CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Entinostat +3 moredrug
Likely dose
Entinostat 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03250273
NCT03250273Phase 2Completed
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A Phase 2 Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 15, 2017·Updated May 28, 2025

In Brief

A Phase 2 clinical trial evaluating Entinostat and Nivolumab for Metastatic Cholangiocarcinoma and 5 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cholangiocarcinoma, Cholangiocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer, Unresectable Cholangiocarcinoma
CountriesUnited States
CollaboratorsSyndax Pharmaceuticals, Bristol-Myers Squibb, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartNov 6, 2017
Primary CompletionNov 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.9 years ago

Interventions

Entinostatdrug

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).

Nivolumabdrug

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

Entinostatdrug

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).

Nivolumabdrug

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