Encorafenib

Generic Name: Encorafenib

Brand Names: Braftovi

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₇ClFN_₇O_₄S

CAS Number: 1269440-17-6

Unique Ingredient Identifier: 8L7891MRB6

Background: Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Encorafenib inhibits BRAF gene, which encodes for B-raf protein, which is a proto-oncogene involved in various genetic mutations. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most fr...

Indication: Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation and metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. It is also indicated in combination with cetuximab for the treatment of adult patients with metastatic colorecta...

Associated Conditions: Metastatic Colorectal Cancer (CRC), Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Unresectable Melanoma

Associated Therapies: -

Clinical Trials

Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL

Phase 2

Recruiting

Conditions: Hairy Cell Leukemia

Interventions: Drug: binimetinib
Drug: Encorafenib

First Posted Date: 2020-03-27

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT04324112

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement

Phase 2

Active, not recruiting

Conditions: Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
Recurrent Cutaneous Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Metastatic Malignant Neoplasm in Lymph Node

Interventions: Drug: Binimetinib
Procedure: Computed Tomography
Procedure: Conventional Surgery
Drug: Encorafenib
Other: Fluorothymidine F-18
Procedure: Positron Emission Tomography

First Posted Date: 2020-01-09

Last Posted Date: 2024-12-20

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 3

Registration Number: NCT04221438

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

and more 7 locations

Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: BRAF V600E Mutation Present
Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8
Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
Metastatic Thyroid Gland Carcinoma
Refractory Thyroid Gland Carcinoma
Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
BRAF NP_004324.2:p.V600M

Interventions: Drug: Binimetinib
Drug: Encorafenib
Biological: Nivolumab

First Posted Date: 2019-08-20

Last Posted Date: 2024-11-18

Lead Sponsor: Providence Health & Services

Target Recruit Count: 24

Registration Number: NCT04061980

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Phase 1

Terminated

Conditions: Metastatic Colon Adenocarcinoma
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIC Colon Cancer
Stage IIIC Colorectal Cancer
Stage IIIC Rectal Cancer
Stage IV Colon Cancer
Stage IIIA Colorectal Cancer
Stage IIIB Rectal Cancer

Interventions: Drug: Binimetinib
Drug: Encorafenib
Biological: Nivolumab
Other: Questionnaire Administration

First Posted Date: 2019-08-05

Last Posted Date: 2023-01-09

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 2

Registration Number: NCT04044430

Locations: 🇺🇸
Univeristy of California, San Francisco, San Francisco, California, United States
🇺🇸
Kaiser Permanente Northern California, San Francisco, California, United States

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Recruiting

Conditions: Melanoma Stage IV
Melanoma Stage III

First Posted Date: 2019-08-05

Last Posted Date: 2021-01-19

Lead Sponsor: Pierre Fabre Pharma GmbH

Target Recruit Count: 750

Registration Number: NCT04045691

Locations: 🇩🇪
45, Ahaus, Germany
🇦🇹
53, Wien, Austria
🇩🇪
49, Dresden, Germany

and more 56 locations

Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: BRAF NP_004324.2:p.V600E
Metastatic Colon Adenocarcinoma
Metastatic Microsatellite Stable Colorectal Carcinoma
Metastatic Rectal Adenocarcinoma
Progressive Disease
Recurrent Colorectal Carcinoma
Stage III Colorectal Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8

Interventions: Biological: Cetuximab
Drug: Encorafenib
Biological: Nivolumab

First Posted Date: 2019-07-12

Last Posted Date: 2024-10-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 38

Registration Number: NCT04017650

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG

Phase 2

Terminated

Conditions: High Grade Glioma
BRAF V600E
BRAF V600K
Anaplastic Astrocytoma
Anaplastic Pleomorphic Xanthoastrocytoma
Gliosarcoma
Glioblastoma

Interventions: Drug: Encorafenib
Drug: Binimetinib
Biological: Research Bloods
Biological: Tumor Tissue

First Posted Date: 2019-06-04

Last Posted Date: 2024-10-31

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 5

Registration Number: NCT03973918

Locations: 🇺🇸
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: encorafenib
Drug: binimetinib

First Posted Date: 2019-04-16

Last Posted Date: 2024-10-17

Lead Sponsor: Pfizer

Target Recruit Count: 98

Registration Number: NCT03915951

Locations: 🇺🇸
Ohio State CarePoint East, Columbus, Ohio, United States
🇺🇸
The Ohio State University James Cancer Hospital, Columbus, Ohio, United States
🇺🇸
Ohio State Eye and Ear Institute, Columbus, Ohio, United States

and more 114 locations

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Phase 2

Terminated

Conditions: Brain Metastases

Interventions: Drug: encorafenib
Drug: binimetinib

First Posted Date: 2019-04-11

Last Posted Date: 2023-05-31

Lead Sponsor: Pfizer

Target Recruit Count: 13

Registration Number: NCT03911869

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸
Rocky Mountain Lions Eye Institute (RMLEI), Aurora, Colorado, United States
🇦🇺
Crows Nest Eye Surgery, Crows Nest, New South Wales, Australia

and more 22 locations

Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma
Brain Metastases

Interventions: Drug: encorafenib
Drug: binimetinib
Radiation: Whole brain radiation therapy
Radiation: Radiosurgery/stereotactic radiosurgery

First Posted Date: 2019-04-02

Last Posted Date: 2023-07-18

Lead Sponsor: Grupo Español Multidisciplinar de Melanoma

Target Recruit Count: 48

Registration Number: NCT03898908

Locations: 🇪🇸
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
🇪🇸
Complejo Hospitalario Universitario Insular de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain
🇪🇸
Hospital Clínico San Carlos, Madrid, Spain

and more 18 locations

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