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

COMPLETEDPHASE2

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

NCT03250273•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years.
•2. Have histologically or cytologically proven cholangiocarcinoma or adenocarcinoma of the pancreas that is metastatic or unresectable.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•4. Life expectancy of greater than 12 weeks.
•5. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
•6. Woman of child bearing potential must have a negative pregnancy test.
•7. Must have progressive measurable disease.
•8. Must have an accessible non-bone tumor that can be biopsied.
•9. Must use acceptable form of birth control while on study.
•10. Willing to provide tissue and blood samples.
+1 more criteria

Exclusion Criteria

•1. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 3 weeks prior to trial registration
•2. Prior treatment with epigenetic therapy (such as entinostat, panobinostat, vorinostat, romidepsin, 5-azacitidine, or decitabine)
•3. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
•4. Hypersensitivity reaction to any monoclonal antibody.
•5. History of any autoimmune disease: inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis). Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
•6. Have significant and/or malignant pleural effusion
•7. Has a pulse oximetry \< 92% on room air.
•8. Known history or evidence of brain metastases.
•9. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
•10. Are pregnant or breastfeeding.
+8 more criteria

Locations (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

November 6, 2017

Primary Completion Date

November 20, 2020

Completion Date

November 20, 2020

Last Updated

May 28, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic CholangiocarcinomaCholangiocarcinomaPancreatic CancerMetastatic Pancreatic CancerUnresectable Pancreatic CancerUnresectable Cholangiocarcinoma

Interventions

Entinostat

DRUG

Nivolumab

DRUG

Entinostat

DRUG

Nivolumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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