Clinical trials: BRAF V600E Mutation
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
BRAF V600E-mutant Metastatic Colorectal Cancer
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received…
- Trial name
- ANCHOR-CRC (NCT03693170)
- Testing
- encorafenib, Binimetinib, Cetuximab
- Where
- 45 sites in United States, Austria and 7 more
- Volunteers
- 95 people
- Sponsor
- Pierre Fabre Medicament
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
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
Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Melanoma
Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma
This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF…
- Conditions
- Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Trial name
- NCT04527549
- Testing
- Dabrafenib mesylate, Hydroxychloroquine, Trametinib dimethyl sulfoxide
- Where
- 199 sites in United States
- Volunteers
- 5 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
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
BRAF V600E-mutant Metastatic Colorectal Cancer
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in…
- Trial name
- BEACON CRC (NCT02928224)
- Testing
- Encorafenib, Binimetinib, Cetuximab
- Where
- 418 sites in United States, Argentina and 25 more
- Volunteers
- 702 people
- Sponsor
- Pfizer
BRAF V600E Negative, KRAS Gene Mutation Negative
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or…
- Conditions
- BRAF V600E Negative, KRAS Gene Mutation Negative, Locally Advanced Unresectable Colorectal Adenocarcinoma, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT04117945
- Testing
- Cetuximab, Irinotecan, Panitumumab
- Where
- 15 sites in United States
- Volunteers
- 22 people
- Sponsor
- Academic and Community Cancer Research United
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
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
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
Papillary Thyroid Carcinoma
Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436
Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no longer respond to radioactive iodine therapy…
- Trial name
- NCT01534897
- Testing
- GSK2118436
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
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
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
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