Trial · NCT03838042
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Dose Limiting Toxicity (DLT) of the combination treatment. | 5 weeks | A dose limiting toxicity (DLT) is defined as any AE according to the definitions and exceptions listed below that is related to the administration of the combination of investigational agents occurring during the priming week and first cycle of combination treatment (first 5 weeks) in phase I of the trial. A study participant will be considered evaluable for a DLT if at least 2 doses of nivolumab and 4 doses of entinostat were administered during the first 5 weeks (5 weeks normally incorporate the priming week and 1 cycle of planned combination treatment). Participants who discontinue treatment or have treatment delays preventing them from receiving the above defined minimal amount of treatment in the first cycle of combination treatment for reasons unrelated to study drug toxicity, are not evaluable for DLT and will be replaced in enrollment (maximum number of replacement subjects will be 3 per dose level). |
| Primary | Phase II: Best response (CR or PR) | Change in 24 weeks | Best response (CR or PR) will be based on RANO criteria for all primary CNS tumors and RECIST for non-CNS tumors, defined for each patient as the best response under study combination therapy during the first 6 cycles (assessment every 2 cycles). Calcified or intra-osseous (osteo)sarcoma target lesions which were progressive before initiation of treatment and show SD on response evaluation (confirmation through a subsequent scan at least 4 weeks later) will be considered as a responder. |
| Secondary | Duration of Response (DOR) | Phase II: maximum of 48 weeks | DOR will be evaluated for all patients who experienced (confirmed) response. Starting time point will be the time when best response was determined. |
| Secondary | Disease Control Rate (DCR) | Phase II: maximum of 48 weeks | DCR will be evaluated in addition, also using iRECIST and iRANO. |
| Secondary | Stable disease (SD) | Phase II: maximum of 12 cycles (each cycle is 28 days) | SD will be evaluated in addition, also using iRECIST and iRANO. |
| Secondary | Progression-free survival (PFS) | 4 years | The event-time endpoint PFS will be estimated using the Kaplan-Meier method, considering all the patients who started the treatment, whatever their compliance to treatment, including if the treatment was stopped prematurely for a reason other than disease progression. 95%-Confidence intervals will be provided for the Kaplan-Meier estimates. |
| Secondary | Time to Response (TTR) | Phase II: maximum of 12 cycles (each cycle is 28 days) | The event-time endpoint TTR will be estimated using the Kaplan-Meier method, considering all the patients who started the treatment, whatever their compliance to treatment, including if the treatment was stopped prematurely for a reason other than disease progression. 95%-Confidence intervals will be provided for the Kaplan-Meier estimates. |
| Secondary | Overall Survival (OS) | Phase II: maximum of 48 weeks | The event-time endpoint OS will be estimated using the Kaplan-Meier method, considering all the patients who started the treatment, whatever their compliance to treatment, including if the treatment was stopped prematurely for a reason other than disease progression. 95%-Confidence intervals will be provided for the Kaplan-Meier estimates. |
| Secondary | Immune related Response Rate (RR) measured by iRECIST criteria and iRANO criteria | Phase II: maximum of 48 weeks | As a secondary endpoint for patients who continued treatment beyond progression in case of clinical benefit, response as assessed by iRECIST or iRANO will be performed. |
| Secondary | Maximum Plasma Time (Tmax) | one week | Time to reach the maximum concentration (hr). |
| Secondary | Maximum Plasma Concentration (Cmax) | one week | The peak plasma concentration of a drug after Administration (ng/mL) |
| Secondary | Half-life | one week | The time required for the concentration of the drug to reach half of its original value (hr) |
| Secondary | Area under the curve (AUC) | one week | The integral of the concentration-time curve (ng/mL·hr) |
| Secondary | total Clearance (CI/F) | one week | The total body clearance will be equal to the renal clearance + hepatic clearance + lung clearance (L/h/m²) |
| Other | Exploratory: circulating tumor DNA (ctDNA) | At baseline and every odd cycle (Cycle 3 - 12) and every third cycle (Cycle 13 - 24) (each cycle is 28 days). | Assessment of circulating Tumor DNA in peripheral blood. |
| Other | Exploratory: Response prediction | 4 years | Response prediction in a co-clinical PDX model and drug testing program |
| Other | Exploratory: Immune phenotyping (FACS Panel) and Luminex cytokine panel | At baseline, after the priming week and after 5 weeks of initiation of therapy | Immune phenotyping (FACS Panel) and Luminex cytokine panel in peripheral blood. |
| Other | Exploratory: mRNA expression | 4 years | Analyze mRNA Expression data for Tumor infiltrating immune cell populations |
| Other | Exploratory: gene signatures | 4 years | Analyze gene signature in whole exome data |
| Other | Exploratory: cryptic transcription start sites | At baseline, after priming week and after 5 weeks of initiation of therapy | Test induction of cryptic transcription start sites |
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/NCT03838042/registered