Adults 18 to 99, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Conversions of Non-inflamed to Inflamed MelanomaPrimary· 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).
Tumor-infiltrating lymphocyte increased
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
3
Tumor-infiltrating lymphocyte not increased
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
7
Overall Response RateSecondary· 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.
Complete Response or Partial Response
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
3
Stable Disease or Progression
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
8
Progression-Free SurvivalSecondary· 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.
Alive with no evidence of disease
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
1
Alive with disease
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
3
Died from disease
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
7
Number of Participant With Adverse Events During the Concurrent Pembrolizumab-entinostat CombinationSecondary· 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
fatigue
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
11
nausea
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
6
vomiting
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
3
diarrhea
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
7
anorexia
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
3
musculoskeletal pain
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
5
cytopenia
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
2
anemia
Group
Value
95% CI
Single Arm: Entinostat + Pembrolizumab
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 90 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Single Arm: Entinostat + Pembrolizumab
Serious: 5/11 (45%)
Deaths: 7/11
Serious adverse events (15 terms)
Reaction
System
Single Arm: Entinostat + P…
Dehydration
Metabolism and nutrition disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Anemia
Blood and lymphatic system disorders
—
Nausea
Gastrointestinal disorders
—
General disorders and administration site conditions - Other, specify
Gastrointestinal disorders
—
fatigue
General disorders
—
Hepatic pain
Hepatobiliary disorders
—
Urinary tract infection
Infections and infestations
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Tumor pain
Musculoskeletal and connective tissue disorders
—
Encephalopathy
Nervous system disorders
—
Seizure
Nervous system disorders
—
Hallucinations
Psychiatric disorders
—
Acute kidney injury
Renal and urinary disorders
—
Hematoma
Vascular disorders
—
Other adverse events (105 terms — click to expand)
Reaction
System
Single Arm: Entinostat + P…
Fatigue
General disorders
—
Lymphocyte count decreased
Investigations
—
Hypoalbuminemia
Metabolism and nutrition disorders
—
Alkaline phosphatase increased
Investigations
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Anemia
Blood and lymphatic system disorders
—
Diarrhea
Gastrointestinal disorders
—
Hyponatremia
Metabolism and nutrition disorders
—
Hypophosphatemia
Metabolism and nutrition disorders
—
Skin and subcutaneous tissue disorders - Other, specify
Skin and subcutaneous tissue disorders
—
Nausea
Gastrointestinal disorders
—
Creatinine increased
Investigations
—
Platelet count decreased
Investigations
—
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancers develop in two different ways. First, cancer cells can become invisible to the immune system by stop having proteins on their surface that are required for the immune system to recognize them. In this scenario, tumors do not attract any immune cells (e.g. white blood cells) whatsoever or they do not attract specialized white blood cells against cancer cells, called lymphocytes. White blood cells are the type of immune cells that attack foreign cells, such as cancer cells or normal cells infected with viruses or bacteria. Second, cancer cells can still grow side-to-side with white blood cells but are able to hide from them. As a result, the white blood cells cannot find and attack the cancer cells. Different types of cancers have different chance of having immune cells in the tumor. For example, the possibility that immune cells are within skin melanomas is almost 50% whereas the possibility in melanoma of the eye is only 10%.
As a result, the first goal of this study is to understand whether entinostat can make a melanoma tumor more visible to the immune system. To see whether entinostat makes tumor more visible to the immune system, participants will have a mandatory tumor biopsy 3 weeks after starting entinostat therapy. Tumor tissue collected before and after participating in this study will be compared to see if there are more immune cells in the tumor after receive entinostat. The second goal of the study is to see if giving a combination of entinostat and pembrolizumab can shrink melanoma tumors of patients who did not have immune cells in tumors prior to treatment. The study will determine how many subjects cancer has become better or not changed 6 months after subjects have started treatment on the study. We will also determine what type of side effects occur in subjects receiving entinostat and pembrolizumab to look at the safety of this combination.
The investigators will also look at any changes in the DNA of melanoma before the study begins. As a result of these changes in DNA, there are often see differences in the proteins that work to create other proteins. In addition, the study will look into how entinostat may make melanoma cells more visible to the immune system by comparing proteins in tumors before and after treatment. Finally, the study will see if this treatment changes the numbers and types of immune cells that are found in the blood by comparing blood at different time points while patients are on the study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07441486 — A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment
· Phase 2
· not yet recruiting
NCT07261592 — Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
· Phase 1, PHASE2
· not yet recruiting
NCT05898828 — Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Th
· Phase 1, PHASE2
· withdrawn
NCT05053971 — Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel,
· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 10 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03765229.