NCT03250273

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

A Phase 2 Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an open-label, two-arm study of entinostat plus nivolumab in patients with unresectable or metastatic cholangiocarcinoma (CCA) or pancreatic ductal adenocarcinoma (PDAC).

Conditions

• Metastatic Cholangiocarcinoma
• Cholangiocarcinoma
• Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Unresectable Pancreatic Cancer
• Unresectable Cholangiocarcinoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-11-06
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2017-08-15
• Last updated: 2025-05-28
• Results posted: 2021-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study