Dabrafenib
Information
- Drug Name
- Dabrafenib
- Description
- Entry(CIViC)
- 36
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In trial NCT00880321, dabrafenib was tested in var... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | false | CIViC Evidence | detail |
| In the NCT00880321 trial using mutant BRAF inhibit... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| The Combi-v (NCT01597908) open-label, randomized p... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| In clinical trial NCT01072175, 43 patients with BR... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| BRAF mutations were identified in 9% of 108 cases ... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| non-V600 BRAF mutations can be sensitive to clinic... | BRAF |
BRAF p.Gly636Cys (p.G636C) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Gly636Cys (p.G636C) ( ENST00000646891.2, ENST00000288602.11, ENST00000496384.7, ENST00000644969.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Patients were treated with a specific RAF inhibito... | BRAF |
BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Paired pre-treatment and post-progression tumor bi... | BRAF |
BRAF V600E AMPLIFICATION ( ENST00000288602.11 ) BRAF V600E AMPLIFICATION ( ENST00000288602.11 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Patients with BRAF V600E-mutant NSCLC (n=57) were ... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a clinical trial (NCT01597908) of 704 metastati... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a clinical trial (NCT01597908) of 704 metastati... | BRAF |
BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Chemotherapy-refractory, metastatic cholangiocarci... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Two cases of patients with BRAF V600E positive cho... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Dabrafenib and trametinib combination showed durab... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this trial, 142 patients with metastatic, BRAF ... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Adjuvant dual treatment with BRAF inhibitor dabraf... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Adjuvant dual treatment with BRAF inhibitor dabraf... | BRAF |
BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Combination Dabrafenib and Trametinib treatment wa... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | AKT1 |
AKT1 p.Gln79Lys (p.Q79K) ( ENST00000554192.6, ENST00000554581.5, ENST00000402615.6, ENST00000554848.5, ENST00000555458.6, ENST00000407796.7, ENST00000349310.7, ENST00000553797.2, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) AKT1 p.Gln79Lys (p.Q79K) ( ENST00000349310.7, ENST00000402615.6, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000554848.5, ENST00000555458.6, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | BRAF | BRAF V600E/K AMPLIFICATION BRAF V600E/K AMPLIFICATION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | NRAS | NRAS MUTATION NRAS MUTATION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | KRAS | KRAS MUTATION KRAS MUTATION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | BRAF | BRAF APC BRAF APC | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a retrospective study of 44 relapsed melanoma p... | BRAF | BRAF APC BRAF APC | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this Phase III trial (NCT01584648 COMBI-d), 423... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| In this Phase III trial (NCT01584648 COMBI-d), pre... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this Phase I and II study (NCT01072175) patient... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this Phase III trial (coBRIM, NCT01689519) of 4... | BRAF |
BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Lys (p.V640K) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Interim analysis of a basket trial evaluating the ... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| A single patient with BRAF V600E/V600M bi-allelic ... | BRAF | BRAF V600E+V600M BRAF V600E+V600M | Sensitivity | true | CIViC Evidence | detail |
| In a retrospective study, authors analyzed BRAF V6... | BRAF |
BRAF V600E AMPLIFICATION ( ENST00000288602.11 ) BRAF V600E AMPLIFICATION ( ENST00000288602.11 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Melanoma cell lines harboring the RAC1 P29S hotspo... | RAC1 |
RAC1 p.Pro29Ser (p.P29S) ( ENST00000348035.9, ENST00000356142.4, ENST00000704002.1 ) RAC1 p.Pro29Ser (p.P29S) ( ENST00000348035.9, ENST00000356142.4, ENST00000704002.1 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In a patient with V600E-positive NSCLC, KRAS G12D ... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| This was a Phase I and II study (NCT01072175) of d... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| Patients with other BRAF V600 mutations also respo... | BRAF |
BRAF p.Val640Asp (p.V640D) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Asp (p.V640D) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Dabrafenib with trametinib provides higher respons... | BRAF |
BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E) ( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04940052 | Active, not recruiting | Phase 3 | Study of 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 | November 15, 2021 | June 3, 2027 |
| NCT04544111 | Active, not recruiting | Phase 2 | PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer | September 2, 2020 | September 2, 2025 |
| NCT02910700 | Active, not recruiting | Phase 2 | Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma | December 9, 2016 | December 8, 2024 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT02858921 | Active, not recruiting | Phase 2 | Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma | November 8, 2017 | November 2024 |
| NCT01723202 | Active, not recruiting | Phase 2 | Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer | November 7, 2012 | December 31, 2022 |
| NCT04452877 | Active, not recruiting | Phase 2 | A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC | August 19, 2020 | November 21, 2024 |
| NCT01947023 | Active, not recruiting | Phase 1 | Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery | September 27, 2013 | December 1, 2024 |
| NCT01972347 | Active, not recruiting | Phase 2 | Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma | October 2014 | May 2024 |
| NCT04294160 | Active, not recruiting | Phase 1 | A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer | July 22, 2020 | October 11, 2024 |
| NCT02231775 | Active, not recruiting | Phase 2 | Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation | October 22, 2014 | April 1, 2025 |
| NCT03455764 | Active, not recruiting | Phase 1/Phase 2 | MCS110 With BRAF/MEK Inhibition in Patients With Melanoma | June 22, 2018 | September 30, 2025 |
| NCT03149029 | Active, not recruiting | Phase 2 | Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma | November 27, 2017 | December 31, 2024 |
| NCT01989585 | Active, not recruiting | Phase 1/Phase 2 | Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma | March 24, 2014 | December 31, 2024 |
| NCT03026517 | Active, not recruiting | Phase 1 | Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma | January 2017 | January 2025 |
| NCT02967692 | Active, not recruiting | Phase 3 | A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma | February 17, 2017 | August 26, 2024 |
| NCT04489433 | Available | Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma | |||
| NCT04507919 | Available | Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive Advanced Non-Small Cell Lung Cancer | |||
| NCT04544202 | Available | Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection | |||
| NCT02083354 | Completed | Phase 2 | Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma | March 18, 2014 | April 19, 2021 |
| NCT01584648 | Completed | Phase 3 | A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma | May 4, 2012 | February 28, 2019 |
| NCT01597908 | Completed | Phase 3 | Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma | June 4, 2012 | April 25, 2019 |
| NCT01677741 | Completed | Phase 1/Phase 2 | A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects | May 23, 2013 | December 4, 2020 |
| NCT01682083 | Completed | Phase 3 | Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). | January 8, 2013 | July 31, 2023 |
| NCT01682213 | Completed | Phase 2 | Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation | September 2012 | May 2019 |
| NCT01713972 | Completed | Phase 1 | Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors | November 19, 2012 | December 26, 2018 |
| NCT01750918 | Completed | Phase 1/Phase 2 | BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC) | December 19, 2012 | June 18, 2020 |
| NCT01767454 | Completed | Phase 1 | Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma | February 12, 2013 | September 4, 2015 |
| NCT01928940 | Completed | Phase 2 | 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) | August 15, 2013 | July 4, 2016 |
| NCT02027961 | Completed | Phase 1 | Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone | December 20, 2013 | April 24, 2018 |
| NCT02034110 | Completed | Phase 2 | Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers | March 12, 2014 | December 10, 2021 |
| NCT02039947 | Completed | Phase 2 | Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain | February 21, 2014 | February 14, 2018 |
| NCT01336634 | Completed | Phase 2 | 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. | August 5, 2011 | January 7, 2021 |
| NCT02110355 | Completed | Phase 1 | A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma | December 19, 2014 | December 27, 2018 |
| NCT02124772 | Completed | Phase 1/Phase 2 | 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 | January 15, 2015 | December 29, 2020 |
| NCT02130466 | Completed | Phase 1/Phase 2 | 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) | May 29, 2014 | July 14, 2021 |
| NCT02367859 | Completed | Phase 2 | Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma | July 17, 2017 | June 26, 2019 |
| NCT02684058 | Completed | Phase 2 | 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 | December 28, 2017 | April 28, 2023 |
| NCT02852239 | Completed | Phase 1 | Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment | December 19, 2016 | September 27, 2019 |
| NCT03352947 | Completed | Phase 2 | Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma | November 3, 2017 | November 27, 2020 |
| NCT03551626 | Completed | Phase 3 | 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 | August 29, 2018 | September 16, 2021 |
| NCT03553329 | Completed | Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK | June 2, 2018 | June 2, 2018 | |
| NCT04059224 | Completed | Phase 2 | TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma | January 28, 2019 | June 30, 2023 |
| NCT04310397 | Completed | Phase 2 | Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma | January 29, 2020 | October 9, 2023 |
| NCT05260684 | Completed | Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US | January 17, 2022 | December 31, 2023 | |
| NCT02416232 | No longer available | Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma | |||
| NCT06264778 | Not yet recruiting | Phase 3 | Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma | March 1, 2024 | December 31, 2025 |
| NCT05171374 | Recruiting | pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE | September 30, 2021 | September 30, 2024 | |
| NCT03091257 | Recruiting | Phase 1 | A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma | June 21, 2017 | September 15, 2024 |
| NCT03340506 | Recruiting | Phase 4 | Dabrafenib and/or Trametinib Rollover Study | December 28, 2017 | December 21, 2027 |
| NCT03563729 | Recruiting | Phase 2 | Melanoma Metastasized to the Brain and Steroids | June 6, 2018 | June 6, 2028 |
| NCT03975231 | Recruiting | Phase 1 | Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer | September 14, 2020 | April 30, 2025 |
| NCT03975829 | Recruiting | Phase 4 | Pediatric Long-Term Follow-up and Rollover Study | November 4, 2019 | May 29, 2026 |
| NCT05388877 | Recruiting | Phase 1 | E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma | September 30, 2022 | December 2025 |
| NCT04116541 | Recruiting | Phase 2 | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. | January 28, 2020 | November 2026 |
| NCT04201457 | Recruiting | Phase 1/Phase 2 | A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration | January 17, 2020 | June 30, 2029 |
| NCT04238624 | Recruiting | Phase 2 | Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer | January 20, 2020 | June 20, 2024 |
| NCT05876806 | Recruiting | Phase 2 | Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations | June 20, 2023 | March 2026 |
| NCT04666272 | Recruiting | 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 | December 31, 2020 | July 31, 2029 | |
| NCT04675710 | Recruiting | Phase 2 | Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer | June 24, 2021 | June 30, 2024 |
| NCT04903119 | Recruiting | Phase 1 | Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma | June 1, 2022 | March 31, 2027 |
| NCT04961619 | Recruiting | Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma. | December 1, 2021 | December 30, 2024 | |
| NCT05159245 | Recruiting | Phase 2 | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs | December 10, 2021 | November 25, 2026 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT04418167 | Suspended | Phase 1 | JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations | June 18, 2020 | December 17, 2024 |
| NCT02873650 | Terminated | Phase 1 | Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment | December 20, 2016 | April 8, 2019 |
| NCT01701037 | Terminated | Phase 2 | Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery | January 2013 | April 2015 |
| NCT03272464 | Terminated | Phase 1 | INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors. | May 29, 2019 | December 27, 2019 |
| NCT01721603 | Terminated | Phase 2 | Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets | April 2013 | January 2016 |
| NCT02974803 | Terminated | Phase 2 | Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases | February 9, 2018 | July 29, 2020 |
| NCT02314143 | Terminated | Phase 2 | Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib | November 13, 2013 | January 19, 2017 |
| NCT03391050 | Terminated | Phase 1/Phase 2 | A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma | January 18, 2018 | August 8, 2018 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT02052193 | Terminated | Phase 2 | Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study | January 2014 | December 15, 2014 |
| NCT01940809 | Terminated | Phase 1 | Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery | August 28, 2013 | March 4, 2022 |
| NCT04801966 | Terminated | N/A | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study | September 23, 2021 | December 30, 2022 |
| NCT02410863 | Terminated | Phase 2 | Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma | November 2015 | August 2018 |
| NCT01907802 | Terminated | Phase 1 | Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction | August 23, 2013 | December 16, 2015 |
| NCT02625337 | Unknown status | Phase 2 | Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients | January 2016 | December 2018 |
| NCT02097225 | Unknown status | Phase 1 | Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery | May 29, 2014 | |
| NCT03088176 | Unknown status | Phase 1 | Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma | June 25, 2017 | June 30, 2021 |
| NCT03239015 | Unknown status | Phase 2 | Efficacy and Safety of Precision Therapy in Refractory Tumor | January 1, 2017 | December 31, 2023 |
| NCT03244956 | Unknown status | Phase 2 | Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer | December 27, 2017 | December 2022 |
| NCT03668431 | Unknown status | Phase 2 | Dabrafenib + Trametinib + PDR001 In Colorectal Cancer | October 15, 2018 | December 1, 2022 |
| NCT03754179 | Unknown status | Phase 1/Phase 2 | Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma | January 23, 2018 | July 1, 2022 |
| NCT02143050 | Withdrawn | Phase 1/Phase 2 | Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients | September 2014 | November 17, 2017 |
| NCT02672358 | Withdrawn | Phase 2 | Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC | September 3, 2018 | December 7, 2020 |
| NCT05299580 | Withdrawn | Phase 2 | "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)" | February 18, 2021 | March 30, 2023 |
| NCT02915666 | Withdrawn | Phase 1 | A Clinical Trial of Patients With Melanoma | October 2016 | July 17, 2017 |
| NCT04739566 | Withdrawn | Phase 2 | Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer | January 22, 2021 | December 22, 2023 |
| NCT02357732 | Withdrawn | Phase 1 | Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib | August 2015 | August 2015 |
| NCT02447939 | Withdrawn | Phase 1 | Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma | May 2017 | December 2018 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Tafinlar
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2013
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2016
- Target (Drug list of Screening Committee of Anticancer Drugs)
- BRAF(V600E)
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- メラノーマ（BRAF/V600E)