| 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
|
