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A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

Study Name
A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
ClinicalTrials.gov Identifier (if applicable)
NCT03250273
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Immunotherapy
  • Other Novel Therapy
Study Center
Institution Name
Johns Hopkins University
Institution Address
401 N. Broadway
City
Baltimore
State
Maryland
Zip Code
21287
List additional Institutions (include address, phone number, and website)
Referral nurses Jane Zorzi (jzorzi1@jhmi.edu) and Susan Sartorius-Melganthaler (sartosu@jhmi.edu) will help look over records and determine if patients are eligible
Study Contacts
Principal Investigator
Nilofer Azad
P.I. Phone
(410) 955-8893
P.I. Email
nazad2@jhmi.edu
List additional Principal Investigators (include phone number and email)
Marina Baretti MD
mbarett1@jhmi.edu
Study Coordinator
Susan Sartorius-Merganthaler
Study Coordinator Phone
(410) 614-3644
Study Coordinator Email
sartosu@jhmi.edu
OVERVIEW – in layman’s terms (150 words max)
This is a trial of combining a HDAC inhibitor and a PD1 inhibitor (immunotherapy drug) to make cholangiocarcinoma more sensitive to immunotherapy. This is based on laboratory data that shows HDAC inhibitors can make tumors more sensitive to immunotherapy.
Enrollment
27
Study Start Date
10/23/2017
Estimated Completion Date
12/31/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • to improve tumor shrinkage and control rates with treatment
Inclusion Criteria – Patients Must:
  • have had one prior standard therapy
Exclusion Criteria – Patients Must NOT:
  • have an autoimmune disease that has needed systemic treatment in the last 2 years (steroids)
  • have brain metastases
  • prior immunotherapy with a PD1inhibitor or a drug similar to that
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