Clinical trials: BRAF V600 Mutation
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
Cancer
Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of…
- Trial name
- NCT02082665
- Testing
- Rosuvastatin10 mg tablet, Midazolam 3 mg syrup, Dabrafenib 75 mg capsule
- Where
- 4 sites in United States, Spain
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Melanoma, BRAF V600 Mutation
Relative Bioavailability of 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
- NCT05103891
- Testing
- Binimetinib Oral Tablet
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
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
V600-mutated BRAF Unresectable Melanoma, V600-mutated BRAF Metastatic Melanoma
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels.
- Conditions
- V600-mutated BRAF Unresectable Melanoma, V600-mutated BRAF Metastatic Melanoma, Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
- Trial name
- NCT01826448
- Testing
- PLX3397, vemurafenib
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 13 people
- Sponsor
- Daiichi Sankyo
Solid Tumors
JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
This is a Phase 1 study of JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
- Trial name
- NCT04418167
- Testing
- JSI-1187, Dabrafenib
- Where
- 7 sites in United States
- Volunteers
- 71 people
- Sponsor
- JS InnoPharm, LLC
Melanoma
Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4…
- Trial name
- NCT01400451
- Testing
- Ipilimumab (BMS-734016), Vemurafenib
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Bristol-Myers Squibb
Solid Tumors
Phase I Study of HSK42360 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 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid…
- Trial name
- NCT06536400
- Testing
- HSK42360
- Where
- 13 sites in China
- Volunteers
- 316 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Neoplasms
A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid tumors.
- Trial name
- NCT01143753
- Testing
- RO5212054
- Where
- 5 sites in Australia, Denmark and 1 more
- Volunteers
- 45 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
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
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
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, 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
Multiple Myeloma, Neoplasms
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and…
- Trial name
- NCT01524978
- Testing
- cetuximab, vemurafenib
- Where
- 34 sites in United States, China and 4 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
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
Neoplasms, Brain
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors.
- Trial name
- NCT01677741
- Testing
- Dabrafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 85 people
- Sponsor
- Novartis Pharmaceuticals
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
Multiple Myeloma, Neoplasms
A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)
This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib).
- Trial name
- NCT01804140
- Where
- 20 sites in United States
- Volunteers
- 662 people
- Sponsor
- Genentech, Inc.
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