Trial · NCT03838042
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
NCT03838042, Phase 1, Phase 2, Recruiting, University Hospital Heidelberg
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies. Trials, record NCT03838042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03838042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
- NCT number
- NCT03838042
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 91 participants, estimated
- Lead sponsor
- University Hospital Heidelberg
- Conditions
- CNS Tumor, Solid Tumor
- Interventions
- Nivolumab and Entinostat
- First posted
- 2019-02-12
- Last updated
- 2024-02-07
- Other registries' IDs
- eudract:2018-000127-14
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32503469 | DERIVED |
Source PubMed
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03838042
GET https://conductscience.org/api/trials/v1/NCT03838042/registered?page=2