Evidence map›Paper›PMID 41962308›Full record

Trial reportESMO open2026

Efficacy and safety of regorafenib in patients with advanced pretreated melanoma: results of the RegoMel phase II clinical trial.

I Dirven, C Bertels, Y Moreels, J I Kessels, N Vanlaer, A-S Vander Mijnsbrugge, M Vounckx, I Dirks, L Raes, X Geeraerts and 12 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05370807 (A Phase-2 Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma - Definition of Two Additional Stratified Patient Cohorts of Regorafenib Plus BRAF-/MEK-inhibitors in Pretreated BRAF V600-mutant Melanoma Patients), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05370807 phase2unknown statusnot on this map

A Phase-2 Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma - Definition of Two Additional Stratified Patient Cohorts of Regorafenib Plus BRAF-/MEK-inhibitors in Pretreated BRAF V600-mutant Melanoma Patients

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2022 to 2025Enrolled48ConditionsMelanoma Stage III, Melanoma Stage IVArmsRegorafenib 40 MG Oral Tablet, Triplet therapy
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

I DirvenDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium. Electronic address: iris.dirven@uzbrussel.be.
C BertelsDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
Y MoreelsDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
J I KesselsDepartment of Dermatology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
N VanlaerDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
A-S Vander MijnsbruggeDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
M VounckxDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
I DirksDepartment of Electronics and Informatics (ETRO), Vrije Universiteit Brussel (VUB), Brussels, Belgium; Imec, Leuven, Belgium.
L RaesDepartment of Nuclear Medicine, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
X GeeraertsTeam Laboratory for Medical and Molecular Oncology (LMMO), Translational Oncology Research Center (TORC), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
L StevensTeam Laboratory for Medical and Molecular Oncology (LMMO), Translational Oncology Research Center (TORC), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
B von KempDepartment of Cardiology (Centrum Hart- en Vaatziekten, CHVZ), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
G FasolinoDepartment of Ophthalmology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
G AwadaDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.
T JanssenBrussels Interuniversity Genomics High Throughput core (Brightcore), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
B CaljonBrussels Interuniversity Genomics High Throughput core (Brightcore), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
T LefevreBrussels Interuniversity Genomics High Throughput core (Brightcore), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
H EveraertDepartment of Nuclear Medicine, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
A RogiersDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium; Department of Psychiatry, CHU Brugman, Brussels, Belgium.
J VandemeulebrouckeTeam Laboratory for Medical and Molecular Oncology (LMMO), Translational Oncology Research Center (TORC), Vrije Universiteit Brussel (VUB), Brussels, Belgium; Department of Cardiology (Centrum Hart- en Vaatziekten, CHVZ), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium; Department of Radiology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
S TuyaertsTeam Laboratory for Medical and Molecular Oncology (LMMO), Translational Oncology Research Center (TORC), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
B NeynsDepartment of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Translational Oncology Research Center (TORC), Team Laboratory for Medical and Molecular Oncology (LMMO), Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost patients with advanced melanoma progress despite standard-of-care treatments. Regorafenib (REGO), an oral multikinase inhibitor with RAF-dimer activity, demonstrated clinical activity in melanoma in retrospective case series and preclinical efficacy in overcoming resistance to BRAF/MEK inhibitors (BRAF/MEKi). This study prospectively evaluated REGO in heavily pretreated advanced melanoma patients. PATIENTS AND

methodsThis single-center, phase II clinical trial (RegoMel, NCT05370807) assessed the objective response rate (ORR) upon continuous REGO dosing (40-120 mg daily) in 16 patients with advanced pretreated melanoma, regardless of the melanoma driver mutation. In BRAF

resultsThere was one complete (BRAF

conclusionThis phase II clinical trial met its primary endpoint, demonstrating clinically meaningful antitumor activity and manageable toxicity with continuous daily REGO in advanced pretreated melanoma. The unprecedented high response rates in KIT-mutant melanoma and encouraging activity in BRAF

Indexed as

Antineoplastic AgentsMelanomaPhenylurea CompoundsPyridinesAdultAgedFemaleHumansMaleMiddle AgedMutationProgression-Free SurvivalProspective StudiesProto-Oncogene Proteins B-rafProto-Oncogene Proteins c-kitAntineoplastic AgentsBRAF protein, humanPhenylurea CompoundsProto-Oncogene Proteins B-rafProto-Oncogene Proteins c-kitPyridinesregorafenibBRAF/MEK inhibitorsKIT-mutationmelanomaprospective clinical trialRAF dimer inhibitorregorafenib

Identifiers

PMID41962308
PMCPMC13091192

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.