J1798: A Phase 2 Clinical Trial of Entinostat in Combination with Nivolumab for Patients with Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the safety and effectiveness of entinostat plus nivolumab in patients with unresectable or metastatic biliary tract cancer or metastatic or unresectable pancreatic cancer, who have progressed after one or two lines of prior therapy.
1.Patients must have histologically or cytologically confirmed cholangiocarcinoma or pancreatic cancer that is metastatic or unresectable and has progressed despite standard therapy or is intolerant of therapy; 1 or 2 prior chemotherapy regimens in the metastatic setting or progression less than 6 months from the completion of adjuvant chemotherapy;2.in good physical condition, organ function and blood counts; 3.have measurable disease; 4.have biopsiable disease; 5. not currently pregnant and if of childbearing age both males and females must be willing to use at least 1 method of birth control; no previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways; 6.known interstital lung disease;
This is a Phase 2 study that will evaluated the effectiveness of Entinostat in combination with Nivolumab. Entinostat is oral pill taken once a week and Nivolumab is IV once every 2 weeks.
03/05/2019 05:03 AM