Trial · NCT02437136
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Phase 2: Time to Response, as Assessed Using irRECIST | From the date of randomization to date of PR or CR (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: Time to Response, as Assessed Using RECIST 1.1 | From the date of randomization to date of PR or CR (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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | From first dose of study drug up to 765 days | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b: Number of Participants With at Least One Dose Limiting Toxicities (DLTs) | Day 1 through Day 21 (Cycle 1) | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b: Recommended Phase 2 Dose (RP2D) | Day 1 through Day 21 (Cycle 1) | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | mg | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02437136/outcomes