[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591256":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":37,"locations":21,"responsibleParty":43,"collaborators":21,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":21,"enrollmentInfo":55,"targetDuration":21,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":21,"overallStatus":64,"whyStopped":21,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":21},{"fullName":5,"class":6},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FLOT plus Bemarituzumab","EXPERIMENTAL","* FLOT will be administered every 2 weeks (Q2W). Docetaxel 50 mg\u002Fm2 is given as 1 hour infusion, followed by Oxaliplatin 85mg\u002Fm2 as a 2-hour infusion, leucovorin 200 mg\u002Fm2 over 2 hours and 5-FU 2600 mg\u002Fm2 as a 24 hour-infusion,\n* Bemarituzumab will be administered as IV infusion",[13,14],"Drug: Bemarituzumab","Drug: FLOT",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Bemarituzumab","• Bemarituzumab will be given as a IV infusion",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"FLOT","FLOT will be given as a IV infusion",[9],[27,31,34],{"name":28,"affiliation":29,"role":30},"Markus Moehler","University Medical Center Mainz","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Elizabeth Smyth","University of Oxford",{"name":35,"affiliation":36,"role":30},"Maike Collienne","University Medical Center Mannheim",[38],{"name":39,"role":40,"phone":41,"phoneExt":21,"email":42},"EORTC EORTC","CONTACT","+32 27741611","eortc@eortc.org",{"type":44,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100591256","phase-1-peri-operative-treatment-of-resectable-gastroesophageal-cancer-using-bemarituzumab-bema-plus-perioperative-treatment-100591256",false,"NCT06978062","Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment","An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)","NeoBEMA","Inclusion Criteria:\n\n* Signed screening informed consent\n* Age ≥ 18 years\n* Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).\n* Histologically proven, previously untreated, locally advanced, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.\n* Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection\n* Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+\u002F3+ FGFR2b staining by immunohistochemistry (IHC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Previously untreated, locally advanced, histologically confirmed, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging\n* Adequate hematologic and organ function\n\nExclusion Criteria:\n\n* Prior anticancer treatment for the disease under investigation\n* History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids\n* Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing\n* Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.\n* Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment\n* History of solid organ transplantation\n* History of interstitial lung disease\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study\n* Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg\u002Fday prednisolone is allowed. Inhaled, intranasal, intraocular, and\u002For joint injections of corticosteroids are allowed.","ALL","18 Years",{"count":56,"type":57},27,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.",[63],"GastroEsophageal Cancer","NOT_YET_RECRUITING","2025-06-02",{"date":67,"type":68},"2025-06-05","ACTUAL",{"date":70,"type":57},"2026-02-20",{"date":72,"type":57},"2029-09-28",{"name":5,"class":6}]