Clinical trials: BRAF V600E Mutation
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
Metastatic Colorectal Cancer
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant…
- Trial name
- NCT05743036
- Testing
- ZN-c3, Encorafenib, Cetuximab
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 44 people
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
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
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
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
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.
Advanced Solid Tumor (Phase 1), Pancreas Adenocarcinoma
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic…
- Conditions
- Advanced Solid Tumor (Phase 1), Pancreas Adenocarcinoma, Non-small Cell Lung Cancer, Malignant Melanoma (Cutaneous)
- Trial name
- NCT06208124
- Testing
- IMM-6-415
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Immuneering Corporation
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
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
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
Melanoma, Malignant Melanoma
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
This study will evaluate the efficacy and safety of T3011 in combination with Cobimetinib in patients with advanced melanoma.
- Trial name
- NCT05756556
- Testing
- T3011 + Cobimetinib
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- ImmVira Pharma Co. Ltd
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.
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
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
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
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
Melanoma
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: is advanced or metastatic (spread to other parts of…
- Trial name
- NCT04657991
- Testing
- Encorafenib, Binimetinib, Pembrolizumab
- Where
- 151 sites in United States, Argentina and 25 more
- Volunteers
- 257 people
- Sponsor
- Pfizer
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
Metastatic Colorectal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma
A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies
To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies.
- Trial name
- HERKULES-3 (NCT05039177)
- Testing
- ERAS-007, Encorafenib, Cetuximab
- Where
- 14 sites in United States
- Volunteers
- 101 people
- Sponsor
- Erasca, Inc.