Trial · NCT02437136
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
NCT02437136, Phase 1, Phase 2, Completed, Syndax Pharmaceuticals; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC). Trials, record NCT02437136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02437136
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
- NCT number
- NCT02437136
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 191 participants, actual
- Lead sponsor
- Syndax Pharmaceuticals
- Conditions
- Non-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal Cancer
- Interventions
- entinostat, pembrolizumab
- First posted
- 2015-05-07
- Last updated
- 2025-03-20
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | From date of randomization to date of progression (up to 765 days) | The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.4375 days. |
| Secondary | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | 6 months | The CBR was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) lasting for at least 6 months. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. SD: Sum of the diameters (longest for nonnodal lesions, shortest for nodal lesions) of target and new measurable lesions neither CR, PR, (compared to baseline) or progressive disease (PD) (compared to nadir). |
| Secondary | Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 6 months | The CBR was defined as the percentage of participants with a confirmed CR, PR, or SD lasting for at least 6 months. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Phase 2: Progression Free Survival (PFS), as Assessed Using irRECIST | 6 months | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. Number of participants without evidence of progression or death at Month 6 are reported. |
| Secondary | Phase 2: PFS, as Assessed Using RECIST 1.1 | 6 months | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. Number of participants without evidence of progression or death at Month 6 are reported. |
| Secondary | Phase 2: PFS Duration, as Determined by the Local Investigator Using irRECIST | From date of randomization to PD or death due to any cause (up to 765 days) | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. |
| Secondary | Phase 2: PFS Duration, as Determined by the Local Investigator Using RECIST 1.1 | From date of randomization to PD or death due to any cause (up to 765 days) | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. |
| Secondary | Phase 2: Overall Survival | From date of randomization to the date of death (up to 765 days) | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). For purposes of analysis, 1 month was considered to be 30.4375 days. |
| Secondary | Phase 2: Duration of Response, as Assessed Using irRECIST | From start date of CR or PR to date of progression (up to 765 days) | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. |
| Secondary | Phase 2: Duration of Response, as Assessed Using RECIST 1.1 | From start date of CR or PR to date of progression (up to 765 days) | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | From date of randomization to date of progression (up to 765 days) | Full analysis set (FAS) included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | 6 months | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 6 months | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Progression Free Survival (PFS), as Assessed Using irRECIST | 6 months | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: PFS, as Assessed Using RECIST 1.1 | 6 months | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: PFS Duration, as Determined by the Local Investigator Using irRECIST | From date of randomization to PD or death due to any cause (up to 765 days) | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | months | MEDIAN |
| SECONDARY | Phase 2: PFS Duration, as Determined by the Local Investigator Using RECIST 1.1 | From date of randomization to PD or death due to any cause (up to 765 days) | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | months | MEDIAN |
| SECONDARY | Phase 2: Overall Survival | From date of randomization to the date of death (up to 765 days) | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response, as Assessed Using irRECIST | From start date of CR or PR to date of progression (up to 765 days) | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response, as Assessed Using RECIST 1.1 | From start date of CR or PR to date of progression (up to 765 days) | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 22.2 | 95% Confidence Interval 6.4 to 47.6 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 9.2 | 95% Confidence Interval 3.8 to 18.1 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | 18.9 | 95% Confidence Interval 9.4 to 32.0 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | 5.4 | 95% Confidence Interval 0.7 to 18.2 | percentage of participants | |
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 33.3 | 95% Confidence Interval 13.3 to 59.0 | percentage of participants | |
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 14.5 | 95% Confidence Interval 7.5 to 24.4 | percentage of participants | |
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | 35.8 | 95% Confidence Interval 23.1 to 50.2 | percentage of participants | |
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | 8.1 | 95% Confidence Interval 1.7 to 21.9 | percentage of participants | |
| Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 22.2 | 95% Confidence Interval 6.4 to 47.6 | percentage of participants | |
| Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 14.5 | 95% Confidence Interval 7.5 to 24.4 | percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 6 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 7 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 9 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 0 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 0 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | 0 | |
| Dose Escalation/Confirmation (Phase 1b) | STARTED | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | 0 | |
| Dose Escalation/Confirmation (Phase 1b) | Received at Least 1 Dose of Study Drug | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 6 | |
| Dose Escalation/Confirmation (Phase 1b) | Received at Least 1 Dose of Study Drug | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 7 | |
| Dose Escalation/Confirmation (Phase 1b) | Received at Least 1 Dose of Study Drug | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 9 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events3,395
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 | Fatigue | General disorders | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 2 | 6 | |
| other | Fatigue | General disorders | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 6 | 7 | |
| other | Fatigue | General disorders | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 6 | 9 | |
| other | Fatigue | General disorders | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 14 | 18 | |
| other | Fatigue | General disorders | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 36 | 76 | |
| other | Fatigue | General disorders | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | 29 | 53 | |
| other | Fatigue | General disorders | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | 22 | 38 | |
| other | Oedema peripheral | General disorders | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 1 | 6 | |
| other | Oedema peripheral | General disorders | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 1 | 7 | |
| other | Oedema peripheral | General disorders | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 0 | 9 |
1 to 10 of 3,395Source ClinicalTrials.gov
See all 3,395 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 6 | 6 |
| Total, all-cause mortality | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 0 | 7 |
| Total, all-cause mortality | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 1 | 9 |
| Total, all-cause mortality | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | 8 | 18 |
| Total, all-cause mortality | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | 41 | 76 |
| Total, all-cause mortality | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | 31 | 53 |
| Total, all-cause mortality | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | 25 | 38 |
| Total, other adverse events | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | 6 | 6 |
| Total, other adverse events | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | 7 | 7 |
| Total, other adverse events | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | 9 | 9 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT02437136/results?page=2