Clinical trials: BRAF V600 Mutation
Haematological Malignancy, Malignant Neoplasm
DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.
This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in…
- Conditions
- Haematological Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type
- Trial name
- DETERMINE (NCT07440290)
- Testing
- Dabrafenib, Trametinib
- Where
- 27 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Cancer Research UK
Cancer
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors
The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate).
- Trial name
- NCT01954043
- Testing
- Dabrafenib 150 mg twice a day (BID), Rabeprazole 40 mg once daily (OD), Rifampin 600 mg OD
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
BRAF V600 Mutation, Unresectable Melanoma
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation.
- Conditions
- BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma, Hepatic Impairment
- Trial name
- NCT04759846
- Testing
- Encorafenib + Binimetinib
- Where
- 7 sites in Czechia, Italy and 1 more
- Sponsor
- Pierre Fabre Medicament
Melanoma
Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma
This is an open label, single centre, phase II study of neoadjuvant drug treatment with dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer (AJCC) Stage IIIB-C BRAF V600 mutation positive…
- Trial name
- Neo Combi (NCT01972347)
- Testing
- Dabrafenib, Trametinib
- Where
- Australia
- Volunteers
- 35 people
- Sponsor
- Melanoma Institute Australia
Colorectal Cancer, Colon Cancer
Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer
AIO-KRK-0420 NeoBRAF is a single arm, multicenter, phase II trial with neoadjuvant encorafenib, binimetinib and cetuximab for patients with BRAF V600E mutated/pMMR localized colorectal cancer.
- Conditions
- Colorectal Cancer, Colon Cancer, BRAF V600E, BRAF V600 Mutation
- Trial name
- NeoBRAF (NCT05510895)
- Testing
- Binimetinib
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- AIO-Studien-gGmbH
Metastatic Cancers
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
- Trial name
- NCT02663232
- Where
- 33 sites in Spain
- Volunteers
- 264 people
- Sponsor
- Hoffmann-La Roche
Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7
Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation
This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene.
- Trial name
- NCT02231775
- Testing
- Dabrafenib, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- M.D. Anderson Cancer Center
Malignant Melanoma
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting.
- Trial name
- NCT01990248
- Where
- 80 sites in Austria, Belgium and 8 more
- Volunteers
- 339 people
- Sponsor
- Hoffmann-La Roche
Melanoma Metastatic, BRAF V600 Mutation
To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive…
- Trial name
- NCT03514901
- Testing
- Experimental combination beyond Focal Progression, Pembrolizumab or Nivolumab
- Where
- 14 sites in Italy
- Volunteers
- 120 people
- Sponsor
- Intergruppo Melanoma Italiano
Neoplasms
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent…
- Trial name
- NCT01739764
- Testing
- Vemurafenib
- Where
- 83 sites in United States, Belarus and 23 more
- Volunteers
- 215 people
- Sponsor
- Hoffmann-La Roche
Melanoma
A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])
This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with…
- Trial name
- MELANIS (NCT03139513)
- Testing
- Cobimetinib, Vemurafenib
- Where
- 33 sites in France
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Cancer
A Study to Evaluate the Effect of Repeat Oral Dosing of GSK2118436 on Cardiac Repolarization in Subjects With V600 BRAF Mutation-Positive Tumors
This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT interval [QTc] duration) as compared with…
- Trial name
- NCT01738451
- Testing
- GSK2118436 75 mg
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 50 people
- Sponsor
- GlaxoSmithKline
BRAF V600 Mutation, Low-grade Glioma
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation.
- Conditions
- BRAF V600 Mutation, Low-grade Glioma, Low Grade Glioma of Brain, Recurrent Low Grade Glioma
- Trial name
- PNOC037 (NCT07110246)
- Testing
- Dabrafenib, Trametinib, Magnetic Resonance Imaging (MRI)
- Where
- 12 sites in United States
- Volunteers
- 96 people
- Sponsor
- University of California, San Francisco
BRAF v600 Mutated Metastatic Melanoma
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020.
- Trial name
- NCT05806268
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Melanoma, Brain Metastases
E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
This is a Phase 1 study of E6201 plus dabrafenib for the treatment of CNS metastases in BRAF V600-mutated metastatic melanoma. A total of up to N=28-34 subjects with melanoma metastasized to the CNS will be included.
- Trial name
- NCT03332589
- Testing
- E6201, E6201 plus dabrafenib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Spirita Oncology, LLC
NSCLC, BRAF V600 Mutation
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.
- Conditions
- NSCLC, BRAF V600 Mutation, MET Exon 14 Mutation
- Trial name
- NCT06054191
- Testing
- Dabrafenib + Trametinib, Capmatinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Melanoma
Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma
This research study was intended to be a Phase I/II clinical trial, but the trial was terminated before the phase 1 portion was completed. Phase I clinical trials test the safety of an investigational combination of drugs.
- Trial name
- NCT01611675
- Testing
- Vemurafenib, Leflunomide
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Massachusetts General Hospital
Malignant Melanoma
A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or metastatic melanoma.
- Trial name
- NCT01910181
- Testing
- Vemurafenib
- Where
- 2 sites in China
- Volunteers
- 46 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumor, BRAF V600 Mutation
A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors
This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced…
- Trial name
- NCT05501912
- Testing
- ABM-1310
- Where
- 10 sites in China
- Volunteers
- 20 people
- Sponsor
- ABM Therapeutics Shanghai Company Limited
Melanoma, Adjuvant
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection.
- Trial name
- NCT04544202
- Testing
- Dabrafenib and Trametinib, Dabrafenib, Trametinib
- Sponsor
- Novartis Pharmaceuticals