Trial · NCT02453620
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events of entinostat and nivolumab in combination with ipilimumab | Up to 100 days after last dose of nivolumab | Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Safety and tolerability will be analyzed through the incidence of adverse events, serious adverse events, and specific laboratory abnormalities (worst grade) in each arm. Toxicities will be tabulated by type and grade for all doses and presented using frequencies and percentages based on the CTCAE v5.0. The proportion of dose-limiting toxicities at each dose level will be reported with exact 95% confidence intervals. |
| Secondary | Changes in ratio of effector T cell (Teff) to regulatory T cell (Treg) in tumor biopsies | Baseline to up to 2 weeks post-entinostat | Measured by immunohistochemistry (IHC) staining of paraffin embedded tumor specimens. Changes will be treated as a continuous variable and summarized with descriptive statistics. Changes will also be graphically depicted using exploratory plots (e.g. bar plots, boxplots) and means will be estimated with 95% confidence intervals. A paired t-tests or nonparametric Wilcoxon signed-rank test may be used to determine whether or not the data shows evidence of changes from baseline. |
| Secondary | Objective response rate | Up to 5 years | Defined as the total number of patients with either complete response (CR) or partial response (PR) divided by the total number of patients in the population of interest (expansion cohort of patients with advanced breast cancer). Tumor assessment will be based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and immune related response criteria (irRC). |
| Secondary | Disease control rate (expansion cohort of patients with advanced breast cancer) | Up to 5 years | Defined as the percentage of patients who have achieved CR, PR or stable disease (SD) among all response evaluable patients based on RECIST v1.1 and irRC. Estimated by the number of patients who achieve a confirmed response plus the number of patients who have stable disease for a duration of at least 6 months divided by the total number of evaluable patients. |
| Secondary | Progression-free survival (PFS) | Time from start of treatment to time of disease progression or death, whichever occurs first, assessed at 6 months | Defined as the proportion of patients remaining alive and free of disease progression (expansion cohort of patients with advanced breast cancer). Exact binomial 95% confidence intervals will be provided. The distribution of PFS, duration of response, and duration of stable disease will be described using the method of Kaplan-Meier, if warranted. Advanced breast cancer patients in the dose escalation portion treated at the recommended phase 2 dose (RP2D), if any, will be pooled with patients in the dose expansion cohort for these analyses. |
| Secondary | Duration of overall response (expansion cohort of patients with advanced breast cancer) | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed up to 5 years | Duration of response will be described using the method of Kaplan-Meier, if warranted. Advanced breast cancer patients in the dose escalation portion treated at the RP2D, if any, will be pooled with patients in the dose expansion cohort for these analyses. |
| Secondary | Duration of stable disease (expansion cohort of patients with advanced breast cancer) | Time measurement criteria are met for SD until the first date that recurrent or progressive disease is objectively documented or death, assessed up to 5 years | Based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and immune related response criteria (irRC). Duration of stable disease will be described using the method of Kaplan-Meier, if warranted. Advanced breast cancer patients in the dose escalation portion treated at the RP2D, if any, will be pooled with patients in the dose expansion cohort for these analyses. |
| Other | Changes in number of myeloid derived suppressor cells (MDSCs) in peripheral blood and tumor biopsies | Baseline to up to 8 weeks | Measured by flow cytometry pre and post-therapy. Summarized with descriptive statistics and graphically displayed by exploratory plots for overall and by tumor type if warranted. Changes will be estimated as a ratio change (post/pre) and data will be log transformed as appropriate. Difference between pre- and post-therapy will be explored using paired t-tests or Wilcoxon signed rank tests as appropriate for continuous variables and McNemar's test for dichotomous or categorical variables. Distributions of immune parameters across clinical responders and non-responders will be evaluated and graphically displayed using box plots. |
| Other | Post-combination therapy expression of checkpoint inhibitors (PD-1/PD-L1) in tumor biopsies | Up to 8 weeks | Measured by immunohistochemistry (IHC). Summarized with descriptive statistics and graphically displayed by exploratory plots for overall and by tumor type if warranted. Changes will be estimated as a ratio change (post/pre) and data will be log transformed as appropriate. Difference between pre- and post-therapy will be explored using paired t-tests or Wilcoxon signed rank tests as appropriate for continuous variables and McNemar's test for dichotomous or categorical variables. Distributions of immune parameters across clinical responders and non-responders will be evaluated and graphically displayed using box plots. |
| Other | Changes in other immune-related biomarkers (e.g., ratio of effector T cells: regulatory T cells, inflammatory T cell signature, T cell receptor [TCR] repertoire) in tumor biopsies or peripheral blood lymphocytes (PBL) pre and post therapy | Baseline to up to 8 weeks | Summarized with descriptive statistics and graphically displayed by exploratory plots for overall and by tumor type if warranted. Changes will be estimated as a ratio change (post/pre) and data will be log transformed as appropriate. Difference between pre- and post-therapy will be explored using paired t-tests or Wilcoxon signed rank tests as appropriate for continuous variables and McNemar's test for dichotomous or categorical variables. Distributions of immune parameters across clinical responders and non-responders will be evaluated and graphically displayed using box plots. |
| Other | Tumor-specific mutations and mutant neo-antigens recognized by patient T cells in tumor biopsies | Up to 8 weeks | Measured by whole-exome sequencing. |
| Other | Changes in frequency of T cells recognizing tumor-specific mutant neo-antigens in tumor biopsies pre and post-therapy | Baseline to up to 8 weeks | |
| Other | Changes in candidate gene re-expression in malignant tissue, gene methylation silencing in circulating deoxyribonucleic acid (DNA) and malignant tissue pre and post-therapy | Baseline to up to 8 weeks | Changes will be estimated as a ratio change (post/pre) and data will be log transformed as appropriate to induce symmetry and stabilize the variability. Difference between pre- and post-therapy will be explored using paired t-tests or Wilcoxon signed rank tests as appropriate for continuous variables and McNemar's test for dichotomous or categorical variables. Distributions of immune parameters across clinical responders and non-responders will be evaluated and graphically displayed using box plots. Change in these parameters with tumor response evaluated using Jonckheere-Terpstra trend test, Wilcoxon rank sum test as well as logistic regression where appropriate. |
| Other | Pharmacodynamic outcomes (e.g., safety, efficacy, and changes in gene methylation status) with the exposure of entinostat when coadministered with nivolumab with or without ipilimumab | Up to 5 years | Association of baseline and change in these parameters with clinical response will be evaluated using Wilcoxon rank sum tests. |
| Other | CD86 gene polymorphisms as genetic determinants of immune mediated adverse events | Up to 8 weeks | Pharmacogenomic association analyses will be performed using Fisher's exact test or Cochran-Armitage trend test to explore the potential clinical utility of CD86 gene polymorphisms as genetic determinants of immune mediated adverse events. Methods such as logistic or proportional hazards regression will likely be used for these analyses as appropriate. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02453620/registered