Clinical Trials

Numerous clinical trials evaluate encorafenib (LGX818) across BRAF V600-mutated malignancies, including metastatic melanoma, colorectal adenocarcinoma, relapsed or refractory multiple myeloma, and advanced central nervous system tumors such as glioblastoma and high-grade glioma. Ranging from Phase 1 dose-escalation to randomized Phase 3 combination studies, these trials encompass active, recruiting, and completed statuses. Sponsored by pharmaceutical entities like Pfizer and Array BioPharma alongside academic institutions and the National Cancer Institute, this research focuses on overcoming therapeutic resistance and improving clinical outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05725200 RECRUITING
Metastatic Colorectal Cancer
Oslo University Hospital
 2022-09-27 PHASE2
NCT05710406 ACTIVE_NOT_RECRUITING
Colon Adenocarcinoma; Microsatellite Stable Colon Carcinoma; Stage IIB Colon Cancer AJCC v8; Stage IIC Colon Cancer AJCC v8; Stage III Colon Cancer AJCC v8
Alliance for Clinical Trials in Oncology
 2023-08-16 PHASE2; PHASE3
NCT07092410 WITHDRAWN
Melanoma BRAF V600E/K Mutated
SRH Wald-Klinikum Gera GmbH
 2025-08 PHASE4
NCT07789210 RECRUITING
Colorectal Cancer; BRAF V600E Mutation Positive; Encorafenib; Cetuximab N01
Zhejiang University
 2026-06-30 PHASE2
NCT05203172 RECRUITING
Solid Tumors
Pfizer
 2022-07-05 PHASE4
NCT06207656 RECRUITING
Colorectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
 2024-04-16 PHASE2
NCT04903119 RECRUITING
Metastatic Melanoma; BRAF Gene Mutation
Rina Plattner
 2022-06-01 PHASE1
NCT05985954 RECRUITING
Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
 2024-01-18 PHASE1
NCT07178717 NOT_YET_RECRUITING
Colo-rectal Cancer
Vall d'Hebron Institute of Oncology
 2025-10 PHASE2
NCT06194929 RECRUITING
Cutaneous Melanoma; Brain Metastases
University of Utah
 2024-03-20 PHASE1; PHASE2
NCT06887088 RECRUITING
Melanoma BRAF V600E/K Mutated; Melanoma and Brain Metastases
Grupo Español Multidisciplinar de Melanoma
 2025-05-29 PHASE2
NCT04017650 ACTIVE_NOT_RECRUITING
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; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Rectal Adenocarcinoma
M.D. Anderson Cancer Center
 2019-06-14 PHASE1; PHASE2
NCT04061980 ACTIVE_NOT_RECRUITING
BRAF NP_004324.2:p.V600M; BRAF V600E Mutation Present; Metastatic Thyroid Gland Carcinoma; Refractory Thyroid Gland Carcinoma; Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8; Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8; Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
Providence Health & Services
 2020-10-30 PHASE2
NCT02910700 ACTIVE_NOT_RECRUITING
Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Stage III Cutaneous Melanoma AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Melanoma
M.D. Anderson Cancer Center
 2016-12-09 PHASE2
NCT07318389 NOT_YET_RECRUITING
Dynamic Tumor Resistance; Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
 2026-06-10 EARLY_PHASE1
NCT04511013 RECRUITING
Acral Lentiginous Melanoma; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Cutaneous Melanoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Metastatic Mucosal Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8
SWOG Cancer Research Network
 2021-01-06 PHASE2
NCT05615818 RECRUITING
Biliary Tract Neoplasms
UNICANCER
 2024-07-18 PHASE3
NCT06411600 RECRUITING
Metastatic Colorectal Cancer
Vall d'Hebron Institute of Oncology
 2024-05-17 PHASE2
NCT05270044 ACTIVE_NOT_RECRUITING
Melanoma
Pierre Fabre Medicament
 2022-05-02 PHASE3
NCT05026983 RECRUITING
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8
M.D. Anderson Cancer Center
 2021-12-27 PHASE2
NCT06102902 SUSPENDED
Metastatic Colorectal Adenocarcinoma; Recurrent Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage IV Colorectal Cancer AJCC v8
National Cancer Institute (NCI)
 2024-06-05 PHASE1
NCT05706779 RECRUITING
Colorectal Cancer; BRAF V600E Mutation Positive
Federation Francophone de Cancerologie Digestive
 2023-02-13 PHASE2
NCT03803553 RECRUITING
Metastatic Colon Cancer; Stage III Colon Cancer
Massachusetts General Hospital
 2020-04-16 PHASE3
NCT03839342 ACTIVE_NOT_RECRUITING
Solid Tumor
University Health Network, Toronto
 2019-06-07 PHASE2
NCT04657991 ACTIVE_NOT_RECRUITING
Melanoma
Pfizer
 2021-01-15 PHASE3
NCT06578559 ACTIVE_NOT_RECRUITING
Colorectal Cancer
Gruppo Oncologico del Nord-Ovest
 2024-07-23 PHASE2
NCT04741997 RECRUITING
Melanoma Stage III; Melanoma Stage IV; BRAF V600 Mutation
H. Lee Moffitt Cancer Center and Research Institute
 2021-05-24 EARLY_PHASE1
NCT05217446 ACTIVE_NOT_RECRUITING
Metastatic Colorectal Cancer
Pfizer
 2022-07-11 PHASE2
NCT04324112 ACTIVE_NOT_RECRUITING
Hairy Cell Leukemia
National Cancer Institute (NCI)
 2020-10-28 PHASE2
NCT04074096 ACTIVE_NOT_RECRUITING
Malignant Melanoma; BRAF V600 Mutation; Brain Metastases
UNICANCER
 2022-09-05 PHASE2
NCT05308446 ACTIVE_NOT_RECRUITING
Metastatic Colon Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Rectal Adenocarcinoma
National Cancer Institute (NCI)
 2022-07-19 PHASE2
NCT05926960 TERMINATED
Melanoma
Pfizer
 2023-06-13 PHASE2
NCT05767879 UNKNOWN
Melanoma Stage III; In-Transit Metastasis of Cutaneous Melanoma
Leiden University Medical Center
 2022-01-01 PHASE2
NCT06640166 RECRUITING
Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumor; Colorectal Adenocarcinoma; Colorectal Cancer (CRC); Colorectal Cancer; Colon Cancer; Colon Adenocarcinoma; Colon Carcinoma; Colon Neoplasm
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2024-06-03 PHASE2
NCT05576896 TERMINATED
Stage IV Colorectal Cancer Positive for BRAF V600E Mutation; Colorectal Cancer; Colorectal Cancer Stage IV
Northwestern University
 2022-10-10 PHASE2
NCT05039177 COMPLETED
Metastatic Colorectal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma
Erasca, Inc.
 2021-09-20 PHASE1; PHASE2
NCT05304546 COMPLETED
Malignant Melanoma; Metastatic Melanoma; Immunotherapy; BRAF V600E; Malignant Melanoma Stage IV
Dr. Ronnie Shapira
 2023-09-05 PHASE2
NCT04526782 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; BRAF V600E
Intergroupe Francophone de Cancerologie Thoracique
 2021-01-19 PHASE2
NCT04607421 ACTIVE_NOT_RECRUITING
Neoplasms
Pfizer
 2020-12-21 PHASE3
NCT03543969 ACTIVE_NOT_RECRUITING
Melanoma (Skin); Skin Cancer; Skin Melanoma; Skin Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2018-06-14 EARLY_PHASE1
NCT04720768 UNKNOWN
Melanoma; Metastasis
Peter MacCallum Cancer Centre, Australia
 2020-06-04 PHASE1; PHASE2
NCT05510895 COMPLETED
Colorectal Cancer; Colon Cancer; BRAF V600E; BRAF V600 Mutation; Localized Cancer
AIO-Studien-gGmbH
 2022-09-01 PHASE2
NCT05743036 TERMINATED
Metastatic Colorectal Cancer
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
 2023-02-27 PHASE1
NCT04800822 TERMINATED
Solid Tumor
Pfizer
 2021-03-17 PHASE1
NCT05097599 TERMINATED
Cancer; Advanced Solid Tumor
Strata Oncology
 2022-04-29 PHASE2
NCT04221438 TERMINATED
Melanoma of Unknown Primary; Metastatic Malignant Neoplasm in Lymph Node; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Recurrent Cutaneous Melanoma
ECOG-ACRIN Cancer Research Group
 2021-09-22 PHASE2
NCT03563729 RECRUITING
Malignant Melanoma
Inge Marie Svane
 2018-06-06 PHASE2
NCT05195632 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Pierre Fabre Medicament
 2022-06-02 PHASE2
NCT05004350 COMPLETED
BRAF V600E; Metastatic Colorectal Cancer
Pierre Fabre Medicament
 2021-09-14 PHASE2
NCT04390243 TERMINATED
Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
Academic and Community Cancer Research United
 2020-11-16 PHASE2
NCT03235245 ACTIVE_NOT_RECRUITING
Unresectable Stage III Melanoma; Stage IV Melanoma
European Organisation for Research and Treatment of Cancer - EORTC
 2018-10-30 PHASE2
NCT03843775 COMPLETED
Advanced BRAF Mutant Cancers
Memorial Sloan Kettering Cancer Center
 2019-02-14 PHASE1; PHASE2
NCT05097378 UNKNOWN
Melanoma; Cancer
CCTU- Cancer Theme
 2022-01-01 PHASE2
NCT04585815 TERMINATED
Carcinoma, Non-Small-Cell Lung
Pfizer
 2020-11-10 PHASE1; PHASE2
NCT04759846 WITHDRAWN
BRAF V600 Mutation; Unresectable Melanoma; Metastatic Melanoma; Hepatic Impairment
Pierre Fabre Medicament
 2021-01-21 PHASE1
NCT02834364 COMPLETED
Relapsed or Refractory Multiple Myeloma; Patients With BRAFV600 E or BRAFV600K Mutation
University of Heidelberg Medical Center
 2016-06 PHASE2
NCT02675946 UNKNOWN
Solid Tumors; GI Cancer
Curegenix Inc.
 2016-02 PHASE1
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
 2021-09-23
NCT03898908 COMPLETED
Metastatic Melanoma; Brain Metastases
Grupo Español Multidisciplinar de Melanoma
 2019-07-18 PHASE2
NCT05446142 COMPLETED
Healthy
Pfizer
 2022-07-01 PHASE1
NCT03915951 COMPLETED
Non-small Cell Lung Cancer
Pfizer
 2019-06-04 PHASE2
NCT03878719 TERMINATED
Melanoma
Pfizer
 2020-08-03 PHASE1
NCT04655157 TERMINATED
Melanoma
Jason J. Luke, MD
 2021-05-28 PHASE1; PHASE2
NCT04044430 TERMINATED
Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer; Stage III Colorectal Cancer; Stage III Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Colorectal Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Colorectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Colorectal Cancer; Stage IIIC Rectal Cancer; Stage IV Colon Cancer; Stage IV Colorectal Cancer; Stage IV Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Colorectal Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Colorectal Cancer; Stage IVB Rectal Cancer; Stage IVC Colon Cancer; Stage IVC Colorectal Cancer; Stage IVC Rectal Cancer
University of California, San Francisco
 2020-08-31 PHASE1
NCT03864042 COMPLETED
Advanced Solid Tumors; Metastatic Melanoma
Pfizer
 2018-01-02 PHASE1
NCT05003622 COMPLETED
BRAF V600E Unresectable or Metastatic Melanoma; BRAF V600E Metastatic NSCLC; Melanoma
Pierre Fabre Medicament
 2021-09-27 PHASE1
NCT03973918 TERMINATED
High Grade Glioma; BRAF V600E; BRAF V600K; Anaplastic Astrocytoma; Anaplastic Pleomorphic Xanthoastrocytoma; Gliosarcoma; Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2019-07-29 PHASE2
NCT03911869 TERMINATED
Brain Metastases
Pfizer
 2019-04-30 PHASE2
NCT02857270 COMPLETED
Advanced Cancer; Metastatic Melanoma; Metastatic Non-small Cell Lung Cancer; Colorectal Cancer
Eli Lilly and Company
 2016-09-29 PHASE1
NCT02902042 COMPLETED
Malignant Melanoma
Prof. Dr. med. Dirk Schadendorf
 2018-04-24 PHASE1; PHASE2
NCT03693170 COMPLETED
BRAF V600E-mutant Metastatic Colorectal Cancer
Pierre Fabre Medicament
 2019-01-17 PHASE2
NCT02928224 COMPLETED
BRAF V600E-mutant Metastatic Colorectal Cancer
Pfizer
 2016-10-13 PHASE3
NCT02834364 Completed
Relapsed or Refractory Multiple Myeloma|Patients With BRAFV600 E or BRAFV600K Mutation
University of Heidelberg Medical Center|Array BioPharma|German Cancer Research Center|Coordinating Centre for Clinical Trials Heidelberg|University Hospital Heidelberg
 2016-06 Phase 2
NCT02278133 Completed
Metastatic Colorectal Cancer
Array BioPharma
 2014-12 Phase 1|Phase 2
NCT01909453 Active not recruiting
Melanoma
Pfizer
 2013-09-16 Phase 3
NCT01719380 Completed
Colorectal Cancer
Pfizer
 2012-11-23 Phase 2
NCT01436656 Completed
Melanoma and Metastatic Colorectal Cancer
Pfizer
 2011-09-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2023-02-21)

Check the LGX818 (Encorafenib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Encorafenib functions as a potent, selective ATP-competitive inhibitor of BRAF kinase, selectively binding to the BRAF V600E mutant protein to disrupt the downstream MAPK/ERK signaling cascade and suppress tumor cell proliferation while inducing apoptosis. This targeted inhibition of oncogenic signaling accounts for its clinical efficacy in suppressing tumor growth and disease progression in BRAF V600-mutated malignancies, including metastatic melanoma and colorectal cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.