Clinical trials: BRAF NP_004324.2:p.V600E
Solid Tumor
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation
- Trial name
- NCT05528406
- Testing
- HLX208
- Volunteers
- 30 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Colorectal Cancer
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the…
- Trial name
- SEAMARK (NCT05217446)
- Testing
- Encorafenib, Cetuximab, Pembrolizumab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 108 people
- Sponsor
- Pfizer
Melanoma
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk…
- Trial name
- LEAD Melanoma (NCT04961619)
- Testing
- dabrafenib, trametinib
- Where
- 9 sites in Turkey (Türkiye)
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Melanoma
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma.
- Trial name
- NCT01107418
- Testing
- RO5185426
- Where
- 13 sites in United States, Australia
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Solid Tumours
Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma
This is an open-label, multi-center, dose-finding Phase 1 study that will enroll subjects at least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations.
- Trial name
- NCT01767454
- Testing
- Dabrafenib, Trametinib, Ipilimumab
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Melanoma
Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma
This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable…
- Trial name
- NCT02416232
- Testing
- Trametinib, Dabrafenib
- Where
- 46 sites in France
- Sponsor
- GlaxoSmithKline
Metastatic Colorectal Cancer, mCRC
The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).
- Trial name
- NCT05127759
- Testing
- HLX208
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Shanghai Henlius Biotech
Non-Small Cell Lung Cancer
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple…
- Trial name
- ORCHARD (NCT03944772)
- Testing
- Osimertinib, Savolitinib, Gefitinib
- Where
- 47 sites in United States, Denmark and 7 more
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
Colorectal Cancer Metastatic
Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
This is a multicenter, randomized, open-label, Phase 3 study
- Trial name
- NCT06008119
- Testing
- Tunlametinib plus Vemurafenib, Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Shanghai Kechow Pharma, Inc.
Neoplasms
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: has spread to other parts of the…
- Trial name
- NCT04607421
- Testing
- Encorafenib, Cetuximab, Oxaliplatin
- Where
- 272 sites in United States, Argentina and 27 more
- Volunteers
- 841 people
- Sponsor
- Pfizer
BRAF V600E Unresectable or Metastatic Melanoma, BRAF V600E Metastatic NSCLC
Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors
This is a phase 1, multicenter, open-label, single-arm study to investigate the safety and tolerability of encorafenib 300 mg once daily (QD) monotherapy in adult Chinese participants with B-RAF Proto-oncogene, Serine/threonine…
- Conditions
- BRAF V600E Unresectable or Metastatic Melanoma, BRAF V600E Metastatic NSCLC, Melanoma
- Trial name
- OCEANI (NCT05003622)
- Testing
- Encorafenib
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Pierre Fabre Medicament
Cancer Harboring BRAF Alterations, HGG
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive…
- Conditions
- Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
- Trial name
- NCT05503797
- Testing
- Plixorafenib
- Where
- 70 sites in United States, Australia and 10 more
- Volunteers
- 254 people
- Sponsor
- Fore Biotherapeutics
Melanoma
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
- Trial name
- COMBI-v (NCT01597908)
- Testing
- Dabrafenib, Vemurafenib, Trametinib
- Where
- 205 sites in United States, Argentina and 26 more
- Volunteers
- 704 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy).
- Trial name
- NCT01584648
- Testing
- Dabrafenib, Trametinib
- Where
- 121 sites in United States, Argentina and 12 more
- Volunteers
- 423 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
This was a single-arm, open label, multicenter phase II, study of dabrafenib in combination with trametinib in Chinese participants with BRAF V600E mutation positive, stage IV NSCLC (American joint committee on cancer staging 8th…
- Trial name
- NCT04452877
- Testing
- Dabrafenib, Trametinib
- Where
- 8 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma and Brain Metastases
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain.
- Trial name
- NCT02039947
- Testing
- Dabrafenib, Trametinib
- Where
- 47 sites in United States, Australia and 5 more
- Volunteers
- 127 people
- 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
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study.
- Trial name
- NCT04585815
- Testing
- Sasanlimab Prefilled syringe, Encorafenib, Binimetinib
- Where
- 55 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Pfizer
Non-Small-Cell Lung Cancer
Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC
This is an open-label, multicenter, non-randomized, single arm, phase II study to assess efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with any line, stage IV NSCLC harboring a confirmed…
- Trial name
- NCT02672358
- Testing
- Dabrafenib, Trametinib
- Sponsor
- Novartis Pharmaceuticals