NCT03838042 is a Phase 1, PHASE2 clinical trial of Nivolumab and Entinostat in CNS Tumor, sponsored by University Hospital Heidelberg.

Who is sponsoring NCT03838042?

NCT03838042 is sponsored by University Hospital Heidelberg.

What drugs are being tested in NCT03838042?

Interventions in NCT03838042: Nivolumab and Entinostat.

What condition does NCT03838042 study?

NCT03838042 studies CNS Tumor, Solid Tumor.

Is NCT03838042 still recruiting?

NCT03838042 is currently recruiting now. Last updated 7 February 2024.

Last reviewed 2024-02-07 · How we verify

NCT03838042

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

Recruiting now Phase 1, PHASE2 Last updated 7 February 2024

What this trial tests

Phase 1, PHASE2 trial testing Nivolumab and Entinostat in CNS Tumor in 91 participants. Currently enrolling.

Timeline

26 May 2020

Primary endpoint
30 June 2026

30 June 2027

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	91
Start date	26 May 2020
Primary completion	30 June 2026
Estimated completion	30 June 2027
Sites	14 locations across France, Netherlands, Austria, Sweden, Germany, Switzerland, Australia

Drugs / interventions tested

Nivolumab and Entinostat — full drug profile →

Conditions studied

CNS Tumor — all drugs for CNS Tumor →
Solid Tumor — all drugs for Solid Tumor →

Sponsor

University Hospital Heidelberg

Who can join

Adults 2 to 21, any sex, with CNS Tumor or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
The Pediatric Precision Oncology INFORM Registry: Clinical Outcome and Benefit for Patients with Very High-Evidence Targets.
van Tilburg CM, Pfaff E, Pajtler KW, Langenberg KPS, et al · · 2021 · cited 186× · PMID 34373263 · DOI 10.1158/2159-8290.cd-21-0094
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
Immunoepigenetics Combination Therapies: An Overview of the Role of HDACs in Cancer Immunotherapy.
Banik D, Moufarrij S, Villagra A. · · 2019 · cited 96× · PMID 31067680 · DOI 10.3390/ijms20092241
Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
Implementation of paediatric precision oncology into clinical practice: The Individualized Therapies for Children with cancer program 'iTHER'.
Langenberg KPS, Meister MT, Bakhuizen JJ, Boer JM, et al · · 2022 · cited 36× · PMID 36182817 · DOI 10.1016/j.ejca.2022.09.001

Verify or expand the search:

Other recruiting trials for CNS Tumor

Currently open trials in the same condition.

NCT07236840 — Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors · recruiting
NCT05982691 — Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors · recruiting
NCT04732065 — ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors · Phase 1 · recruiting

Other University Hospital Heidelberg trials

Trials by the same sponsor.

NCT07388147 — Exercise Therapy for Multiple Myeloma Patients · NA · not yet recruiting
NCT07348874 — Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany · not yet recruiting
NCT07181928 — Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders? · NA · not yet recruiting
NCT06954623 — Partial Breast Re-irradiation for Breast Cancer · NA · recruiting
NCT06913010 — DV 100 as a Framework for the Hospital Incident Command System · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03838042 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Heidelberg
Last refreshed: 7 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03838042.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing