[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pierre Fabre Pharma GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100414233","braf-inhibitor-encorafenib-and-cetuximab-real-life-investigation-of-next-generation-crc-treatment-100414233",false,"NCT04673955","BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment","Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated, Colorectal Carcinoma: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland","BERING-CRC","Inclusion Criteria:\n\n* Written informed consent of the patient with regard to the pseudonymized documentation of his\u002Fher data in the frame of this non-interventional study\n* Legally capable patient ≥ 18 years of age (no upper limit)\n* Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy\n* Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;\n* Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.\n\nExclusion Criteria:\n\n* More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)\n* Prior treatment with any RAF-inhibitor or MEK-inhibitor.\n* Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs\n* Current or upcoming participation in an interventional clinical trial\n* Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma\n* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 months for patients with BRAF wild-type tumours. After 1st line therapy, treatment outcomes with standard therapy are poor in patients with BRAF-mutated mCRC, with response rates (ORR) of ≤ 11%, a median progression-free survival (mPFS) between 1.8 and 2.8 months, and a mOS between 4.1 and 6.2 months. Failure to achieve adequate survival outcomes with standard treatment regimens in patients with BRAF-mutated mCRC has encouraged efforts to combine multiple targeted therapies: With 665 randomized patients, the BEACON CRC trial represents the largest trial and is currently the only phase III study in patients with BRAFV600E-mutant mCRC.\n\nBERING CRC - designed as a prospective (allowing initial retrospective documentation), longitudinal, non-interventional study - will investigate the real-world effectiveness, quality of life, safety and tolerability of encorafenib and cetuximab in BRAFV600E-mutant mCRC patients, who have received prior systemic therapy. Data from this study will contribute to a deeper understanding and characterization to the everyday use of encorafenib and cetuximab in a broader patient population in the German, Austrian, and Swiss routine setting.",[25],"Metastatic Colorectal Carcinoma",[27],"BRAFV600E mutation","RECRUITING","2022-09-27",{"date":31,"type":32},"2022-09-29","ACTUAL",{"date":34,"type":32},"2020-09-03",{"date":36,"type":21},"2027-01",{"name":38,"class":39},"Pierre Fabre Pharma GmbH","INDUSTRY",70,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100366009","binimetinib-plus-encorafenib-real-life-investigation-of-next-generation-melanoma-treatment-100366009","NCT04045691","Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment","Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA","BERING","Inclusion Criteria:\n\n* Written informed consent of the patient with regard to the pseudonymized documentation as well as the transfer and processing of his\u002Fher data within the study and the ADOREG \\[Cancer Registry of German Working Group of Dermato-Oncology\\] registry (data transfer to ADOREG registry only for patients from German sites);\n* Legally capable male or female patient ≥ 18 years of age (no upper limit);\n* Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC \\[Summary of Product Characteristics\\] and by prescription; this decision was taken prior to and independent from the inclusion into the study;\n* Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;\n* Unresectable advanced or metastatic malignant melanoma with BRAF \\[Rapidly Accelerated Fibrosarcoma isoform B\\] V600 mutation;\n* Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 \\[Cytotoxic T-Lymphocyte Antigen-4\\] and\u002For anti-PD(L)1 \\[Programmed cell Death protein 1\\]) in the unresectable advanced or metastatic setting.\n\nExclusion Criteria:\n\n* Previous treatment with a BRAF- and\u002For MEK \\[Mitogen-Activated Protein\u002FExtracellular-signal Regulated Kinase\\]- inhibitor except for:\n\n  \\-- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended \\> 6 months prior start of Encorafenib\u002FBinimetinib treatment;\n* More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;\n* Any previous chemotherapeutic treatment of the melanoma disease;\n* Presence of any contraindication with regard to the encorafenib-binimetinib-treatment as specified in the corresponding SmPCs;\n* Current or upcoming participation in an interventional clinical trial;\n* Current or upcoming systemic treatment of any other tumor than melanoma;\n* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).",{"count":50,"type":21},750,"BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).",[53,54],"Melanoma Stage IV","Melanoma Stage III",[47,56,57],"Encorafenib","Binimetinib","2021-01-15",{"date":60,"type":32},"2021-01-19",{"date":62,"type":32},"2019-10-17",{"date":64,"type":21},"2027-09",{"name":38,"class":39},59,""]