Trial · NCT03765229
An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma
NCT03765229, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2024-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma. Trials, record NCT03765229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03765229
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma
- NCT number
- NCT03765229
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Melanoma
- Interventions
- Entinostat, Pembrolizumab
- First posted
- 2018-12-05
- Last updated
- 2024-01-10
- Results first posted
- 2024-01-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Conversions of Non-inflamed to Inflamed Melanoma | 3 weeks after start of treatment | Number of subjects with conversion from non-inflamed Tumor-infiltrating lymphocyte / Tumor-associated lymphocyte (TIL/TAL) absent before treatment to TIL/TAL present after treatment was assessed by histopathologic analysis. Representative 5-micron thick formalin fixed paraffin embedded sections collected from baseline and on-treatment (entinostat-alone, day 21 of the trial) were stained with hematoxylin and eosin on day 21 (on-treatment biopsy). |
| Secondary | Overall Response Rate | 9 weeks | Radiographic response will be measured by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria for Complete Response (CR), disappearance of all target lesions or Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. The Overall Response rate will be the percentage of subjects with CR or PR at 9 weeks after the start of treatment. |
| Secondary | Progression-Free Survival | 6 months | Progression Free Survival is measured as the rate of patients who are progression-free from the date of enrollment on study to the date of documented progression per RECIST 1.1. criteria or death. Per RECIST 1.1, Progressive Disease (PD), is a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat Combination | 9 weeks | Type of AEs that occur in subjects enrolled who receive at least one dose of therapy will be reported based on the NCI Common Terminology Criteria for Adverse Events v5.0 (NCI-CTCAE v.5.0). The NCI-CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Conversions of Non-inflamed to Inflamed Melanoma | 3 weeks after start of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate | 9 weeks | Subjects started to the study treatment and response evaluation per RECIST was completed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival | 6 months | Subjects who started the study treatment and tumor response was evaluated, median follow-up time 14.3 (2.5-36.8) months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat Combination | 9 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Conversions of Non-inflamed to Inflamed Melanoma | Single Arm: Entinostat + Pembrolizumab | Tumor-infiltrating lymphocyte increased | 3 | Participants | |
| Number of Conversions of Non-inflamed to Inflamed Melanoma | Single Arm: Entinostat + Pembrolizumab | Tumor-infiltrating lymphocyte not increased | 7 | Participants | |
| Overall Response Rate | Single Arm: Entinostat + Pembrolizumab | Complete Response or Partial Response | 3 | Participants | |
| Overall Response Rate | Single Arm: Entinostat + Pembrolizumab | Stable Disease or Progression | 8 | Participants | |
| Progression-Free Survival | Single Arm: Entinostat + Pembrolizumab | Alive with no evidence of disease | 1 | Participants | |
| Progression-Free Survival | Single Arm: Entinostat + Pembrolizumab | Alive with disease | 3 | Participants | |
| Progression-Free Survival | Single Arm: Entinostat + Pembrolizumab | Died from disease | 7 | Participants | |
| Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat Combination | Single Arm: Entinostat + Pembrolizumab | fatigue | 11 | Participants | |
| Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat Combination | Single Arm: Entinostat + Pembrolizumab | nausea | 6 | Participants | |
| Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat Combination | Single Arm: Entinostat + Pembrolizumab | vomiting | 3 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm: Entinostat + Pembrolizumab | 11 | |
| Overall Study | COMPLETED | Single Arm: Entinostat + Pembrolizumab | 11 | |
| Overall Study | NOT COMPLETED | Single Arm: Entinostat + Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events120
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 | Single Arm: Entinostat + Pembrolizumab | 8 | 11 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Single Arm: Entinostat + Pembrolizumab | 2 | 11 | |
| other | Atrial fibrillation | Cardiac disorders | Single Arm: Entinostat + Pembrolizumab | 2 | 11 | |
| other | Palpitation | Cardiac disorders | Single Arm: Entinostat + Pembrolizumab | 1 | 11 | |
| other | Sinus bradycardia | Cardiac disorders | Single Arm: Entinostat + Pembrolizumab | 2 | 11 | |
| other | Hearing impaired | Ear and labyrinth disorders | Single Arm: Entinostat + Pembrolizumab | 1 | 11 | |
| other | Adrenal insufficiency | Endocrine disorders | Single Arm: Entinostat + Pembrolizumab | 1 | 11 | |
| other | Hyperthyroidism | Endocrine disorders | Single Arm: Entinostat + Pembrolizumab | 1 | 11 | |
| other | Hypothyroidism | Endocrine disorders | Single Arm: Entinostat + Pembrolizumab | 3 | 11 | |
| other | Blurred vision | Eye disorders | Single Arm: Entinostat + Pembrolizumab | 2 | 11 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm: Entinostat + Pembrolizumab | 7 | 11 |
| Total, other adverse events | Single Arm: Entinostat + Pembrolizumab | 11 | 11 |
| Total, serious adverse events | Single Arm: Entinostat + Pembrolizumab | 5 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03765229
GET https://conductscience.org/api/trials/v1/NCT03765229/events?page=2