Clinical trials: BRAF V600E Mutation
Solid Tumor
HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
- Trial name
- NCT04965220
- Testing
- HLX 208
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Shanghai Henlius Biotech
Melanoma Metastatic, Melanoma of Skin
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Why the research is needed: Researchers are looking for a better way to treat melanoma that has spread or cannot be removed surgically.
- Conditions
- Melanoma Metastatic, Melanoma of Skin, Melanoma BRAF V600E/K Mutated, Melanoma Recurrent
- Trial name
- NCT06784648
- Testing
- pembrolizumab (KEYTRUDA®), BI-1607, Ipilimumab (YervoyTM, 50 mg/10 mL solution)
- Where
- 4 sites in Germany, Spain and 1 more
- Volunteers
- 35 people
- Sponsor
- BioInvent International AB
CRC
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
- Trial name
- NCT04984369
- Testing
- HLX208, Cetuximab Injection [Erbitux]
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech
Melanoma
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
The main purpose of this study is to Evaluate the Efficacy and Safety of the combination of HL-085 and Vemurafenib in Advanced Melanoma Patients with BRAF V600E/K Mutation. This study includes IIa and IIb phase.
- Trial name
- NCT05263453
- Testing
- HL-085, Vemurafenib
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Shanghai Kechow Pharma, Inc.
Non-small-cell Lung Cancer
Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study
This is a single-arm, open, multicenter phase II clinical study to evaluate the efficacy and safety of HL-085 capsules combined with Vemurafenib in the treatment of BRAF V600E mutated patients with unresectable locally advanced…
- Trial name
- NCT05900219
- Testing
- HL-085+Vemurafenib
- Volunteers
- 75 people
- Sponsor
- Shanghai Kechow Pharma, Inc.
Low-grade Glioma, Pediatric Low-grade Gliomas
FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration
An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring…
- Conditions
- Low-grade Glioma, Pediatric Low-grade Gliomas, pLGG With BRAF Alteration
- Trial name
- NCT07004075
- Testing
- Luvometinib, Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Melanoma and Brain Metastases
Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites
This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain.
- Trial name
- NCT01978236
- Testing
- Dabrafenib 150 mg, Trametinib 2.0 mg
- Where
- 3 sites in United States, Australia
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Malignant Melanoma
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma.
- Trial name
- NCT01006980
- Testing
- Vemurafenib, Dacarbazine
- Where
- 111 sites in United States, Australia and 10 more
- Volunteers
- 675 people
- Sponsor
- Hoffmann-La Roche
Melanoma
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or…
- Trial name
- COLUMBUS (NCT01909453)
- Testing
- LGX818, MEK162, vemurafenib
- Where
- 282 sites in United States, Argentina and 27 more
- Volunteers
- 921 people
- Sponsor
- Pfizer
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
Melanoma
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
This is a multicenter Phase 1b, open-label study to evaluate the pharmacokinetic, safety and efficacy of binimetinib and encorafenib co-administered to adolescent patients with BRAF V600-mutant advanced/metastatic melanoma.
- Trial name
- NCT03878719
- Testing
- binimetinib, encorafenib
- Where
- Italy
- Volunteers
- 1 people
- Sponsor
- Pfizer
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
Solid Tumours
Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)
This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation…
- Trial name
- NCT01928940
- Testing
- dabrafenib, trametinib
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Melanoma
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma.
- Trial name
- PORTSIDE (NCT05926960)
- Testing
- encorafenib, binimetinib, pembrolizumab
- Where
- 24 sites in Germany, Italy and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
BRAF V600E Mutation Positive, Metastatic Colorectal Cancer
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for…
- Trial name
- CAPSTAN CRC (NCT04317599)
- Testing
- Non interventional
- Where
- 34 sites in Austria, Belgium and 5 more
- Volunteers
- 274 people
- Sponsor
- Pierre Fabre Medicament
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a…
- Trial name
- NCT05868629
- Testing
- Non-investigational
- Where
- 8 sites in United States
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Differentiated Thyroid Cancer (DTC)
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the…
- Trial name
- NCT04940052
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 153 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard…
- Trial name
- COLUMBUS-AD (NCT05270044)
- Testing
- Encorafenib and Binimetinib
- Where
- 155 sites in Argentina, Australia and 21 more
- Volunteers
- 815 people
- Sponsor
- Pierre Fabre Medicament
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
Malignant Melanoma
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF…
- Trial name
- NCT01586195
- Testing
- Vemurafenib
- Where
- 15 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.