Mekinist

(Trametinib)

ApprovedSmall molecule

Trametinib is used to treat certain types of cancer, including melanoma and lung cancer, by blocking proteins that help cancer cells grow and divide.[2] Mekinist is currently approved and in use across 52 indications[4].[1]

Mekinist is one of 746 small molecule programs targeting Ameloblastoma. It is currently in Approved.

Indications

217

Total Trials

Active Trials

745

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AmeloblastomaCompleted

Erectile DysfunctionActive, not recruiting

Anaplastic AstrocytomaActive, not recruiting

OsteosarcomaRecruiting

HistiocytosisActive, not recruiting

Metastatic MelanomaCompleted

NeuroblastomaActive, not recruiting

Uveal MelanomaWithdrawn

Metastatic Malignant Neoplasm in the BrainActive, not recruiting

Low Grade GliomaRecruiting

AmeloblastomaPhase 2

Completed

Erectile DysfunctionPreclinical

Active, not recruiting

Anaplastic AstrocytomaPhase 2

Active, not recruiting

OsteosarcomaPhase 2

Recruiting

HistiocytosisPhase 2

Active, not recruiting

Metastatic MelanomaPhase 2

Completed

NeuroblastomaPreclinical

Active, not recruiting

Uveal MelanomaPhase 2

Withdrawn

Metastatic Malignant Neoplasm in the BrainPhase 1

Active, not recruiting

Low Grade GliomaPhase 2

Recruiting

Showing 10 of 52 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Mekinist

Novartis

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Phase 1Active, not recruiting

ESS

NCT05907304

Phase 2Recruiting

Hypertrophic Cardiomyopathy

NCT06555237

Phase 3Active, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8

NCT02224781

Phase 2Active, not recruiting

Treatment

NCT04439292

Phase 2Active, not recruiting

Metastatic Melanoma

NCT03149029

Clinical

Trials by Indication[1]

Melanoma44 trials

Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

Withdrawn·UUniversity of Louisville·Phase 1/2·NCT02143050

Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 1/2·NCT03754179·63 enrolled

Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma

Terminated·NNYU Langone Health·Phase 1/2·NCT03580382·3 enrolled

Show 41 more trials

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01940809·15 enrolled

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·MM.D. Anderson Cancer Center·Phase 2·NCT02910700·52 enrolled

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Completed· Novartis logo

Novartis·Phase 3·NCT01584648·423 enrolled

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04310397·4 enrolled

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Completed· Novartis logo

Novartis·Phase 2·NCT02039947·127 enrolled

Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

Unknown status·TThe Netherlands Cancer Institute·Phase 2·NCT02625337·32 enrolled

A Clinical Trial of Patients With Melanoma

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT02915666

Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Terminated·CCanadian Cancer Trials Group·Phase 2·NCT02974803·6 enrolled

INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

Terminated·MMassachusetts General Hospital·Phase 1·NCT03272464·1 enrolled

Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma

Completed· Novartis logo

Novartis·Phase 2·NCT02083354·77 enrolled

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Terminated· Novartis logo

Novartis·Phase 1·NCT02974725·241 enrolled

A Phase 1B Clinical Trial of Trametinib Plus Digoxin in Patients With Unresectable or Metastatic BRAF Wild-type Melanoma

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT02138292·27 enrolled

Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma

Withdrawn· GSK logo

GSK·Phase 1·NCT02447939

Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03026517·18 enrolled

pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE

Unknown status·MMelanomaPRO, Russia··NCT05171374·500 enrolled

Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT02296112·9 enrolled

Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma

Completed· GSK logo

GSK·Phase 1·NCT01767454·38 enrolled

Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

Terminated·VVanderbilt-Ingram Cancer Center·Phase 2·NCT01701037·13 enrolled

Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma

Unknown status·WWest Cancer Center·Phase 1·NCT03088176·4 enrolled

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Completed· Novartis logo

Novartis··NCT04961619·39 enrolled

Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT02097225·22 enrolled

Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Active, not recruiting· Novartis logo

Novartis··NCT04666272·78 enrolled

Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

No longer available· Novartis logo

Novartis··NCT04544202

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Active, not recruiting·EErasca, Inc.·Phase 3·NCT06346067·78 enrolled

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Completed· Novartis logo

Novartis·Phase 3·NCT03551626·552 enrolled

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Completed· Novartis logo

Novartis·Phase 3·NCT01682083·870 enrolled

Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03501368·27 enrolled

TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT04059224·45 enrolled

Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma

Terminated·PProf. Dr. med. Dirk Schadendorf·Phase 2·NCT02410863·10 enrolled

Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

Withdrawn·SSCRI Development Innovations, LLC·Phase 1·NCT02300935

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Withdrawn·TTriHealth Inc.·Phase 2·NCT03972046

Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites

Terminated· GSK logo

GSK·Phase 2·NCT01978236·6 enrolled

Trametinib With GSK2141795 in BRAF Wild-type Melanoma

Completed·AAdil Daud·Phase 2·NCT01941927·20 enrolled

Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

Completed·—·Phase 1/2·NCT02257424·50 enrolled

Melanoma Metastasized to the Brain and Steroids

Recruiting·IInge Marie Svane·Phase 2·NCT03563729·80 enrolled

Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

Terminated·UUniversity of California, San Francisco·Phase 2·NCT01721603·2 enrolled

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Terminated· Novartis logo

Novartis·Phase 3·NCT02967692·568 enrolled

MCS110 With BRAF/MEK Inhibition in Patients With Melanoma

Completed·—·Phase 1/2·NCT03455764·6 enrolled

A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT02130466·184 enrolled

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Recruiting· Novartis logo

Novartis·Approved·NCT03340506·100 enrolled

A Phase II, Randomised, Open Label Study of Neoadjuvant Dabrafenib, Trametinib and / or Pembrolizumab in BRAF V600 Mutant Resectable Stage IIIB/C/D (Excluding In-transit) Melanoma

Active, not recruiting·MMelanoma Institute Australia·Phase 2·NCT02858921·60 enrolled

Non-Small Cell Lung Cancer11 trials

Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Terminated·UUniversity of California, San Francisco·Phase 1·NCT03087448·9 enrolled

Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase

Terminated·—·Phase 1·NCT02258607·21 enrolled

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

Completed·UUniversity of Cologne·Phase 1·NCT03516214·18 enrolled

Show 8 more trials

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

Completed· Novartis logo

Novartis·Phase 2·NCT01336634·177 enrolled

Trametinib in Patients With Advanced Neurofibromatosis Type 1 (NF1)-Mutant Non-small Cell Lung Cancer

Terminated·UUniversity of California, San Francisco·Phase 2·NCT03232892·1 enrolled

Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01912625·16 enrolled

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

Terminated·CCollin Blakely·Phase 1·NCT05435846·3 enrolled

Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations

Completed·JJonathan Riess·Phase 1·NCT03299088·15 enrolled

Safety and Tolerability of Trametinib in Combination With Docetaxel in Japanese Subjects With Non-small Cell Lung Cancer

Withdrawn· GSK logo

GSK·Phase 1·NCT01938456

Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer

Terminated·CClovis Oncology, Inc.·Phase 1/2·NCT02580708·7 enrolled

Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03704688·12 enrolled

Metastatic Melanoma9 trials

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

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04417621·134 enrolled

Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma

Completed·MMelanoma Institute Australia·Phase 2·NCT02645149·216 enrolled

Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma

No longer available· Novartis logo

Novartis··NCT04489433

Show 6 more trials

Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma

Completed·—·Phase 2·NCT03352947·79 enrolled

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed· Pfizer logo

Pfizer··NCT05260684·716 enrolled

A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma

Completed·KKartos Therapeutics, Inc.·Phase 1·NCT02110355·31 enrolled

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

Recruiting·RRina Plattner·Phase 1·NCT04903119·30 enrolled

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Withdrawn·UUnknown Sponsor·Phase 2·NCT05299580

A Phase II Trial of Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Patients With Unresectable or Metastatic Melanoma

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT03149029·16 enrolled

Thyroid Cancer7 trials

Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT03244956·40 enrolled

Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer

Withdrawn·SSaint Petersburg State University, Russia·Phase 2·NCT04739566

Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer

Completed·BBhavana Konda·Phase 2·NCT01723202·53 enrolled

Show 4 more trials

A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)

Unknown status·OOlivia Newton-John Cancer Research Institute·Phase 2·NCT05182931·80 enrolled

Enhancing Radioiodine Incorporation Into Radio Iodine Refractory Thyroid Cancers With MAPK Inhibition

Unknown status·UUniversity Hospital, Essen·Phase 2·NCT04619316·70 enrolled

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

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Phase II Study of PDR001 in Combination With MAPK Pathway Inhibitors in Patients With Radioiodine-Refractory Thyroid Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04544111·19 enrolled

Colorectal Cancer4 trials

Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

Unknown status·MMassachusetts General Hospital·Phase 2·NCT03668431·25 enrolled

A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02399943·14 enrolled

BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)

Completed· Novartis logo

Novartis·Phase 1/2·NCT01750918·166 enrolled

Show 1 more trial

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Terminated· Novartis logo

Novartis·Phase 1·NCT04294160·122 enrolled

97 more indications

Advanced Solid Tumors4 trials

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

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT04185883·610 enrolled

A Dose Escalation Study to Assess Safety of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT01938443·34 enrolled

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Terminated· Novartis logo

Novartis·Phase 1·NCT02703571·95 enrolled

Show 1 more trial

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

Recruiting·VVividion Therapeutics, Inc.·Phase 1·NCT06804824·220 enrolled

Treatment4 trials

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439279·35 enrolled

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439292·35 enrolled

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Recruiting·TTianjin Medical University Second Hospital·Phase 2·NCT06739395·300 enrolled

Show 1 more trial

Trametinib Treatment for Complicated Vascular Anomalies

Active, not recruiting·WWest China Hospital·Phase 1/2·NCT07072403·20 enrolled

Solid Tumors4 trials

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT02065063·28 enrolled

A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

Terminated·TTurning Point Therapeutics, Inc.·Phase 1/2·NCT05071183·9 enrolled

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors

Withdrawn· GSK logo

GSK·Phase 2·NCT03266159

Show 1 more trial

A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors

Withdrawn· GSK logo

GSK·Phase 1·NCT02292732

Cutaneous Melanoma3 trials

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Completed· Novartis logo

Novartis·Phase 3·NCT01597908·704 enrolled

Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)

Completed· GSK logo

GSK·Phase 2·NCT01928940·12 enrolled

Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

No longer available· GSK logo

GSK··NCT02416232

Pancreatic Cancer3 trials

Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer

Active, not recruiting·UUniversity of Utah·Phase 1·NCT03825289·25 enrolled

PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer

Recruiting·CCancer Trials Ireland·Phase 2·NCT05518110·22 enrolled

A Study of GSK2256098 and Trametinib in Advanced Pancreatic Cancer

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02428270·16 enrolled

Combination Therapy3 trials

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Completed· Novartis logo

Novartis·Phase 2·NCT02034110·206 enrolled

Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC

Withdrawn· Novartis logo

Novartis·Phase 2·NCT02672358

A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors

Completed·CC4 Therapeutics, Inc.·Phase 1·NCT05668585·89 enrolled

Prostate Cancer3 trials

Trametinib in Treating Patients With Progressive Metastatic Hormone-Resistant Prostate Cancer

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT02881242·14 enrolled

Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT01990196·45 enrolled

Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib

No longer available·JJonsson Comprehensive Cancer Center··NCT03386071

Acute Myeloid Leukemia2 trials

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01907815·24 enrolled

A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

Completed·KKartos Therapeutics, Inc.·Phase 1·NCT02016729·36 enrolled

Phase 12 trials

Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02027961·68 enrolled

Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

Terminated·MMerrimack Pharmaceuticals·Phase 1·NCT02538627·5 enrolled

Multiple Myeloma2 trials

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01989598·25 enrolled

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT05372354·260 enrolled

Trial2 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Ameloblastoma2 trials

Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma

Completed·SStanford University·Phase 2·NCT02367859·1 enrolled

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Recruiting·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT06653517·12 enrolled

BRAF V600 Mutation2 trials

Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03794297

A Phase 2 De-escalation Study of Dabrafenib and Trametinib for Patients With BRAF V600 Mutant Low-Grade Gliomas

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT07110246·96 enrolled

Pilot Study2 trials

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Pilot Study on Trametinib for Surgical Unruptured AVMs

Unknown status·UUniversity Health Network, Toronto·Phase 2·NCT06098872·10 enrolled

Advanced Solid Tumor2 trials

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

Not yet recruiting·XXynomic Pharmaceuticals, Inc.·Phase 1/2·NCT05275374·221 enrolled

Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Recruiting·SSe Jun Park·Phase 2·NCT05876806·30 enrolled

Plexiform Neurofibroma2 trials

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

Completed· Novartis logo

Novartis·Phase 1/2·NCT02124772·139 enrolled

Treatment of NF1-related Plexiform Neurofibroma With Trametinib

Active, not recruiting·RRegion Skane·Phase 2·NCT03741101·15 enrolled

Anaplastic Thyroid Cancer2 trials

A Pilot Study of Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03085056·13 enrolled

Pulsed Stereotactic Ablative Radiotherapy (PULSAR) Combined With Targeted Systemic Therapy for Locally Advanced BRAF-V600E+ Anaplastic Thyroid Cancer

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07886905·12 enrolled

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination With Dual BRAF/MEK Inhibition in Patients With BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04557956·16 enrolled

The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH

Terminated·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04527549·5 enrolled

Tislelizumab1 trial

Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

Not yet recruiting·SShanghai Chest Hospital·Phase 1/2·NCT06456138·60 enrolled

Nivolumab1 trial

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03377361·325 enrolled

Metastatic Colorectal Cancer1 trial

Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Completed·CCentre Leon Berard·Phase 1·NCT03714958·12 enrolled

Brain Tumors1 trial

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT03434262·68 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Epithelioid Hemangioendothelioma1 trial

Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03148275·44 enrolled

Osteosarcoma1 trial

A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07477457·45 enrolled

Patients With Solid Tumors1 trial

A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT02705963·19 enrolled

Monotherapy1 trial

Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib

Terminated· GSK logo

GSK·Phase 2·NCT02314143·48 enrolled

Radiation Therapy1 trial

Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer

Completed·OOhio State University Comprehensive Cancer Center·Phase 1·NCT01740648·19 enrolled

Rosacea1 trial

Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea

Completed·—·Phase 1·NCT05616923·12 enrolled

Gallbladder Cancer1 trial

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02042443·53 enrolled

Anti-PD-1 Antibody1 trial

Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib

Withdrawn·UUniversity of Pittsburgh·Phase 1·NCT02357732

Triple-Negative Breast Cancer1 trial

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01964924·37 enrolled

Rectal Cancer1 trial

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

Completed·—·Phase 1·NCT03317119·26 enrolled

Gastrointestinal Stromal Tumor1 trial

SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)

Withdrawn·SSarcoma Alliance for Research through Collaboration·Phase 2·NCT02342600

Metastatic NSCLC1 trial

A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Completed· Novartis logo

Novartis·Phase 2·NCT04452877·40 enrolled

Neuroblastoma1 trial

MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma

Completed·HHospices Civils de Lyon·N/A·NCT03979651·29 enrolled

APL1 trial

Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

Active, not recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT04454476·15 enrolled

BRAF V600E Mutation1 trial

Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease

Completed·NNational Human Genome Research Institute (NHGRI)·Phase 2·NCT02281760·9 enrolled

Stage III1 trial

Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01902173·27 enrolled

Lung Adenocarcinoma1 trial

A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03076164·24 enrolled

Active, not recruiting·SSt. Justine's Hospital·Phase 2·NCT03363217·114 enrolled

Advanced Cancer1 trial

Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02070549·46 enrolled

Cancers1 trial

Precision Cancer Therapy in Rare Cancers

Recruiting·OOslo University Hospital·Phase 2·NCT06119789·96 enrolled

Relapsed or Refractory1 trial

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

Completed· Novartis logo

Novartis·Phase 2·NCT02684058·151 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Langerhans Cell Histiocytosis1 trial

Targeted Approach to Langerhans Cell Histiocytosis (LCH) Using MEK Inhibitor, Trametinib

Recruiting·CCook Children's Health Care System·Phase 2·NCT06582745·75 enrolled

Metastatic Colon Cancer1 trial

Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03428126·29 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Completed·PPeter Hosein, MD·Phase 1·NCT05440942·28 enrolled

Hepatocellular Cancer1 trial

Trametinib in Combination With Sorafenib in Patients With Advanced Hepatocellular Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02292173·17 enrolled

ESS1 trial

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations

Active, not recruiting·EErasca, Inc.·Phase 1·NCT05907304·86 enrolled

Solid Tumor1 trial

Imatinib and Trametinib for KRAS-mutated Solid Tumor

Recruiting·—·Phase 1·NCT06962254·10 enrolled

Hematological Malignancies1 trial

HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT05658640·26 enrolled

Endometrial Cancer1 trial

Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01935973·26 enrolled

Myelodysplastic Syndrome1 trial

Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04487106·21 enrolled

Hypertrophic Cardiomyopathy1 trial

MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies

Recruiting·MMedical University of Warsaw·Phase 2·NCT06555237·40 enrolled

Amyotrophic Lateral Sclerosis1 trial

Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Terminated·GGenuv Inc.·Phase 1/2·NCT04326283·23 enrolled

Biliary Tract Cancer1 trial

A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers

Completed· GSK logo

GSK·Phase 2·NCT01943864·20 enrolled

Nab-paclitaxel1 trial

Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

Completed· GSK logo

GSK·Phase 1·NCT01192165·169 enrolled

Pediatric1 trial

Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation

Completed· GSK logo

GSK·Phase 1·NCT01647659·18 enrolled

Venous malformation1 trial

Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Unknown status·SStanford University·Phase 2·NCT04258046·30 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Overall Response Rate1 trial

UARK 2014-08 A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib

Withdrawn·UUniversity of Arkansas·Phase 2·NCT02140840

NSCLC1 trial

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

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT03333343·105 enrolled

Solid Tumours1 trial

Pharmacokinetics of Single and Repeat Oral Doses of Trametinib in Chinese Subjects With Solid Tumours

Withdrawn· GSK logo

GSK·Phase 1·NCT02939846

Pancreatic Adenocarcinoma1 trial

Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic Adenocarcinoma

Unknown status·NNational Cancer Centre, Singapore·Phase 1·NCT04303403·48 enrolled

Tumor1 trial

MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01827384·208 enrolled

RAS Mutation1 trial

Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT04566133·2 enrolled

Anlotinib1 trial

Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients

Completed·SShanghai Chest Hospital·Phase 1·NCT04967079·33 enrolled

Apatinib1 trial

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Completed·TThe Netherlands Cancer Institute·Phase 1/2·NCT02230553·35 enrolled

Juvenile Myelomonocytic Leukemia1 trial

A Phase 2 Study of the MEK Inhibitor Trametinib (NSC# 763093) in Children With Relapsed or Refractory Juvenile Myelomonocytic Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03190915·10 enrolled

Anaplastic Astrocytoma1 trial

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03919071·58 enrolled

Meningioma1 trial

Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas: Phase 1 Study

Active, not recruiting·AAssistance Publique Hopitaux De Marseille·Phase 1·NCT03631953·32 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

KRAS Gene Mutation1 trial

A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02642042·60 enrolled

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02224781·267 enrolled

Non-Small Cell Lung Carcinoma1 trial

KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

Active, not recruiting· Novartis logo

Novartis·Preclinical·NCT07468071·25 enrolled

Stage III Cutaneous Melanoma AJCC v71 trial

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02196181·280 enrolled

KRAS G12C Mutant Solid Tumors1 trial

KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Terminated· Novartis logo

Novartis·Preclinical·NCT05358249·74 enrolled

Vascular1 trial

VATCH (Vascular Anomaly Analysis for Therapy Choice): A Phase II Study of Trametinib Treatment in Subjects With Ras/MAPK Pathway Driven Vascular Anomalies

Recruiting·CChildren's Hospital of Philadelphia·Phase 2·NCT07549646·45 enrolled

BRAF NP_004324.2:p.V600E1 trial

A Phase I Trial of Concurrent Intensity Modulated Radiation Therapy (IMRT) and Dabrafenib/Trametinib in BRAF Mutated Anaplastic Thyroid Cancer

Suspended·CCity of Hope Medical Center·Phase 1·NCT03975231·6 enrolled

Thyroid Gland Anaplastic Carcinoma1 trial

Pembrolizumab in Combination With Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-Mutated Anaplastic Thyroid Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04675710·30 enrolled

Histiocytosis1 trial

Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients With Refractory Histiocytosis or After the Failure of Vemurafenib Treatment

Active, not recruiting·AAnna Raciborska·Phase 2·NCT04943224·12 enrolled

Solid Tumors, KRAS Mutation; SOS11 trial

A Phase I Open-label Dose Escalation Trial of BI 1701963 as Monotherapy and in Combination With Trametinib in Patients With KRAS Mutated Advanced or Metastatic Solid Tumours

Active, not recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04111458·71 enrolled

Metastatic Malignant Neoplasm in the Brain1 trial

A Phase 1 Study of Trametinib in Combination With Radiation Therapy for Brain Metastases

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02015117·10 enrolled

Refractory Differentiated Thyroid Gland Carcinoma1 trial

A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT06475989·264 enrolled

Differentiated Thyroid Carcinoma1 trial

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04940052·153 enrolled

HCM1 trial

Clinical Trial of a MEK Inhibitor for RASopathy-Associated Severe Infantile Hypertrophic Cardiomyopathy: Baby MERIT

Not yet recruiting·CCarelon Research·Phase 3·NCT07817186·25 enrolled

Low Grade Glioma1 trial

Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-associated Recurrent or Progressive Gliomas in Children and Young Adults

Active, not recruiting·PPediatric Brain Tumor Consortium·Preclinical·NCT04201457·57 enrolled

Metastatic Malignant Solid Neoplasm1 trial

An Open Label, Two-Part, Phase Ib/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor Trametinib and the BCL2-Family Inhibitor Navitoclax (ABT-263) in Combination in Subjects With KRAS or NRAS Mutation-Positive Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT02079740·96 enrolled

Leukemia, Juvenile Myelomonocytic1 trial

Risk Stratified Treatment for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia: A Phase I/II Non-randomized Study of Trametinib and Azacitidine With or Without Chemotherapy (IND #164058)

Recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Preclinical·NCT05849662·58 enrolled

Metastatic Thyroid Gland Carcinoma1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02152995·34 enrolled

Diffuse Astrocytoma1 trial

An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Active, not recruiting· Novartis logo

Novartis·Approved·NCT03975829·163 enrolled

Grade 1 Glioma1 trial

A Randomized and Controlled Phase II Protocol in Non NF1 Pediatric and AYA (Adolescent and Young Adults) Patients Bearing a Newly Diagnosed Low Grade Glioma With Wild Type BRAF Gene Comparing a Daily Oral MEK Inhibitor (Trametinib) Versus Weekly Vinblastine for 18 Months

Recruiting·UUniversity Hospital, Strasbourg, France·Phase 2·NCT05180825·134 enrolled

Health1 trial

PNOC021: A Phase I Trial Evaluating the Combination of Trametinib and Everolimus in Pediatric and Young Adult Patients With Recurrent Low-Grade Gliomas and High-Grade Gliomas

Recruiting·UUniversity of California, San Francisco·Phase 1·NCT04485559·50 enrolled

Unspecified1 trial

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03899155·1,500 enrolled

Regulatory

FDA Approval Timeline[5]

May 29, 2013

MEKINIST

NDA NDA204114

Aug 13, 2014

MEKINIST

NDA NDA204114

Sep 26, 2014

MEKINIST

NDA NDA204114

Nov 20, 2015

MEKINIST

NDA NDA204114

Feb 24, 2017

MEKINIST

NDA NDA204114

Jun 22, 2017

MEKINIST

NDA NDA204114

Mar 9, 2018

MEKINIST

NDA NDA204114

Apr 30, 2018

MEKINIST

NDA NDA204114

May 4, 2018

MEKINIST

NDA NDA204114

Jul 16, 2019

MEKINIST

NDA NDA204114

Oct 6, 2019

MEKINIST

NDA NDA204114

Apr 9, 2020

MEKINIST

NDA NDA204114

Jun 23, 2020

MEKINIST

NDA NDA204114

May 7, 2021

MEKINIST

NDA NDA204114

Dec 3, 2021

MEKINIST

NDA NDA204114

Jan 28, 2022

MEKINIST

NDA NDA204114

Jan 28, 2022

MEKINIST

NDA NDA204114

May 27, 2022

MEKINIST

NDA NDA204114

Jun 22, 2022

MEKINIST

NDA NDA204114

Mar 16, 2023

MEKINIST

NDA NDA204114

Mar 16, 2023

MEKINIST

NDA NDA217513

May 26, 2023

MEKINIST

NDA NDA204114

Aug 31, 2023

MEKINIST

NDA NDA204114

Feb 27, 2024

MEKINIST

NDA NDA217513

Feb 27, 2024

MEKINIST

NDA NDA204114

Mar 29, 2024

MEKINIST

NDA NDA204114

Mar 29, 2024

MEKINIST

NDA NDA217513

Jul 11, 2024

MEKINIST

NDA NDA204114

Jul 11, 2024

MEKINIST

NDA NDA217513

Oct 1, 2024

MEKINIST

NDA NDA204114

Oct 1, 2024

MEKINIST

NDA NDA217513

Jan 24, 2025

MEKINIST

NDA NDA204114

Jan 24, 2025

MEKINIST

NDA NDA217513

Mar 7, 2025

MEKINIST

NDA NDA204114

Mar 7, 2025

MEKINIST

NDA NDA217513

Mar 19, 2025

MEKINIST

NDA NDA204114

Mar 19, 2025

MEKINIST

NDA NDA217513

Apr 7, 2025

MEKINIST

NDA NDA204114

Apr 7, 2025

MEKINIST

NDA NDA217513

Apr 21, 2025

MEKINIST

NDA NDA204114

Mar 26, 2026

MEKINIST

NDA NDA217513

Mar 26, 2026

MEKINIST

NDA NDA204114

May 7, 2026

MEKINIST

NDA NDA204114

Sources

References

[1]
ClinicalTrials.gov — 217 trial records for Trametinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mekinist drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Trametinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Trametinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204114). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dual Specificity Mitogen-Activated Protein Kinase Kinase 2 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase 1 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase; MEK1/2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Mekinist

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Melanoma44 trials

Non-Small Cell Lung Cancer11 trials

Metastatic Melanoma9 trials

Thyroid Cancer7 trials

Colorectal Cancer4 trials

Advanced Solid Tumors4 trials

Treatment4 trials

Solid Tumors4 trials

Cutaneous Melanoma3 trials

Pancreatic Cancer3 trials

Combination Therapy3 trials

Prostate Cancer3 trials

Acute Myeloid Leukemia2 trials

Phase 12 trials

Multiple Myeloma2 trials

Trial2 trials

Ameloblastoma2 trials

BRAF V600 Mutation2 trials

Pilot Study2 trials

Advanced Solid Tumor2 trials

Plexiform Neurofibroma2 trials

Anaplastic Thyroid Cancer2 trials

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Tislelizumab1 trial

Nivolumab1 trial

Metastatic Colorectal Cancer1 trial

Brain Tumors1 trial

Advanced Soft-tissue Sarcoma1 trial

Epithelioid Hemangioendothelioma1 trial

Osteosarcoma1 trial

Patients With Solid Tumors1 trial

Monotherapy1 trial

Radiation Therapy1 trial

Rosacea1 trial

Gallbladder Cancer1 trial

Anti-PD-1 Antibody1 trial

Triple-Negative Breast Cancer1 trial

Rectal Cancer1 trial

Gastrointestinal Stromal Tumor1 trial

Metastatic NSCLC1 trial

Neuroblastoma1 trial

APL1 trial

BRAF V600E Mutation1 trial

Stage III1 trial

Lung Adenocarcinoma1 trial

Pain1 trial

Uveal Melanoma1 trial

Oncology Patients1 trial

Advanced Cancer1 trial

Cancers1 trial

Relapsed or Refractory1 trial

Erectile Dysfunction1 trial

Langerhans Cell Histiocytosis1 trial

Metastatic Colon Cancer1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Hepatocellular Cancer1 trial

ESS1 trial

Solid Tumor1 trial

Hematological Malignancies1 trial

Endometrial Cancer1 trial

Myelodysplastic Syndrome1 trial

Hypertrophic Cardiomyopathy1 trial

Amyotrophic Lateral Sclerosis1 trial

Biliary Tract Cancer1 trial

Nab-paclitaxel1 trial

Pediatric1 trial

Venous malformation1 trial

Cancer1 trial

Overall Response Rate1 trial

NSCLC1 trial

Solid Tumours1 trial

Pancreatic Adenocarcinoma1 trial

Tumor1 trial

RAS Mutation1 trial