Trial · NCT02936752
Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
NCT02936752, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2024-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents. Trials, record NCT02936752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02936752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
- NCT number
- NCT02936752
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Entinostat, Pembrolizumab
- First posted
- 2016-10-18
- Last updated
- 2025-03-25
- Results first posted
- 2024-10-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Entinostat Given in Combination With Pembrolizumab | Up to 42 days | Toxicities will be tabulated and graded according to the Common Terminology Criteria for Adverse Events version 5. Dose-limiting toxicities will be assessed after the first 2 cycles of combined therapy. Presented are the counts of participants that experienced DLT in the period up to 42 days. |
| Secondary | Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Up to 6 months after the last dose of entinostat in combination with pembrolizumab ((treatment period: Up to 3, 21-day cycles) | Will be defined by the modified International Working Group 2006. Rates of CR, PR and HI will be summarized separately by cohort and reported with an exact 95% confidence interval. Upon results entry- best response to combination therapy (number of patients \[%\]; response assessment after 3 cycles) is presented as counts of the best response. |
| Secondary | Median Progression-free Survival | Assessed for up to 10 months after the last dose of entinostat in combination with pembrolizumab (treatment period: Up to 3, 21-day cycles) | Median progression-free survival (PFS) is being reported as the median time with the full range. The outcome was updated at the time of results entry to include the correct presentation of the data and the updated time frame for longest PFS follow up time. |
| Other | Median Response Duration for Responders | Up to 6 months after the last dose of entinostat in combination with pembrolizumab | Median response duration for responders will be determined. |
| Other | Median Time of Progression to Acute Myeloid Leukemia | Up to 6 months after the last dose of entinostat in combination with pembrolizumab | Median time of progression to acute myeloid leukemia will be determined. |
| Other | Median Overall Survival | From start of study to death, assessed for up to 6 months after the last dose of entinostat in combination with pembrolizumab | Will be reported with a 95% confidence interval. |
| Other | 1-year Overall Survival | From start of study to death, assessed for up to 1 year | Will be reported with a 95% confidence interval. |
| Other | 2-year Overall Survival | From start of study to death, assessed for up to 2 years | Will be reported with a 95% confidence interval. |
| Other | Dynamic Quantitative Change in Proportion of Myeloid-derived Suppressor Cells (MDSCs) in Bone Marrow With Combined Therapy, Assessed by Flow Cytometry | Baseline up to 1 year | Will correlate with any observed clinical responses. Will be estimated using mixed effects models to take into account the within-patient correlation. Likelihood ratio tests will be performed to confirm if random intercepts and slopes are necessary in the model. The fixed effect for change in MDSCs over time will be evaluated for significance. The variability in the rate of change in MDSCs across patients will also be examined. The association between the clinical outcome and a meaningful reduction in MDSCs, which will be defined after a review of the data, will be assessed with the chi-square test. The quantity of MDSCs at baseline and during treatment as continuous variables can also be compared between responding and non-responding patients using a t-test or Mann-Whitney U-Test, if more appropriate. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Entinostat Given in Combination With Pembrolizumab | Up to 42 days | 13 participants were eligible for dose escalation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Up to 6 months after the last dose of entinostat in combination with pembrolizumab ((treatment period: Up to 3, 21-day cycles) | All those enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival | Assessed for up to 10 months after the last dose of entinostat in combination with pembrolizumab (treatment period: Up to 3, 21-day cycles) | All participants | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Median Response Duration for Responders | Up to 6 months after the last dose of entinostat in combination with pembrolizumab | |||
| OTHER_PRE_SPECIFIED | Median Time of Progression to Acute Myeloid Leukemia | Up to 6 months after the last dose of entinostat in combination with pembrolizumab | |||
| OTHER_PRE_SPECIFIED | Median Overall Survival | From start of study to death, assessed for up to 6 months after the last dose of entinostat in combination with pembrolizumab | |||
| OTHER_PRE_SPECIFIED | 1-year Overall Survival | From start of study to death, assessed for up to 1 year | |||
| OTHER_PRE_SPECIFIED | 2-year Overall Survival | From start of study to death, assessed for up to 2 years | |||
| OTHER_PRE_SPECIFIED | Dynamic Quantitative Change in Proportion of Myeloid-derived Suppressor Cells (MDSCs) in Bone Marrow With Combined Therapy, Assessed by Flow Cytometry | Baseline up to 1 year |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Entinostat Given in Combination With Pembrolizumab | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 1 | Participants | ||
| Maximum Tolerated Dose of Entinostat Given in Combination With Pembrolizumab | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 2 | Participants | ||
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL1 | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL2 | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL1 | Partial Response (PR) | 0 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL2 | Partial Response (PR) | 0 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL1 | Stable Disease (SD) | 8 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL2 | Stable Disease (SD) | 3 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL1 | Progressive Disease (PD) | 5 | Participants | |
| Overall Response Rate (Complete Response [CR], Partial Response [PR], Hematologic Improvement [HI]) | Treatment (Entinostat, Pembrolizumab) DL2 | Progressive Disease (PD) | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 22 | |
| Overall Study | STARTED | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 16 | |
| Overall Study | COMPLETED | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 6 | |
| Overall Study | NOT COMPLETED | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 3 |
Source ClinicalTrials.gov
Adverse events422
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 | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 11 | 22 | 38 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 3 | 6 | 8 |
| other | blood in sputum | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 0 | 22 | 0 |
| other | blood in sputum | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 1 | 6 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 1 | 22 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 1 | 6 | 1 |
| other | Hematemesis | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 1 | 22 | 1 |
| other | Hematemesis | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 0 | 6 | 0 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 1 | 22 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 0 | 6 | 0 |
1 to 10 of 422Source ClinicalTrials.gov
See all 422 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 4 | 22 |
| Total, all-cause mortality | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 2 | 6 |
| Total, other adverse events | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 22 | 22 |
| Total, other adverse events | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 6 | 6 |
| Total, serious adverse events | Treatment (Entinostat, Pembrolizumab) Dose Level 1 | 12 | 22 |
| Total, serious adverse events | Treatment (Entinostat, Pembrolizumab) Dose Level 2 | 5 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38036712 | 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 |
|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Entinostat, Pembrolizumab) Dose Level 1 vs Treatment (Entinostat, Pembrolizumab) Dose Level 2: deaths from any cause | Trial comparisons |
| Treatment (Entinostat, Pembrolizumab) Dose Level 1 vs Treatment (Entinostat, Pembrolizumab) Dose Level 2: Maximum Tolerated Dose of Entinostat Given in Combination With Pembrolizumab | Trial comparisons |
| Treatment (Entinostat, Pembrolizumab) Dose Level 1 vs Treatment (Entinostat, Pembrolizumab) Dose Level 2: 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.
GET https://conductscience.org/api/trials/v1/NCT02936752
GET https://conductscience.org/api/trials/v1/NCT02936752/events?page=2