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Clinical trials for V600E

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44349   clinical trials with a EudraCT protocol, of which   7376   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    67 result(s) found for: V600E. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2020-001288-99 Sponsor Protocol Number: C4221015 Start Date*: 2020-11-26
    Sponsor Name:Pfizer Inc.
    Full Title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND C...
    Medical condition: Colorectal cancer (BRAF V600E-mutant mCRC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Ongoing) DE (Ongoing) FR (Not Authorised) BE (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) SK (Trial now transitioned) BG (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-012293-12 Sponsor Protocol Number: NO25026 Start Date*: 2010-01-25
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously untreated Patients with Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF mutation Receiving Vemu...
    Medical condition: First-line therapy for adult patients with histologically confirmed metastatic melanoma (unresectable Stage IIIC or Stage IV) harbouring the V600E positive mutation
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) FR (Completed) SE (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-022838-85 Sponsor Protocol Number: MEK114267 Start Date*: 2010-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: MEK114267, A Phase III randomized, open-label study comparing GSK1120212 to chemotherapy in subjects with advanced or metastatic BRAF V600E/K mutation-positive melanoma
    Medical condition: Advanced or metastatic BRAF V600E/K mutation-positive melanoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) BE (Completed) CZ (Completed) GR (Completed) NO (Completed) GB (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000828-35 Sponsor Protocol Number: FFCD2006 Start Date*: 2022-11-07
    Sponsor Name:Fédération Francophone de Cancérologie Digestive
    Full Title: FFCD 2006 – NEORAF STUDY A MULTI-CENTRE, OPEN-LABEL, PILOT TRIAL EVALUATING THE COMBINATION ENCORAFENIB AND CETUXIMAB IN A NEOADJUVANT SETTING IN PATIENTS WITH LOCALISED COLON CANCER AND THE BRAF V...
    Medical condition: Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-023837-45 Sponsor Protocol Number: BRF113929 Start Date*: 2011-01-26
    Sponsor Name:GlaxoSmithKline
    Full Title: BRF113929: A Phase II Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects with BRAF Mutation-Positive Metastatic Melanoma to...
    Medical condition: BRAF V600E or V600K mutation-positive metastatic melanoma to the brain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004211-20 Sponsor Protocol Number: ML25597 Start Date*: 2016-09-30
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: A Single-Arm, Open-Label, Expanded Access Study of Vemurafenib in Patients With Metastatic Melanoma
    Medical condition: Metastatic melanoma with BRAF V600 mutation
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019526-14 Sponsor Protocol Number: E7080-G000-206 Start Date*: 2010-11-01
    Sponsor Name:Eisai Ltd
    Full Title: An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
    Medical condition: American Joint Committee on Cancer unresectable stage III or stage IV melanima and disease progression with subjects not harboring the V600E-BRAF mutation with disease progression following first l...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001705-87 Sponsor Protocol Number: BRF117019 Start Date*: 2014-03-06
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase II, Open-label, Study in Subjects with BRAF V600E Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and ...
    Medical condition: Mutations of BRAF V600E have been identified at a high frequency in melanoma, PTC, colorectal and ovarian cancers. Such mutations have also been reported in some rare cancers such as anaplastic t...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SE (Completed) BE (Completed) AT (Completed) DK (Completed) NL (Completed) ES (Ongoing) NO (Completed)
    Trial results: View results
    EudraCT Number: 2020-005771-12 Sponsor Protocol Number: AIO-KRK-0420 Start Date*: 2022-05-30
    Sponsor Name:AIO-Studien-gGmbH
    Full Title: Neoadjuvant encorafenib, binimetinib and cetuximab for patients with BRAF V600E mutated/pMMR localized colorectal cancer
    Medical condition: Patients with unresected BRAFV600E mutated/pMMR localized colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009944 Colon cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001167 Adenocarcinoma of colon PT
    22.0 10022891 - Investigations 10075676 BRAF V600E mutation positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001161-41 Sponsor Protocol Number: BRF113928 Start Date*: 2012-09-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase II study of the BRAF inhibitor dabrafenib as a single agent and in combination with the MEK inhibitor trametinib in subjects with BRAF V600E mutation positive metastatic (stage IV) non-smal...
    Medical condition: Advanced non-small cell lung cancer and BRAF mutations
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NO (Completed) DE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000271-32 Sponsor Protocol Number: W00090GE201 Start Date*: 2018-11-11
    Sponsor Name:Pierre Fabre Médicament
    Full Title: Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer
    Medical condition: BRAF V600E -mutant Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Ongoing) BE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001482-57 Sponsor Protocol Number: SAKK_41/13-Aspirin Start Date*: 2016-09-19
    Sponsor Name:SAKK Swiss Group for Clinical Cancer Research
    Full Title: Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial
    Medical condition: PIK3CA mutated colon cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003715-26 Sponsor Protocol Number: C4221022 Start Date*: 2022-05-10
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC...
    Medical condition: MSI-H/dMMR metastatic colorectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) NO (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) BE (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000627-20 Sponsor Protocol Number: F8394-201 Start Date*: 2023-02-07
    Sponsor Name:Fore Biotherapeutics
    Full Title: A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations
    Medical condition: Tumors harboring BRAF alterations
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10075648 BRAF gene mutation PT
    22.0 10022891 - Investigations 10075676 BRAF V600E mutation positive PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004621-24 Sponsor Protocol Number: IFCT-1904 Start Date*: 2020-11-18
    Sponsor Name:IFCT
    Full Title: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer
    Medical condition: BRAFV600E-mutant metastatic Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    22.0 10022891 - Investigations 10075676 BRAF V600E mutation positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000087-30 Sponsor Protocol Number: Swecranio1-21 Start Date*: 2021-07-06
    Sponsor Name:Skane University Hospital, Dept of Endocrinology
    Full Title: Neoadjuvant and postoperative treatment with dabrafenib and trametinib for papillary craniopharyngioma
    Medical condition: Papillary craniopharyngioma
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004864 10084813 Papillary craniopharyngioma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002834-35 Sponsor Protocol Number: PARERE Start Date*: 2020-09-24
    Sponsor Name:G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
    Full Title: Randomized phase II study of PAnitumumab REchallenge followed by REgorafenib versus the reverse sequence in RAS and BRAF WILD-TYPE chemorefractory metastatic colorectal cancer patients.
    Medical condition: RAS and BRAF wild-type chemorefractory metastatic colorectal cancer patients
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000241-49 Sponsor Protocol Number: CNIR178X2201 Start Date*: 2017-12-05
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma
    Medical condition: Advanced solid tumors and non-Hodgkin lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) CZ (Completed) AT (Prematurely Ended) ES (Prematurely Ended) NL (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-000899-19 Sponsor Protocol Number: EVX-01-001 Start Date*: 2022-09-16
    Sponsor Name:Evaxion Biotech A/S
    Full Title: An open label, single arm trial evaluating the efficacy and safety of EVX-01 in combination with pembrolizumab in checkpoint inhibitor treatment naïve adults with unresectable or metastatic melanoma
    Medical condition: unresectable or metastatic melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004849-11 Sponsor Protocol Number: AIO-KRK-0116 Start Date*: 2016-09-29
    Sponsor Name:University Clinic od Munich-Großhadern (represented by the medical management)
    Full Title: Randomised study to investigate FOLFOXIRI plus cetuximab or FOLFOXIRI plus bevacizumab as first-line treatment of BRAF-mutated metastatic colorectal cancer (FIRE-4.5)
    Medical condition: Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum with metastases (metastatic colorectal cancer, mCRC), primarily non-resectable or surgery refused by the patient; RAS ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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