NCT03903458 (ENIgMA) is a Phase 1 clinical trial of Tinostamustine in Malignant Melanoma, sponsored by Markus Joerger.

Who is sponsoring NCT03903458?

NCT03903458 is sponsored by Markus Joerger.

What drugs are being tested in NCT03903458?

Interventions in NCT03903458: Tinostamustine.

What condition does NCT03903458 study?

NCT03903458 studies Malignant Melanoma.

Is NCT03903458 still recruiting?

NCT03903458 is currently status unknown. Last updated 8 April 2019.

Last reviewed 2019-04-08 · How we verify

NCT03903458: ENIgMA

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

Tinostamustine and Nivolumab in Advanced Melanoma

Status unknown Phase 1 Last updated 8 April 2019

What this trial tests

Phase 1 trial testing Tinostamustine in Malignant Melanoma in 21 participants. Status unknown.

Timeline

7 March 2019

Primary endpoint
15 December 2021

15 March 2024

Quick facts

Lead sponsor	Markus Joerger
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	7 March 2019
Primary completion	15 December 2021
Estimated completion	15 March 2024
Sites	2 locations across Switzerland

Drugs / interventions tested

Tinostamustine — full drug profile →

Conditions studied

Malignant Melanoma — all drugs for Malignant Melanoma →

Sponsor

Markus Joerger

Who can join

18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a first-in-human drug combination with the first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule Tinostamustine (EDO-S101) and the anti-PD-1 monoclonal antibody Nivolumab in patients with refractory, locally advanced or metastatic melanoma.

Publications & conference data

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

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
Signal pathways of melanoma and targeted therapy.
Guo W, Wang H, Li C. · · 2021 · cited 251× · PMID 34924562 · DOI 10.1038/s41392-021-00827-6
Study and analysis of antitumor resistance mechanism of PD1/PD-L1 immune checkpoint blocker.
Wang Z, Wu X. · · 2020 · cited 147× · PMID 32875727 · DOI 10.1002/cam4.3410
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
Targeting histone deacetylases for cancer therapy: Trends and challenges.
Liang T, Wang F, Elhassan RM, Cheng Y, et al · · 2023 · cited 128× · PMID 37425042 · DOI 10.1016/j.apsb.2023.02.007
Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
Novel Approaches to Epigenetic Therapies: From Drug Combinations to Epigenetic Editing.
Majchrzak-Celińska A, Warych A, Szoszkiewicz M. · · 2021 · cited 85× · PMID 33572577 · DOI 10.3390/genes12020208
Epigenetic modifications in diabetes.
Kowluru RA, Mohammad G. · · 2022 · cited 46× · PMID 34715117 · DOI 10.1016/j.metabol.2021.154920

Verify or expand the search:

Other trials of Tinostamustine

Trials testing the same drug.

NCT05432375 — Study of Tinostamustine for Adjuvant Treatment of Glioblastoma · EARLY_PHASE1 · completed
NCT03687125 — Tinostamustine Conditioning and Autologous Stem Cell · Phase 1, PHASE2 · terminated
NCT03452930 — Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastom · Phase 1 · completed
NCT02576496 — Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancie · Phase 1 · completed

Other recruiting trials for Malignant Melanoma

Currently open trials in the same condition.

NCT07371663 — An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT06961006 — A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-0 · Phase 2 · recruiting
NCT06974734 — A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies · Phase 1 · active not recruiting
NCT06980740 — Video-Tumorboard PLUS · recruiting
NCT06560905 — Preoperative Planning With PSMA-PET in Melanoma Surgery Trial · Phase 2 · 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 NCT03903458 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Markus Joerger
Last refreshed: 8 April 2019

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/NCT03903458.

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