NCT03944356 (Combi-EU) is a clinical trial of Dabrafenib and Trametinib in Melanoma, sponsored by EuMelaReg gGmbH.

Who is sponsoring NCT03944356?

NCT03944356 is sponsored by EuMelaReg gGmbH.

What drugs are being tested in NCT03944356?

Interventions in NCT03944356: Dabrafenib and Trametinib.

Is NCT03944356 still recruiting?

NCT03944356 is currently completed. Last updated 12 March 2025.

Last reviewed 2025-03-12 · How we verify

NCT03944356: Combi-EU

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

BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

Completed Last updated 12 March 2025

What this trial tests

trial testing Dabrafenib and Trametinib in Melanoma in 232 participants. Completed in 8 October 2024.

Timeline

1 July 2019

Primary endpoint
31 December 2023

8 October 2024

Quick facts

Lead sponsor	EuMelaReg gGmbH
Status	Completed
Study type	OBSERVATIONAL
Enrollment	232
Start date	1 July 2019
Primary completion	31 December 2023
Estimated completion	8 October 2024
Sites	36 locations across Germany

Drugs / interventions tested

Dabrafenib and Trametinib — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

EuMelaReg gGmbH

Who can join

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

Sponsor's own description

Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency). The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

Publications & conference data

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

The future of targeted kinase inhibitors in melanoma.
Caksa S, Baqai U, Aplin AE. · · 2022 · cited 25× · PMID 35513054 · DOI 10.1016/j.pharmthera.2022.108200
COMBI-EU: Real-World Evidence on Adverse Event Management and Time on Therapy with Adjuvant Dabrafenib Plus Trametinib in Patients with BRAF V600-Mutant Melanoma.
Weichenthal M, Debus D, Zimmer L, Wasielewski IV, et al · · 2026 · PMID 41749920 · DOI 10.3390/cancers18040667
COMBI-EU: Real-World Evidence on Adverse Event Management and Time on Therapy with Adjuvant Dabrafenib Plus Trametinib in Patients with BRAF V600-Mutant Melanoma
Weichenthal M, Debus D, Zimmer L, von Wasielewski I, et al · · 2026

Verify or expand the search:

Other trials of Dabrafenib and Trametinib

Trials testing the same drug.

NCT04489433 — Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melano · no longer available
NCT04544202 — Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection · no longer available

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · 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 NCT03944356 (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 EuMelaReg gGmbH
Last refreshed: 12 March 2025

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/NCT03944356.

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