Clinical trials: BRAF V600 Mutation
Solid Tumor, Adult, Non-small Cell Lung Cancer
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma
- Trial name
- NCT04913285
- Testing
- KIN-2787, KIN-2787 and binimetinib
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 400 people
- Sponsor
- Pierre Fabre Medicament
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
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
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
Melanoma (Skin), Metastatic Melanoma
A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients
1. Background The purpose of this study is to describe the profile of patients with BRAF-mutated melanoma treated with BRAF/MEK inhibitors combination and using the Tavie Skin application.
- Conditions
- Melanoma (Skin), Metastatic Melanoma, BRAF V600 Mutation
- Trial name
- TavieSkin (NCT04911998)
- Where
- Portugal
- Volunteers
- 400 people
- Sponsor
- Pierre Fabre Medicament
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.
Diffuse Astrocytoma, Anaplastic Astrocytoma
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
The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high…
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT02684058
- Testing
- Dabrafenib, trametinib, Carboplatin
- Where
- 57 sites in United States, Argentina and 18 more
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
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
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
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
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.
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
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
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
Advanced Melanoma
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
- Trial name
- NCT05114603
- Testing
- HLX208
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Henlius Biotech
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, 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