Trial · NCT03250273
A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
NCT03250273, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2021-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma. Trials, record NCT03250273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03250273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
- NCT number
- NCT03250273
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Metastatic Cholangiocarcinoma, Cholangiocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer, Unresectable Cholangiocarcinoma
- Interventions
- Entinostat, Nivolumab, Entinostat, Nivolumab
- First posted
- 2017-08-15
- Last updated
- 2025-05-28
- Results first posted
- 2021-12-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | 27 months | Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to clinical progression prior to post-baseline tumor assessments were considered as non-responders. |
| Secondary | Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) | 29 months | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. |
| Secondary | Overall Survival (OS) | 38 months | OS is defined as the duration of time from start of study treatment to time of death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. |
| Secondary | Overall Survival (OS) at 6 Months | 6 months | OS is defined as the proportion of subjects who are alive at 6 months. Estimation based on the Kaplan-Meier curve. |
| Secondary | Overall Survival (OS) at 12 Months | 12 months | OS is defined as the proportion of subjects who are alive at 12 months. Estimation based on the Kaplan-Meier curve. |
| Secondary | Overall Survival (OS) at 24 Months | 24 months | OS is defined as the proportion of subjects who are alive at 24 months. Estimation based on the Kaplan-Meier curve. |
| Secondary | Overall Survival (OS) at 36 Months | 36 months | OS is defined as the proportion of subjects who are alive at 36 months. Estimation based on the Kaplan-Meier curve. |
| Secondary | Duration of Response (DOR) | 27 months | Duration of response (DOR) will be calculated for subjects who achieve a best overall response of CR or PR. DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions. |
| Secondary | Progression Free Survival (PFS) at 6 Months | 6 months | PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.Estimation based on the Kaplan-Meier curve. |
| Secondary | Progression Free Survival (PFS) at 12 Months | 12 months | PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 12 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.Estimation based on the Kaplan-Meier curve. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | 27 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) | 29 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | 38 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) at 6 Months | 6 months | proportion of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) at 12 Months | 12 months | proportion of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) at 24 Months | 24 months | proportion of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) at 36 Months | 36 months | proportion of participants | NUMBER | |
| SECONDARY | Duration of Response (DOR) | 27 months | There were no responses (PR or CR) observed in Arm A; therefore, the number of analyzed participants is zero. 3 participants achieved response in Arm B. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) at 6 Months | 6 months | proportion of participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) at 12 Months | 12 months | proportion of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | Arm A - Cholangiocarcinoma | 0 | Participants | ||
| Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | ARM B - Pancreatic Cancer | 3 | Participants | ||
| Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) | Arm A - Cholangiocarcinoma | 5 | Participants | ||
| Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) | ARM B - Pancreatic Cancer | 19 | Participants | ||
| Overall Survival (OS) | Arm A - Cholangiocarcinoma | 6.378 | 95% Confidence Interval 3.748 to NA | months | |
| Overall Survival (OS) | ARM B - Pancreatic Cancer | 2.729 | 95% Confidence Interval 1.84 to 5.62 | months | |
| Overall Survival (OS) at 6 Months | Arm A - Cholangiocarcinoma | 0.538 | 95% Confidence Interval 0.326 to 0.891 | proportion of participants | |
| Overall Survival (OS) at 6 Months | ARM B - Pancreatic Cancer | 0.277 | 95% Confidence Interval 0.153 to 0.498 | proportion of participants | |
| Overall Survival (OS) at 12 Months | Arm A - Cholangiocarcinoma | 0.308 | 95% Confidence Interval 0.136 to 0.695 | proportion of participants | |
| Overall Survival (OS) at 12 Months | ARM B - Pancreatic Cancer | 0.138 | 95% Confidence Interval 0.056 to 0.343 | proportion of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Cholangiocarcinoma | 13 | |
| Overall Study | STARTED | ARM B - Pancreatic Cancer | 30 | |
| Overall Study | COMPLETED | Arm A - Cholangiocarcinoma | 11 | |
| Overall Study | COMPLETED | ARM B - Pancreatic Cancer | 18 | |
| Overall Study | NOT COMPLETED | Arm A - Cholangiocarcinoma | 2 | |
| Overall Study | NOT COMPLETED | ARM B - Pancreatic Cancer | 12 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A - Cholangiocarcinoma | 1 | 13 | 2 |
| other | Anemia | Blood and lymphatic system disorders | ARM B - Pancreatic Cancer | 9 | 30 | 14 |
| other | Hypothyroidism | Endocrine disorders | Arm A - Cholangiocarcinoma | 1 | 13 | 1 |
| other | Hypothyroidism | Endocrine disorders | ARM B - Pancreatic Cancer | 0 | 30 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm A - Cholangiocarcinoma | 2 | 13 | 2 |
| other | Constipation | Gastrointestinal disorders | ARM B - Pancreatic Cancer | 1 | 30 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arm A - Cholangiocarcinoma | 2 | 13 | 2 |
| other | Diarrhea | Gastrointestinal disorders | ARM B - Pancreatic Cancer | 3 | 30 | 4 |
| other | Dry lips | Gastrointestinal disorders | Arm A - Cholangiocarcinoma | 1 | 13 | 1 |
| other | Dry lips | Gastrointestinal disorders | ARM B - Pancreatic Cancer | 0 | 30 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Cholangiocarcinoma | 0 | 13 |
| Total, all-cause mortality | ARM B - Pancreatic Cancer | 1 | 30 |
| Total, other adverse events | Arm A - Cholangiocarcinoma | 12 | 13 |
| Total, other adverse events | ARM B - Pancreatic Cancer | 27 | 30 |
| Total, serious adverse events | Arm A - Cholangiocarcinoma | 4 | 13 |
| Total, serious adverse events | ARM B - Pancreatic Cancer | 3 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39532835 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA247886 | Transforming Human Pancreatic Cancer Into An Immunologic Disease | JAFFEE, ELIZABETH M. | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2021 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A - Cholangiocarcinoma vs ARM B - Pancreatic Cancer: Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) | Trial comparisons |
| Arm A - Cholangiocarcinoma vs ARM B - Pancreatic Cancer: Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | Trial comparisons |
| Arm A - Cholangiocarcinoma vs ARM B - Pancreatic Cancer: deaths from any cause | Trial comparisons |
| Arm A - Cholangiocarcinoma vs ARM B - Pancreatic Cancer: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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