encorafenib

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of encorafenib.

1. Pfizer 3
2. Pierre Fabre Medicament 2

Trials

32 of 74 trials shown

1. Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

   Active, not recruiting Phase 2/3 Alliance for Clinical Trials in Oncology Started 2023Primary completion 2034-06 NCT05710406

   encorafenib FDA EUcetuximab FDA EU

   BRAF V600E mutation

   BRAF V600EColon Adenocarcinoma, Microsatellite Stable Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8

2. Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

   Active, not recruiting Phase 3 Pierre Fabre Medicament Started 2022Primary completion 2027-03 NCT05270044

   encorafenib FDA EUbinimetinib FDA EU

   Available tumour sample for central determination of the BRAF V600E/K mutation.

   BRAF V600EStatus may be outdated, last updated 2023-11-22Melanoma

3. A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

   Active, not recruiting Phase 3 Pfizer Started 2021Primary completion 2026-10 NCT04657991

   encorafenib FDA EUbinimetinib FDA EUpembrolizumab

   Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-…

   BRAF V600EMelanoma

4. A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

   Active, not recruiting Phase 3 Pfizer Started 2020Primary completion 2025-03 NCT04607421

   encorafenib FDA EUcetuximab FDA EUoxaliplatinirinotecanleucovorinfluorouracilcapecitabinebevacizumab

   Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation

   BRAF V600ENeoplasms

5. Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

   Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020Primary completion 2026-12 NCT03803553

   FOLFIRIleucovorinfluorouracilirinotecannivolumab FDA EUencorafenibbinimetinibcetuximabtrastuzumabpertuzumab

   Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of…

   MSI-H / dMMRMetastatic Colon Cancer, Stage III Colon Cancer

6. A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases

   Recruiting Phase 2 Zhejiang University Started 2026Primary completion 2029-12 NCT07789210

   encorafenib FDA EUcetuximab FDA EUmFOLFOX6

   PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;

   BRAF V600EColorectal Cancer, BRAF V600E Mutation Positive, Encorafenib, Cetuximab N01

7. A Study to Characterize Encorafenib Plus Cetuximab as Rechallenge Treatment for BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy With BRAF Inhibitors-based Combinations

   Not yet recruiting Phase 2 Vall d'Hebron Institute of Oncology Started 2025Primary completion 2028-02 NCT07178717

   bevacizumabencorafenib FDA EU

   Presence of confirmed BRAF V600E mutation.

   BRAF V600EColo-rectal Cancer

8. Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

   Recruiting Phase 2 Grupo Español Multidisciplinar de Melanoma Started 2025Primary completion 2028-01 NCT06887088

   encorafenib FDA EUbinimetinib FDA EUcemiplimab

   A documented mutation in BRAF-V600 in the tumor tissue.

   BRAF V600EMelanoma BRAF V600E/K Mutated, Melanoma and Brain Metastases

9. Combination Therapy for BRAF-V600E Metastatic CRCm

   Recruiting Phase 2 Vall d'Hebron Institute of Oncology Started 2024Primary completion 2027-05 NCT06411600

   encorafenib FDA EUcetuximab FDA EUbevacizumab

   Presence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center…

   BRAF V600EMetastatic Colorectal Cancer

10. Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

    Active, not recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2024Primary completion 2026-05 NCT06578559

    cetuximab FDA EUencorafenib FDA EU

    Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

    BRAF V600EMSI-H / dMMRColorectal Cancer

11. Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

    Recruiting Phase 1/2 University of Utah Started 2024Primary completion 2028-01 NCT06194929

    defactinibavutometinibencorafenib FDA EU

    Cohort B: BRAF V600E or BRAF V600K

    BRAF V600ECutaneous Melanoma, Brain Metastases

12. Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

    Recruiting Phase 2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Started 2024Primary completion 2025-12 NCT06640166

    encorafenib FDA EUcetuximab FDA EUFOLFIRI

    presence of BRAF V600E mutation in tumor tissue (primary CRC and/or related metastasis) as previously determined…

    BRAF V600EColorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumor, Colorectal Adenocarcinoma

13. Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer

    Recruiting Phase 2 Federation Francophone de Cancerologie Digestive Started 2023Primary completion 2026-12 NCT05706779

    encorafenib FDA EUcetuximab FDA EU

    …m (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan assessment.

    BRAF V600EColorectal Cancer, BRAF V600E Mutation Positive

14. Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

    Active, not recruiting Phase 2 CCTU- Cancer Theme Started 2023Primary completion 2026-01 NCT05097378

    encorafenib FDA EUbinimetinib FDA EUStandard Adjuvant Treatment

    AJCC 8th edition stage III (B/C/D), or extracranial oligometastatic stage IV BRAFV600 mutant melanoma, based on histological/cytological and radiological assessments for which…

    BRAF V600EMelanoma, Cancer

15. Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022Primary completion 2026-02 NCT05308446

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Participants must have BRAF\^V600E mutated colorectal cancer as tested in a Clinical Laboratory Improvement Act (CLIA)-certi…

    BRAF V600EMSI-H / dMMRMetastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

16. A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

    Active, not recruiting Phase 2 Pfizer Started 2022Primary completion 2026-06 NCT05217446

    encorafenib FDA EUcetuximab FDA EUpembrolizumab

    Locally confirmed BRAF V600E mutation in tumor tissue or blood

    BRAF V600EMSI-H / dMMRMetastatic Colorectal Cancer

17. Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Pierre Fabre Medicament Started 2022Primary completion 2024-05 NCT05195632

    encorafenib FDA EUbinimetinib FDA EU

    Presence of B-Raf Proto-Oncogene, Serine/Threonine Kinase (BRAF) V600E mutation in tumor tissue previously determined by a local assay at any time prior to scre…

    BRAF V600ENon-Small Cell Lung Cancer

18. Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

    Active, not recruiting Phase 2 UNICANCER Started 2022Primary completion 2026-05 NCT04074096

    binimetinib FDA EUencorafenib FDA EUpembrolizumab

    Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

    BRAF V600EMalignant Melanoma, BRAF V600 Mutation, Brain Metastases

19. ENCOrafenib With Binimetinib in bRAF NSCLC

    Active, not recruiting Phase 2 Intergroupe Francophone de Cancerologie Thoracique Started 2021Primary completion 2025-07 NCT04526782

    encorafenib FDA EUbinimetinib FDA EU

    Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay.

    BRAF V600ENon Small Cell Lung Cancer, BRAF V600E

20. Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2021Primary completion 2027-02 NCT05026983

    binimetinib FDA EUencorafenib FDA EU

    Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistoche…

    BRAF V600EClinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8

21. A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

    Recruiting Phase 2 SWOG Cancer Research Network Started 2021Primary completion 2027-06 NCT04511013

    binimetinib FDA EUencorafenib FDA EUipilimumabnivolumab

    Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified labo…

    BRAF V600EAcral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain

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

    Active, not recruiting Phase 2 Providence Health & Services Started 2020Primary completion 2027-12 NCT04061980

    binimetinib FDA EUencorafenib FDA EUnivolumab

    …cally (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC)

    BRAF V600EBRAF NP_004324.2:p.V600M, BRAF V600E Mutation Present, Metastatic Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma

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

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2026-05 NCT04324112

    binimetinib FDA EUencorafenib FDA EU

    Participants must have BRAF V600 mutation as confirmed from fresh bone marrow aspirate, peripheral blood sample, or lymph …

    BRAF V600EHairy Cell Leukemia

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

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2019Primary completion 2027-12 NCT04017650

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Confirmation of BRAFV600E tumor as detected by a CLIA-certified laboratory.

    BRAF V600EBRAF NP_004324.2:p.V600E, Metastatic Colon Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma

25. Melanoma Metastasized to the Brain and Steroids

    Recruiting Phase 2 Inge Marie Svane Started 2018Primary completion 2024-06 NCT03563729

    pembrolizumabipilimumabnivolumabencorafenib FDA EUbinimetinib FDA EUdabrafenib FDA EUtrametinib FDA EU

    For arm E specifically: Tumor cells must harbor BRAF mutation.

    BRAF V600EStatus may be outdated, last updated 2023-07-13Malignant Melanoma

26. Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

    Active, not recruiting Phase 2 European Organisation for Research and Treatment of Cancer - EORTC Started 2018Primary completion 2023-10 NCT03235245

    nivolumabipilimumabencorafenib FDA EUbinimetinib FDA EU

    …te Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

    BRAF V600EUnresectable Stage III Melanoma, Stage IV Melanoma

27. Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2016Primary completion 2027-12 NCT02910700

    binimetinib FDA EUdabrafenib FDA EUencorafenib FDA EUnivolumabtrametinib FDA EU

    … With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    BRAF V600EMetastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7

28. Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

    Recruiting Phase 1 M.D. Anderson Cancer Center Started 2024Primary completion 2028-03 NCT05985954

    cetuximab FDA EUulixertinibencorafenib FDA EU

    BRAF expansion Cohort: BRAF V600E mutation must be present

    BRAF V600EMetastatic Colorectal Cancer

29. Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2024Primary completion 2027-01 NCT06102902

    ZEN-3694cetuximab FDA EUencorafenib FDA EU

    …confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified labo…

    BRAF V600EMetastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8

30. Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

    Recruiting Phase 1 Rina Plattner Started 2022Primary completion 2028-07 NCT04903119

    Nilotinib 100mgNilotinib 200mgNilotinib 300mgNilotinib 400mgdabrafenib FDA EUtrametinib FDA EUencorafenib FDA EUbinimetinib FDA EU

    3.1.2 Patients must have a BRAF V600 mutation.

    BRAF V600EMetastatic Melanoma, BRAF Gene Mutation

31. Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

    Recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2021Primary completion 2027-04 NCT04741997

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th e…

    BRAF V600EMelanoma Stage III, Melanoma Stage IV, BRAF V600 Mutation

32. Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

    Active, not recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2018Primary completion 2024-12 NCT03543969

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    … must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600E mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical …

    BRAF V600EMelanoma (Skin), Skin Cancer, Skin Melanoma, Skin Carcinoma

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