jeri Reynolds 859-323-5785 jzreyn0@email.uky.edu
University of Kentucky SC2 - Lexington, Kentucky 769.1 miles Jeri Reynolds 859-323-5785 jzreyn0@email.uky.edu
University of Kentucky SC2 - Lexington, Kentucky 769.1 miles Jeri Reynolds 859-323-5785 jzreyn0@email.uky.edu
University of Kentucky SC2 - Lexington, Kentucky 769.1 miles Jeri Reynolds 859-323-5785 jzreyn0@email.uky.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles ClinicalTrials Referral Office 855-776-0015 None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles ClinicalTrials Referral Office 855-776-0015 None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles ClinicalTrials Referral Office 855-776-0015 None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles ClinicalTrials Referral Office 855-776-0015 None
H Lee Moffitt Cancer Center Research Institute - Tampa, Florida 1,178.7 miles Rebecca McKinney 888-663-3488 rebecca.mckinney@moffitt.org
H Lee Moffitt Cancer Center Research Institute - Tampa, Florida 1,178.7 miles Rebecca McKinney 888-663-3488 rebecca.mckinney@moffitt.org
H Lee Moffitt Cancer Center Research Institute - Tampa, Florida 1,178.7 miles Rebecca McKinney 888-663-3488 rebecca.mckinney@moffitt.org
H Lee Moffitt Cancer Center Research Institute - Tampa, Florida 1,178.7 miles Rebecca McKinney 888-663-3488 rebecca.mckinney@moffitt.org
MD Anderson Cancer CenterUniversity of Texas - Houston, Texas 1,609.9 miles None None None
MD Anderson Cancer CenterUniversity of Texas - Houston, Texas 1,609.9 miles None None None
MD Anderson Cancer CenterUniversity of Texas - Houston, Texas 1,609.9 miles None None None
MD Anderson Cancer CenterUniversity of Texas - Houston, Texas 1,609.9 miles None None None
Rocky Mountain Cancer Centers SC2 - Denver, Colorado 1,766.9 miles Katherine Schleich 303-285-5018 katherine.schleich@usoncology.com
Rocky Mountain Cancer Centers SC2 - Denver, Colorado 1,766.9 miles Katherine Schleich 303-285-5018 katherine.schleich@usoncology.com
Rocky Mountain Cancer Centers SC2 - Denver, Colorado 1,766.9 miles Katherine Schleich 303-285-5018 katherine.schleich@usoncology.com
Rocky Mountain Cancer Centers SC2 - Denver, Colorado 1,766.9 miles Katherine Schleich 303-285-5018 katherine.schleich@usoncology.com
OHSU Knight Cancer Institute - Portland, Oregon 2,538.3 miles Kate Rodman 503-494-3175 rodmank@ohsu.edu
OHSU Knight Cancer Institute - Portland, Oregon 2,538.3 miles Kate Rodman 503-494-3175 rodmank@ohsu.edu
OHSU Knight Cancer Institute - Portland, Oregon 2,538.3 miles Kate Rodman 503-494-3175 rodmank@ohsu.edu
OHSU Knight Cancer Institute - Portland, Oregon 2,538.3 miles Kate Rodman 503-494-3175 rodmank@ohsu.edu
City of Hope National Medical Center - Duarte, California 2,578.2 miles Blanca Herrera 626-256-4673 Ext. 85013 bherrera@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Blanca Herrera 626-256-4673 Ext. 85013 bherrera@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Blanca Herrera 626-256-4673 Ext. 85013 bherrera@coh.org
University of California San Francisco - San Francisco, California 2,698.0 miles Julie SudduthKlinger None Julie.Sudduth-Klinger@ucsf.edu
University of California San Francisco - San Francisco, California 2,698.0 miles Julie SudduthKlinger None Julie.Sudduth-Klinger@ucsf.edu
University of California San Francisco - San Francisco, California 2,698.0 miles Julie SudduthKlinger None Julie.Sudduth-Klinger@ucsf.edu
University of California San Francisco - San Francisco, California 2,698.0 miles Julie SudduthKlinger None Julie.Sudduth-Klinger@ucsf.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.