Clinical trials: BRAF V600E Mutation Positive
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after…
- Conditions
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Trial name
- NCT04310397
- Testing
- Dabrafenib, Spartalizumab, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
Melanoma
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma.
- Trial name
- NCT01245062
- Testing
- GSK1120212, Chemotherapy
- Where
- 112 sites in United States, Argentina and 17 more
- Volunteers
- 322 people
- Sponsor
- GlaxoSmithKline
Cancer
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the…
- Trial name
- NCT01750918
- Testing
- Dabrafenib, Trametinib, Panitumumab
- Where
- 20 sites in United States, Belgium and 6 more
- Volunteers
- 166 people
- Sponsor
- Novartis Pharmaceuticals
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 Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or…
- Trial name
- coBRIM (NCT01689519)
- Testing
- Vemurafenib, Cobimetinib
- Where
- 156 sites in United States, Australia and 17 more
- Volunteers
- 495 people
- Sponsor
- Hoffmann-La Roche
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 V600E Mutation Present, Papillary Craniopharyngioma
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma.
- Trial name
- NCT03224767
- Testing
- Vemurafenib, Cobimetinib, Laboratory Biomarker Analysis
- Where
- 106 sites in United States
- Volunteers
- 24 people
- Sponsor
- Alliance for Clinical Trials in Oncology
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
Cancer
Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects…
- Trial name
- NCT01336634
- Testing
- Dabrafenib, Trametinib
- Where
- 50 sites in United States, France and 9 more
- Volunteers
- 177 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
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
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
BRAF V600E Mutation
Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease
Erdheim-Chester Diseases (ECD) is a very rare non-Langerhans cell histiocytosis of unknown origin and pathogenesis. It has been reported mainly in adult males over the age of 40 years, although cases have been reported in females…
- Trial name
- NCT02281760
- Testing
- Dabrafenib Mesylate, Trametinib Dimethyl Sulfoxide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Thyroid Carcinoma, Thyroid Cancer
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors.
- Conditions
- Thyroid Carcinoma, Thyroid Cancer, Thyroid Cancer, Follicular, Thyroid Cancer (Follicular Cell)
- Trial name
- NCT04462471
- Testing
- I-124 PET/CT lesion dosimetry, Vemurafenib, Copanlisib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
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