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

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 6, 2017

Primary Completion Date

November 20, 2020

Study Completion Date

November 20, 2020

Conditions
Metastatic CholangiocarcinomaCholangiocarcinomaPancreatic CancerMetastatic Pancreatic CancerUnresectable Pancreatic CancerUnresectable Cholangiocarcinoma
Interventions
DRUG

Entinostat

Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).

DRUG

Nivolumab

After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).

DRUG

Entinostat

Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).

DRUG

Nivolumab

After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
collaborator

Syndax Pharmaceuticals

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT03250273 - A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter