marked.bio

MEK inhibitor · small molecule

trametinib

42 active trials across 11 of our biomarkers, targeting MEK1/2. 11 active approvals for a biomarker on marked.bio.

Also known as GSK1120212, JTP-74057, Mekinist.

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
Tafinlardabrafenib 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
Tafinlardabrafenib 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
Tafinlardabrafenib 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 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 labeldabrafenib 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, Tafinlardabrafenib 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
Tafinlardabrafenib 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 31 101 Phase 4
KRAS G12C 9 28 Phase 2
KRAS G12D 8 27 Phase 1/2
NTRK1/2/3 fusion 3 3 Phase 4
ALK fusion 2 3 Phase 2
EGFR exon 19 deletion / L858R 2 6 Phase 1
RET fusion or mutation 2 2 Phase 4
ROS1 fusion 2 3 Phase 2
EGFR exon 20 insertion 1 1 Phase 2
MET exon 14 skipping 0 1 –
MSI-H / dMMR 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of trametinib.

  1. Novartis 3
  2. Bayer 1
  3. Amgen 1
  4. Genfit 1
  5. Boehringer Ingelheim 1
  6. Xynomic Pharmaceuticals 1

Trials

42 of 133 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. 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

  7. 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

  8. 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

  9. XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation

    Not yet recruiting Phase 1/2 Xynomic Pharmaceuticals Started 2025Primary completion 2027-12 NCT05275374

    XP-102trametinib FDA EU

    Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid …

    BRAF V600ECancer, BRAF V600 Mutation, Melanoma, Colorectal Cancer

  10. 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

  11. 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

  12. Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

    Not yet recruiting Phase 1/2 Shanghai Chest Hospital Started 2024Primary completion 2026-06 NCT06456138

    trametinibanlotinibtislelizumab

    KRAS mutation positive detected by ARMS or NGS;

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-06-13KRAS Mutation-Related Tumors, Advanced Lung Cancer, Refractory Tumor

  13. Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma

    Recruiting Phase 1/2 Genfit Started 2023Primary completion 2027-12 NCT05874414

    trametinib

    Histologically confirmed intrahepatic CCA with a documented KRAS mutation.

    KRAS G12CKRAS G12DCholangiocarcinoma

  14. 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

  15. 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

  16. 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

  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. Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

    Active, not recruiting Phase 2 Novartis Started 2020Primary completion 2027-02 NCT04417621

    naporafenibLTT462trametinib FDA EUribociclib

    Participants with BRAFV600 mutant disease:

    BRAF V600EMelanoma

  25. 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

  26. Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2017Primary completion 2027-01 NCT03087071

    panitumumab FDAtrametinib

    may have a concomitant mutation in KRAS, NRAS, or BRAF, if there is at least a 5-fold higher allele frequency of the most prevale…

    KRAS G12CKRAS G12DEGFR NP_005219.2:p.S492R, KRAS Gene Mutation, MAP2K1 Gene Mutation, Metastatic Colorectal Adenocarcinoma

  27. 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

  28. Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2016Primary completion 2019-05 NCT02642042

    docetaxeltrametinib

    DISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or …

    KRAS G12CKRAS G12DKRAS Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7

  29. 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

  30. 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

  31. Testing Trametinib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol R)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2019-03 NCT04439279

    trametinib FDA EU

    …: Phase II Study of Trametinib in Patients With BRAF Fusions, or With NonV600E, Non-V600K BRAF Mutations

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

  32. Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors

    Active, not recruiting Phase 1/2 National Cancer Institute (NCI) Started 2014Primary completion 2022-12 NCT02079740

    navitoclaxtrametinib

    Patients must have histologically- or cytologically-confirmed diagnosis of KRAS or NRAS mutation-positive malignancy that is metastatic or unresectable and for which standard curative me…

    KRAS G12CKRAS G12DMetastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  33. Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2014Primary completion 2021-08 NCT02152995

    trametinib

    A Phase 2 Study of Trametinib in Combination With Radioiodine (RAI) for RAS Mutant or RAS/RAF Wild-Type, RAI-Refractory Recurrent and/or Metastatic Thyroid Cancers

    KRAS G12CKRAS G12DMetastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma

  34. 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

  35. 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

  36. 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

  37. A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

    Recruiting Phase 1 Bayer Started 2025Primary completion 2027-08 NCT06804824

    VVD-159642sotorasibtrametinib

    any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing

    EGFR exon 19 deletion / L858RAdvanced Solid Tumors

  38. Imatinib and Trametinib for KRAS-mutated Solid Tumor

    Recruiting Phase 1 China Medical University Hospital Started 2025Primary completion 2028-03 NCT06962254

    imatinibtrametinib

    Imatinib and Trametinib for KRAS-mutated Solid Tumor

    KRAS G12DSolid Tumor Cancer

  39. 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

  40. Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

    Active, not recruiting Phase 1 Amgen Started 2019Primary completion 2026-12 NCT04185883

    sotorasib FDA EUtrametinibvociprotafibafatinibpembrolizumabpanitumumab FDAcarboplatinpemetrexeddocetaxelpaclitaxelatezolizumabpalbociclib

    Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requireme…

    KRAS G12CAdvanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

  41. A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

    Active, not recruiting Phase 1 Boehringer Ingelheim Started 2019Primary completion 2027-03 NCT04111458

    BI 1701963trametinib

    Previously-identified activating Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation in tumour tissue or blood prior to screening

    KRAS G12CKRAS G12DSolid Tumors, KRAS Mutation; SOS1

  42. Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

    Active, not recruiting Phase 1 Novartis Started 2018Primary completion 2026-10 NCT03333343

    nazartinibtrametinibribociclibnaporafenibcapmatinibgefitinib FDA EU

    …tologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.

    EGFR exon 19 deletion / L858REGFR-mutant Non-small Cell Lung Cancer