A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers

A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers

Study Name
  A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers
Study Center
Institution Name
  Moffitt Cancer Center
Institution Address
  12902 Magnolia Drive
City
  Tampa
State
  Florida
Zip Code
  33606
Website
  https://www.moffitt.org
Study Contacts
Principal Investigator
  Nishi Kothari, MD
P.I. Phone
  (813) 745-7229
P.I. Email
  nishi.kothari@moffitt.org
Study Coordinator
  Marjorie Brelsford
Study Coordinator Phone
  (813) 745-6704
Study Coordinator Email
  Marjorie.Brelsford@moffitt.org
OVERVIEW – in layman’s terms (150 words max)
  The purpose of this study is to test the efficacy of the immunotherapy agent nivolumab in patients with advanced, refractory biliary cancers (intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer). Patients will be evaluated for progression-free survival, overall survival and response rate.
Enrollment
  34
Study Start Date
  09/19/2016
Estimated Completion Date
  09/30/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
 
  • The response rate of nivolumab (immunotherapy) in advanced biliary tract cancers after someone has progressed through standard treatment
Inclusion Criteria – Patients Must:
 
  • Have a biopsy confirmed diagnosis of biliary tract cancer
  • Have had at least one but no more than 3 prior treatments for the disease
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
 
  • CT scan
  • Biopsy of tumor if past biopsy sample is not available
POTENTIAL SIDE-EFFECTS – in layman’s terms
 
  • Diarrhea, liver problems, thyroid problems, lung inflammation

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