Clinical trials: BRAF V600 Mutation
Cancer, Melanoma
Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
This was a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or metastatic Acral lentiginous or cutaneous…
- Trial name
- NCT02083354
- Testing
- Dabrafenib, Trametinib
- Where
- 13 sites in China, Hong Kong and 3 more
- Volunteers
- 77 people
- Sponsor
- Novartis Pharmaceuticals
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
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, 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
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
NSCLC
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation
- Trial name
- NCT05065398
- Testing
- HLX208
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Henlius Biotech
Cancer
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors
BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in…
- Trial name
- NCT01582997
- Testing
- GSK2118436
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Small Cell Lung Carcinoma
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
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of eligible patients diagnosed with BRAF V600E/K activating mutation-positive…
- Trial name
- NCT04507919
- Testing
- Dabrafenib, Trametininb
- Sponsor
- Novartis Pharmaceuticals
BRAF V600 Colorectal Cancer
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
- Trial name
- NCT04294160
- Testing
- Dabrafenib, LTT462, Trametinib
- Where
- 18 sites in United States, Australia and 8 more
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
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
Metastatic Melanoma
A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma
This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases.
- Trial name
- NCT02768207
- Testing
- Cobimetinib, Vemurafenib
- Where
- 14 sites in Belgium, Poland
- Volunteers
- 40 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
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
Metastatic Non-small Cell Lung Cancer, BRAF V600 Mutation
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation.
- Trial name
- NCT05546905
- Where
- 39 sites in France, Germany and 3 more
- Volunteers
- 206 people
- Sponsor
- Pierre Fabre Medicament
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
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
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
Solid Tumor
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.
- Trial name
- NCT03781219
- Testing
- HL-085, Vemurafenib
- Where
- 4 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Kechow Pharma, Inc.