Evidence map›Paper›PMID 28592387›Full record

Trial reportThe Lancet. Oncology2017

Dabrafenib plus trametinib in patients with BRAF

Michael A Davies, Philippe Saiag, Caroline Robert, Jean-Jacques Grob, Keith T Flaherty, Ana Arance, Vanna Chiarion-Sileni, Luc Thomas, Thierry Lesimple, Laurent Mortier and 10 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Lancet. Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 375 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
375citing papers in PubMed, 10 pooled it
–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.

NCT05501912 phase1terminatednot on this mapstarted 2022, after this paper: background citation

A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Cancer Activity of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

TypeinterventionalSponsorABM Therapeutics Shanghai Company LimitedRan2022 to 2024Enrolled20ConditionsAdvanced Solid Tumor, BRAF V600 MutationArmsABM-1310
NCT06887088 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Phase II, Single Arm, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib Plus Binimetinib Followed by Cemiplimab And Fianlimab in Patients With BRAF Mutated Melanoma and Symptomatic Brain Metastases

TypeinterventionalSponsorGrupo Español Multidisciplinar de MelanomaRan2025 to 2028Enrolled33ConditionsMelanoma BRAF V600E/K Mutated, Melanoma and Brain MetastasesArmsEncorafenib + Binimetinib, cemiplimab+fianlimab
3 · Its place in the literature

Who cites it

375 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  4. Guideline
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. SEOM-GEINO clinical guideline of systemic therapy and management of brain central nervous system metastases (2021).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Guideline
  9. Pooled it
  10. Pooled it
  11. Trial
  12. Trial
  13. Trial
  14. Response Rate and Molecular Correlates to Encorafenib and Binimetinib in BRAF-V600E Mutant High-Grade Glioma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Article
  20. Brain metastasis: Opportunities for novel therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review

315 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Michael A DaviesMelanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mdavies@mdanderson.org.
Philippe SaiagService de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt, France.
Caroline RobertGustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.
Jean-Jacques GrobService de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille, France.
Keith T FlahertyDevelopmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.
Ana AranceDepartment of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona, Spain.
Vanna Chiarion-SileniMelanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.
Luc ThomasService de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.
Thierry LesimpleOncologie Dermatologique, Centre Eugène Marquis, Rennes, France.
Laurent MortierClinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille, France.
Stergios J MoschosMelanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
David HoggClinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Iván Márquez-RodasServicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid, Spain.
Michele Del VecchioFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Céleste LebbéAPHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris, France.
Nicolas MeyerMedical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
Ying ZhangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Yingjie HuangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Bijoyesh MookerjeeNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Georgina V LongMelanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.

Funding

TRAINING FOR ACADEMIC ONCOLOGY/HEMATOLOGYT32CA009666 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Michael Davies, Courtney DiNardo · 1994 to 2026
$9.8M
The Role of the PI3K-AKT Pathway in Melanoma Brain MetastasisR01CA154710 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DAVIES, MICHAEL · 2011 to 2015
$1.6M
NCI NIH HHS R01 CA154710NCI NIH HHS T32 CA009666
6 · The paper itself

Abstract

backgroundDabrafenib plus trametinib improves clinical outcomes in BRAF

methodsThis ongoing, multicentre, multicohort, open-label, phase 2 study evaluated oral dabrafenib (150 mg twice per day) plus oral trametinib (2 mg once per day) in four patient cohorts with melanoma brain metastases enrolled from 32 hospitals and institutions in Europe, North America, and Australia: (A) BRAF

findingsBetween Feb 28, 2014, and Aug 5, 2016, 125 patients were enrolled in the study: 76 patients in cohort A; 16 patients in cohort B; 16 patients in cohort C; and 17 patients in cohort D. At the data cutoff (Nov 28, 2016) after a median follow-up of 8·5 months (IQR 5·5-14·0), 44 (58%; 95% CI 46-69) of 76 patients in cohort A achieved an intracranial response. Intracranial response by investigator assessment was also achieved in nine (56%; 95% CI 30-80) of 16 patients in cohort B, seven (44%; 20-70) of 16 patients in cohort C, and ten (59%; 33-82) of 17 patients in cohort D. The most common serious adverse events related to study treatment were pyrexia for dabrafenib (eight [6%] of 125 patients) and decreased ejection fraction (five [4%]) for trametinib. The most common grade 3 or worse adverse events, regardless of study drug relationship, were pyrexia (four [3%] of 125) and headache (three [2%]).

interpretationDabrafenib plus trametinib was active with a manageable safety profile in this melanoma population that was consistent with previous dabrafenib plus trametinib studies in patients with BRAF

fundingNovartis.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsFemaleFeverHeadacheHumansImidazolesMagnetic Resonance ImagingMaleMelanomaMiddle AgedMutationOximesBRAF protein, humandabrafenibImidazolesOximesProto-Oncogene Proteins B-rafPyridonesPyrimidinonestrametinib

Identifiers

PMID28592387
PMCPMC5991615

What OpenQuestion holds

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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.