Clinical trials: BRAF V600 Mutation
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, Ependymoma
- Trial name
- NCT03220035
- Testing
- Laboratory Biomarker Analysis, Vemurafenib
- Where
- 116 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Anaplastic Thyroid Cancer, ATC
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).
- Trial name
- NCT05102292
- Testing
- HLX208
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Shanghai Henlius Biotech
Malignant Melanoma
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples.
- Trial name
- NCT01744860
- Where
- 12 sites in France
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
BRAF V600 Mutated-Stage III/IV Melanoma
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no…
- Trial name
- NCT06557291
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Novartis
Melanoma and Metastatic Colorectal Cancer
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase…
- Trial name
- NCT01436656
- Testing
- LGX818
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 107 people
- Sponsor
- Pfizer
Unresectable Metastatic Melanoma
Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System
The goal of this prospective, low-interventional study is to develop and optimize a highly sensitive and specific method for the detection of the BRAF V600E mutation in liquid biopsy samples from patients with unresectable…
- Trial name
- BRAF SENS (NCT07870265)
- Testing
- Novel CRISPR/Cas12a Electrochemical Bioassay, Reference Standard Molecular Diagnostics (NGS and ddPCR), Serial Peripheral Blood Sampling for Liquid Biopsy
- Where
- Czechia
- Volunteers
- 17 people
- Sponsor
- Masaryk Memorial Cancer Institute
Advanced Solid Tumor, BRAF V600 Mutation
Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
This is a Phase I, First-In-Human, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in adult patients with locally…
- Trial name
- NCT04190628
- Testing
- ABM-1310, Cobimetinib
- Where
- 8 sites in United States
- Volunteers
- 53 people
- Sponsor
- ABM Therapeutics Corporation
Solid Tumor
Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations
This is a single-centre, open-label Phase II study of the investigational drugs binimetinib and encorafenib that will be taken my mouth (orally) daily in adult patient with advanced and/or metastatic solid tumors for which no…
- Trial name
- BEAVER (NCT03839342)
- Testing
- Binimetinib, Encorafenib
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- University Health Network, Toronto
Melanoma
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection.
- Trial name
- COMBI-AD (NCT01682083)
- Testing
- Dabrafenib, Trametinib
- Where
- 168 sites in United States, Argentina and 23 more
- Volunteers
- 870 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Melanoma, Cancer
Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies
The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of…
- Trial name
- NCT02441465
- Testing
- Vemurafenib, 14C-Labeled Vemurafenib
- Where
- Hungary
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Melanoma, Non Small Cell Lung Cancer
Dabrafenib and/or Trametinib Rollover Study
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have…
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers
- Trial name
- NCT03340506
- Testing
- dabrafenib, trametinib
- Where
- 38 sites in United States, Argentina and 13 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Hairy Cell Leukemia
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
Background: Hairy cell leukemia (HCL) does not usually respond to chemotherapy. Most people with HCL have a BRAF gene mutation. This can increase the growth of cancer cells. Vemurafenib has been tested to treat these people.
- Trial name
- NCT04324112
- Testing
- binimetinib, Encorafenib
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
Malignant Melanoma
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
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
- Trial name
- COMBI-APlus (NCT03551626)
- Testing
- Dabrafenib, Trametinib
- Where
- 100 sites in Argentina, Australia and 21 more
- Volunteers
- 552 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, BRAF Gene Mutation
Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and…
- Conditions
- Advanced Solid Tumor, BRAF Gene Mutation, BRAF Gene Alteration, MEK Mutation
- Trial name
- NCT04488003
- Testing
- Ulixertinib, Physician's Choice
- Where
- 22 sites in United States
- Volunteers
- 104 people
- Sponsor
- BioMed Valley Discoveries, Inc
Metastatic Colorectal Cancer, BRAF V600 Mutation
A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Previous studies have shown that BRAFV600E mutant mCRC patients have a shorter survival time than BRAF wild type mCRC patients. For Chinese patients, however, it remains unclear about the BRAF gene mutation rate, diagnosis…
- Trial name
- NCT06749015
- Testing
- Non interventional study
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Melanoma
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
This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma…
- Trial name
- NCT04666272
- Testing
- dabrafenib, trametinib
- Where
- 8 sites in China
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Melanoma, BRAF Gene Mutation
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a…
- Trial name
- NCT04903119
- Testing
- Nilotinib 100mg, Nilotinib 200mg, Nilotinib 300mg
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Rina Plattner
Solid Tumors (Phase 1)
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid…
- Trial name
- NCT07561554
- Testing
- HSK42360-Na
- Where
- 2 sites in China
- Volunteers
- 159 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Metastatic Melanoma, BRAF V600 Mutation Positive
UK ENcorafenib and BInimetinib Real-world Study in Melanoma
This is a prospective longitudinal multi-centre observational study conducted in the United Kingdom, in patients with metastatic cutaneous BRAF V600 mutation-positive melanoma assigned to receive encorafenib and binimetinib.
- Trial name
- UK-EnBiRiM (NCT07022457)
- Testing
- Encorafenib + Binimetinib
- Where
- 7 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Pierre Fabre Ltd
Melanoma
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
- Trial name
- NCT01673854
- Testing
- Ipilimumab, Vemurafenib
- Where
- 14 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bristol-Myers Squibb