marked.bio

BRAF inhibitor · small molecule

dabrafenib

33 active trials across 9 of our biomarkers, targeting BRAF V600. 13 active approvals for a biomarker on marked.bio.

Also known as GSK2118436, Tafinlar.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
dabrafenib with trametinib
FDA, 2017
metastatic, BRAF V600E Label 1.4. Year confirmed: FDA approval announced 22/06/2017. Source
EU (EMA), 2017
advanced, BRAF V600 mutation EU label says 'BRAF V600 mutation' (broader than the FDA's V600E). WS/0996, EC decision 29/03/2017. Source
Tafinlartrametinib page 		BRAF V600E NSCLC Approved 2017 Approved 2017

In the US approval report

BRF113928 single-arm, 36 untreated; 57 previously treated
Response 61% (untreated); 63% (previously treated)Lasting not reached (untreated); 12.6 months (previously treated)

Stopped for side effects 18%

Trial details and side effects
Patients
BRAF V600E NSCLC (NCT01336634)
Most common side effects
pyrexia 55%, fatigue 51%, nausea 45%, vomiting 33%, diarrhoea 32%, dry skin 31% (93 patients)
Notes
Dabrafenib with trametinib. Side effects from the Tafinlar US label rev. 03/2025.
Source
US approval report

In the EU product information

BRF113928 single-arm, 36 untreated; 57 previously treated
Response 64% (untreated); 68% (previously treated) (46-79; 55-80)Lasting 10.2 months (untreated); 9.8 months (previously treated)

Trial details and side effects
Patients
BRAF V600E NSCLC (NCT01336634)
Most common side effects
pyrexia 55%, fatigue 51%, nausea 45%, vomiting 33%, diarrhoea 32%, dry skin 31% (93 patients)
Notes
EU SmPC section 5.1 (BRF113928 cohorts C and B). Side effects from the US label.
Source
EU product information
dabrafenib with trametinib
FDA, 2018
locally advanced or metastatic, BRAF V600E, no satisfactory locoregional options FDA approval 04/05/2018 (regular); current label 1.5. No EU equivalent. Source
Tafinlartrametinib page 		BRAF V600E anaplastic thyroid cancer Approved 2018 Not approved

BRF117019 (ROAR, ATC cohort) single-arm, 23 patients
Response 61% (39-80)Lasting 64% of responses lasted 6 months or more

Trial details and side effects
Patients
BRAF V600E anaplastic thyroid cancer (NCT02034110)
Notes
Dabrafenib with trametinib. From the FDA approval report (2018).
Source
US approval report
dabrafenib with trametinib
EU (EMA), 2026
locally advanced or metastatic, BRAF V600E, refractory to or not eligible for radioactive iodine, progressed during/after prior systemic therapy Worksharing EMA/VR/0000278305 (Tafinlar + Mekinist): CHMP opinion 26/03/2026, EC decision 30/04/2026. No FDA DTC indication. Source
Tafinlartrametinib page 		BRAF V600E differentiated thyroid cancer Not approved Approved 2026

J12301 vs placebo, 101 vs 52 patients
PFS 12.8 months vs 3.7 months, HR 0.38 (0.25-0.57)Response 57% vs 4%OS HR 0.66 (0.36-1.19), not significant

Trial details and side effects
Patients
BRAF V600E differentiated thyroid cancer, refractory to or unsuitable for radioactive iodine
Notes
Dabrafenib with trametinib. EU SmPC section 5.1. Side effects not yet in our data.
Source
EU product information
dabrafenib
FDA, 2013
unresectable or metastatic, BRAF V600E (monotherapy) Label 1.1 single agent, BRAF V600E. Year confirmed: FDA approval announced 29/05/2013. Source
EU (EMA), 2013
unresectable or metastatic, BRAF V600 mutation MA 26/08/2013. EU label now covers adults and adolescents >=12 years. Source
Tafinlar 		BRAF V600E melanoma Approved 2013 Approved 2013

In the US approval report

BREAK-3 vs dacarbazine, 187 vs 63 patients
PFS 5.1 months vs 2.7 months, HR 0.33Response 52% vs 17%OS HR no significant difference

Trial details and side effects
Patients
first-line BRAF V600E melanoma (NCT01227889)
Most common side effects
hyperkeratosis 37%, headache 32%, pyrexia 28%, arthralgia 27%, papilloma 27%, alopecia 22%
Notes
From the FDA approval report (2013).
Source
US approval report

In the EU product information

BREAK-3 vs dacarbazine, 187 vs 63 patients
PFS 6.9 months vs 2.7 months, HR 0.37 (0.24-0.58)Response 59% vs 24%OS HR 0.76 (0.48-1.21)

Trial details and side effects
Patients
first-line BRAF V600E melanoma (NCT01227889)
Most common side effects
hyperkeratosis 37%, headache 32%, pyrexia 28%, arthralgia 27%, papilloma 27%, alopecia 22%
Notes
EU SmPC section 5.1 (BREAK-3, June 2012 cut). Side effects from the US label.
Source
EU product information
dabrafenib with trametinib
FDA, 2014
unresectable or metastatic, BRAF V600E or V600K AA 09/01/2014, converted to regular approval 20/11/2015 (FDA Verified clinical benefit list); label 1.2 BRAF V600E or V600K. Source
FDA, 2018
adjuvant, BRAF V600E or V600K, lymph node involvement, after complete resection Label 1.3 wording: melanoma with lymph node involvement following complete resection (not 'stage III'). Year confirmed: FDA approval announced 30/04/2018. Source
EU (EMA), 2015
unresectable or metastatic, BRAF V600 mutation WS/0736, EC decision 25/08/2015. Source
EU (EMA), 2018
adjuvant, stage III, BRAF V600 mutation WS/1274, EC decision 27/08/2018. Source
TafinlarBroader labeltrametinib page 		BRAF V600E melanoma Approved 2014 Approved 2015

In the US approval report

COMBI-d and COMBI-v vs dabrafenib (COMBI-d); vemurafenib (COMBI-v)
PFS 9.3 months (COMBI-d); 11.4 months (COMBI-v) vs 8.8 months; 7.3 monthsResponse 64% vs 51% (COMBI-v)

Stopped for side effects 11% (COMBI-d)

Trial details and side effects
Patients
BRAF V600E or V600K melanoma (NCT01584648)
Most common side effects
pyrexia, rash, chills, headache, arthralgia, cough (559 (pooled) patients)
Notes
Dabrafenib with trametinib. Efficacy from the 2015 approval report; side effects from the Tafinlar US label rev. 03/2025.
Source
US approval report

In the EU product information

COMBI-d and COMBI-v vs dabrafenib (COMBI-d); vemurafenib (COMBI-v), 211 vs 212 (COMBI-d); 352 vs 352 (COMBI-v)
PFS 10.2 months (COMBI-d); 12.1 months (COMBI-v) vs 8.8 months; 7.3 months, HR 0.73 (0.59-0.91) COMBI-d; 0.62 (0.52-0.74) COMBI-vResponse 69% vs 54% (COMBI-d); 67% vs 53% (COMBI-v)OS 25.8 months (COMBI-d); 26.0 months (COMBI-v) vs 18.7 months; 17.8 months, HR 0.80 (0.63-1.01) COMBI-d; 0.70 (0.58-0.84) COMBI-v

Trial details and side effects
Patients
BRAF V600E or V600K melanoma (NCT01584648)
Most common side effects
pyrexia, rash, chills, headache, arthralgia, cough (559 (pooled) patients)
Notes
EU SmPC section 5.1 (5-year analyses). Side effects from the US label.
Source
EU product information

In the EU product information

COMBI-AD vs placebo, 438 vs 432 patients
RFS not reached vs 16.6 months, HR 0.47 (0.39-0.58)OS HR 0.80 (0.62-1.01), not significant

Trial details and side effects
Patients
resected stage III BRAF V600E or V600K melanoma (NCT01682083)
Most common side effects
pyrexia 63%, fatigue 59%, nausea 40%, headache 39%, rash 37%, chills 37% (435 patients)
Notes
EU SmPC section 5.1 (COMBI-AD); updated RFS HR 0.51 (0.42-0.61). Side effects from the US label.
Source
EU product information
dabrafenib with trametinib
FDA, 2023
BRAF V600E, requiring systemic therapy, age >=1 FDA approval 16/03/2023 (regular; label 1.7). Source
EU (EMA), 2023
low-grade glioma needing systemic therapy, and high-grade glioma after >=1 prior treatment, BRAF V600E Finlee MA 15/11/2023 covering LGG (needing systemic therapy) and HGG (after >=1 prior radiation and/or chemotherapy), BRAF V600E, age >=1. Trametinib paediatric formulation is Spexotras in the EU. Source
Finlee, Tafinlartrametinib page 		BRAF V600E paediatric low-grade glioma Approved 2023 Approved 2023

Study G2201 (LGG cohort) vs carboplatin + vincristine, more than 100 children
PFS 20 months vs 7 monthsResponse 47% vs 11%

Serious side effects 40%Stopped for side effects 4%

Trial details and side effects
Patients
BRAF V600E paediatric low-grade glioma needing systemic therapy (NCT02684058)
Most common side effects
pyrexia 68%, rash 51%, headache 47%, vomiting 34%, musculoskeletal pain 34%, fatigue 33% (73 patients)
Notes
Dabrafenib with trametinib. Serious side effects 47% vs 94% with chemotherapy in the trial report. Side effects from the Tafinlar US label rev. 03/2025.
Source
US approval report
dabrafenib with trametinib
FDA, 2022
unresectable or metastatic BRAF V600E, progressed after prior treatment, age >=6 (later >=1) AA 22/06/2022, still on FDA Ongoing accelerated approvals list; label 1.6 now covers adults and children >=1 year (expanded 16/03/2023). No EU tumour-agnostic equivalent. Source
Tafinlartrametinib page 		BRAF V600E solid tumours (tumour-agnostic) Approved 2022 accelerated Not approved

BRF117019, NCI-MATCH and CTMT212X2101 single-arm, 131 adults; 36 children
Response 41% (adults); 25% (children) (33-50; 12-42)Lasting in children, 78% of responses lasted 6 months or more

Trial details and side effects
Patients
BRAF V600E solid tumours other than colorectal cancer, after prior treatment (NCT02034110)
Most common side effects
pyrexia, fatigue, nausea, rash, chills, headache, haemorrhage, cough, vomiting, constipation, diarrhoea, myalgia, arthralgia, oedema
Notes
Dabrafenib with trametinib, accelerated approval (June 2022). FDA approval summary; side effects listed are those in 20% or more of adults.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRAF V600E 32 115 Phase 4
NTRK1/2/3 fusion 3 3 Phase 4
ALK fusion 2 2 Phase 2
KRAS G12C 2 4 Phase 2
RET fusion or mutation 2 2 Phase 4
ROS1 fusion 2 2 Phase 2
EGFR exon 20 insertion 1 1 Phase 2
KRAS G12D 1 3 Phase 1/2
MSI-H / dMMR 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of dabrafenib.

  1. Immuneering 1
  2. Novartis 1

Trials

33 of 116 trials shown

  1. Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

    Not yet recruiting Phase 4 Fujian Medical University Started 2025Primary completion 2027-12 NCT07010393

    dabrafenib FDA EUtrametinib FDA EUselpercatinibpralsetiniblenvatiniblarotrectinibanlotinibpembrolizumabsintilimabcabozantinibBemosuzumab

    BRAF V600E mutation

    BRAF V600ERET fusion or mutationNTRK1/2/3 fusionThyroid Neoplasms

  2. Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma

    Not yet recruiting Phase 2/3 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Started 2025Primary completion 2028-10 NCT06819605

    dabrafenib FDA EUtrametinib FDA EU

    Presence of BRAF V600E mutation confirmed by next-generation sequencing (NGS) in tumor tissue.

    BRAF V600EAmeloblastoma

  3. Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

    Recruiting Phase 3 ECOG-ACRIN Cancer Research Group Started 2024Primary completion 2030-09 NCT06475989

    cabozantinibdabrafenib FDA EUtrametinib FDA EU

    Patient must have differentiated thyroid cancer (DTC) with BRAF V600E mutation as determined by local testing, including the following subtypes (Note: results …

    BRAF V600ERefractory Differentiated Thyroid Gland Carcinoma

  4. Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer

    Active, not recruiting Phase 3 Novartis Started 2021Primary completion 2025-01 NCT04940052

    dabrafenib FDA EUtrametinib FDA EU

    BRAF V600E mutation-positive tumor sample as per central laboratory result

    BRAF V600EDifferentiated Thyroid Cancer (DTC)

  5. Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

    Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2015Primary completion 2023-09 NCT02224781

    dabrafenib FDA EUipilimumabnivolumabtrametinib FDA EU

    Patients must have BRAF V600 mutation, identified by a Food and Drug Administration (FDA)-approved test at a Clinical …

    BRAF V600EClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma

  6. A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2027-12 NCT07506109

    ipilimumabsintilimabcetuximab FDA EUdabrafenib FDA EU

    Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.

    BRAF V600EBRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable)

  7. Pulsed Stereotactic Ablative Radiotherapy (PULSAR) With Systematic Therapy for Thyroid Cancer

    Not yet recruiting Phase 2 Washington University School of Medicine Started 2026Primary completion 2029-04 NCT07886905

    dabrafenib FDA EUtrametinib FDA EUpembrolizumab

    BRAF-V600E positive by IHC.

    BRAF V600EAnaplastic Thyroid Carcinoma, Thyroid Cancer, Thyroid Carcinoma

  8. A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer

    Active, not recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2025Primary completion 2027-11 NCT06967155

    dabrafenib FDA EUtrametinib FDA EUcetuximab FDA EUoxaliplatinirinotecanleucovorinfluorouracil

    …nib and Trametinib, Anti-EGFR in the Second Line of Treatment of Patients With Metastatic BRAF V600E- Mutated Colorectal Cancer.

    BRAF V600ENeoplasms

  9. A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

    Recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2025Primary completion 2027-11 NCT06978400

    mFOLFOX6dabrafenib FDA EUcetuximab FDA EUpanitumumab

    Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation

    BRAF V600ENeoplasms

  10. MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas

    Recruiting Phase 1/2 Ann & Robert H Lurie Children's Hospital of Chicago Started 2025Primary completion 2028-12 NCT06712875

    trametinib FDA EUnivolumabdabrafenib FDA EU

    …atients with histologically confirmed diagnosis of pediatric low-grade glioma harboring a BRAFV600 mutation that is recurrent or progressive OR

    BRAF V600ELow Grade Glioma, High Grade Glioma

  11. Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

    Recruiting Phase 2 University of California, San Francisco Started 2025Primary completion 2032-03 NCT07110246

    dabrafenib FDA EUtrametinib FDA EU

    …must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing

    BRAF V600EBRAF V600 Mutation, Low-grade Glioma, Low Grade Glioma of Brain, Recurrent Low Grade Glioma

  12. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06563999

    sunvozertinib FDAcrizotinibpralsetiniblarotrectinibsavolitinibpyrotinibdabrafenibtrametinibglecirasibensartinib

    Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK …

    EGFR exon 20 insertionKRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionLung Cancer Stage III, Mutation

  13. Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma

    Recruiting Phase 2 Eva Marie Erfurth, MD, PhD Started 2023Primary completion 2027-09 NCT05525273

    dabrafenib FDA EUtrametinib FDA EU

    BRAF mutated V600E (valine 600 glutamine), verified immunohistochemically and by molecular genetic analysis

    BRAF V600EStatus may be outdated, last updated 2024-02-14Craniopharyngioma

  14. Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

    Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Started 2023Primary completion 2026-12 NCT06653517

    dabrafenib FDA EUtrametinib FDA EU

    Diagnosed with solid/multicystic type ameloblastoma with confirmed BRAF V600E mutation by next-generation sequencing (NGS);

    BRAF V600EStatus may be outdated, last updated 2024-10-22Ameloblastoma, BRAF V600E Mutation Positive

  15. NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)

    Recruiting Phase 2 Leiden University Medical Center Started 2023Primary completion 2027-01 NCT06079333

    dabrafenib FDA EUtrametinib FDA EU

    Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.

    BRAF V600EStatus may be outdated, last updated 2023-10-12Anaplastic Thyroid Cancer

  16. A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors

    Active, not recruiting Phase 1/2 Immuneering Started 2022Primary completion 2027-06 NCT05585320

    atebimetinibgemcitabinenab-paclitaxelFOLFIRINOXdabrafenibpembrolizumab

    …sectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC)

    KRAS G12CKRAS G12DBRAF V600EAdvanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC)

  17. Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2021Primary completion 2028-10 NCT04675710

    dabrafenib FDA EUpembrolizumabtrametinib FDA EU

    Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue…

    BRAF V600EThyroid Gland Anaplastic Carcinoma, Thyroid Gland Squamous Cell Carcinoma

  18. Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment

    Active, not recruiting Phase 1/2 National Cancer Institute (NCI) Started 2021Primary completion 2025-10 NCT04557956

    dabrafenib FDA EUTazemetostat Hydrobromidetrametinib FDA EU

    Patient must have a diagnosis of BRAF\^V600E/K-mutated metastatic melanoma

    BRAF V600EClinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma

  19. A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration

    Active, not recruiting Phase 1/2 Pediatric Brain Tumor Consortium Started 2020Primary completion 2026-10 NCT04201457

    dabrafenib FDA EUtrametinib FDA EUhydroxychloroquine

    Stratum 1 LGG or HGG with BRAF V600E/D/K mutation

    BRAF V600ELow Grade Glioma (LGG) of Brain With BRAF Aberration, High Grade Glioma (HGG) of the Brain With BRAF Aberration, Low Grade Glioma of Brain With Neurofibromatosis Type 1

  20. Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2020Primary completion 2027-06 NCT04238624

    dabrafenib FDA EUtrametinib FDA EU

    Pathological (histologically or cytologically) proven diagnosis of BRAF-V600E mutant ATC (a diagnosis that is noted to be consistent with ATC is acceptable)

    BRAF V600EAnaplastic Thyroid Cancer, Thyroid Cancer, BRAF Gene Mutation, BRAF Mutation-Related Tumors

  21. PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2020Primary completion 2027-09 NCT04544111

    trametinib FDA EUdabrafenib FDA EUspartalizumab

    … the patient's thyroid tumors (primary tumor, recurrent tumor, or metastases) possesses a BRAFV600- mutation (e.g.

    BRAF V600EThyroid Cancer, Thyroid Cancer, Follicular, Papillary Thyroid Cancer, Follicular Thyroid Cancer

  22. A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

    Recruiting Phase 2 Centre Leon Berard Started 2020Primary completion 2026-10 NCT04116541

    siremadlinribociclibcabozantinibalectinibregorafenibtrametinib FDA EUdabrafenib FDA EUAvapritinib

    …r amplification and/or rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and/or CSFR1, and/or amplification of the ligands, an…

    BRAF V600EALK fusionROS1 fusionNTRK1/2/3 fusionMalignant Solid Tumor

  23. Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2027-09 NCT03919071

    dabrafenib FDA EUtrametinib FDA EU

    Newly diagnosed high-grade glioma with BRAF\^V600-mutation

    BRAF V600EAnaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified, Anaplastic Ganglioglioma, Anaplastic Pleomorphic Xanthoastrocytoma

  24. Melanoma Metastasized to the Brain and Steroids

    Recruiting Phase 2 Inge Marie Svane Started 2018Primary completion 2024-06 NCT03563729

    pembrolizumabipilimumabnivolumabencorafenib FDA EUbinimetinib FDA EUdabrafenib FDA EUtrametinib FDA EU

    For arm E specifically: Tumor cells must harbor BRAF mutation.

    BRAF V600EStatus may be outdated, last updated 2023-07-13Malignant Melanoma

  25. Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma

    Active, not recruiting Phase 2 Melanoma Institute Australia Started 2017Primary completion 2022-01 NCT02858921

    dabrafenib FDA EUtrametinib FDA EUpembrolizumab

    A positive V600E immunohistochemistry stain at study entry should be formally quantified with a local mole…

    BRAF V600EMelanoma

  26. Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2016Primary completion 2023-11 NCT04439292

    dabrafenib FDA EUtrametinib FDA EU

    Patients must have a BRAF V600E or, V600K, V600R or V600D mutation, or another aberration, as identified via the MATCH Ma…

    BRAF V600EAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

  27. Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2016Primary completion 2027-12 NCT02910700

    binimetinib FDA EUdabrafenib FDA EUencorafenib FDA EUnivolumabtrametinib FDA EU

    … With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    BRAF V600EMetastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7

  28. Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2027-12 NCT02465060

    adavosertibafatinibbinimetinibcapivasertibcopanlisibcrizotinibdabrafenibDasatinibdefactiniberdafitinibfexagratinibipatasertib

    …candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…

    MSI-H / dMMRAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma

  29. Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2014Primary completion 2027-03 NCT02196181

    dabrafenib FDA EUtrametinib FDA EU

    …ts must have histologically or cytologically confirmed stage IV or unresectable stage III BRAF V600E or BRAF V600K mutant melanoma

    BRAF V600EStage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Melanoma

  30. Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2014Primary completion 2027-04 NCT02231775

    dabrafenib FDA EUtrametinib FDA EU

    … Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation

    BRAF V600EStage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7

  31. Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

    Active, not recruiting Phase 1/2 National Cancer Institute (NCI) Started 2014Primary completion 2027-12 NCT01989585

    dabrafenib FDA EUnavitoclaxtrametinib FDA EU

    Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using validated, commercially available assay performed …

    BRAF V600EClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Malignant Solid Neoplasm, Metastatic Melanoma

  32. Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

    Recruiting Phase 1 Rina Plattner Started 2022Primary completion 2028-07 NCT04903119

    Nilotinib 100mgNilotinib 200mgNilotinib 300mgNilotinib 400mgdabrafenib FDA EUtrametinib FDA EUencorafenib FDA EUbinimetinib FDA EU

    3.1.2 Patients must have a BRAF V600 mutation.

    BRAF V600EMetastatic Melanoma, BRAF Gene Mutation

  33. Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2013Primary completion 2026-04 NCT01947023

    dabrafenib FDA EUlapatinib

    …o be tested with any Food and Drug Administration (FDA)-approved test (such as Cobas 4800 BRAF V600 Mutation Test)

    BRAF V600EMetastatic Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma