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Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy","Warsaw","02781",{"type":59,"coordinates":661},[662,663],21.01178,52.22977,{"lat":663,"lon":662},{"facility":666,"status":52,"city":667,"state":30,"zip":668,"country":669,"countryCode":670,"cosmosGeoPoint":671,"geoPoint":675,"contacts":30},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":59,"coordinates":672},[673,674],2.15899,41.38879,{"lat":674,"lon":673},{"facility":677,"status":52,"city":667,"state":30,"zip":678,"country":669,"countryCode":670,"cosmosGeoPoint":679,"geoPoint":681,"contacts":30},"Hospital Clinico de Barcelona","08036",{"type":59,"coordinates":680},[673,674],{"lat":674,"lon":673},{"facility":683,"status":52,"city":684,"state":30,"zip":685,"country":669,"countryCode":670,"cosmosGeoPoint":686,"geoPoint":690,"contacts":30},"Hospital General Universitario Gregorio Marañon","Madrid","28007",{"type":59,"coordinates":687},[688,689],-3.70256,40.4165,{"lat":689,"lon":688},{"facility":692,"status":52,"city":684,"state":30,"zip":693,"country":669,"countryCode":670,"cosmosGeoPoint":694,"geoPoint":696,"contacts":30},"Hospital Universitario Ramon y Cajal","28034",{"type":59,"coordinates":695},[688,689],{"lat":689,"lon":688},{"facility":698,"status":52,"city":699,"state":30,"zip":700,"country":669,"countryCode":670,"cosmosGeoPoint":701,"geoPoint":705,"contacts":30},"Hospital Regional Universitario de Malaga","Málaga","29010",{"type":59,"coordinates":702},[703,704],-4.42034,36.72016,{"lat":704,"lon":703},{"facility":707,"status":52,"city":708,"state":30,"zip":709,"country":669,"countryCode":670,"cosmosGeoPoint":710,"geoPoint":714,"contacts":30},"Hospital General Universitario de Valencia","Valencia","46014",{"type":59,"coordinates":711},[712,713],-0.37966,39.47391,{"lat":713,"lon":712},{"facility":716,"status":52,"city":717,"state":30,"zip":718,"country":719,"countryCode":720,"cosmosGeoPoint":721,"geoPoint":725,"contacts":30},"Kantonsspital St. Gallen","Sankt Gallen","9000","Switzerland","CH",{"type":59,"coordinates":722},[723,724],9.37477,47.42391,{"lat":724,"lon":723},{"facility":727,"status":52,"city":728,"state":30,"zip":729,"country":719,"countryCode":720,"cosmosGeoPoint":730,"geoPoint":734,"contacts":30},"Universitaetsspital Zurich","Zurich","8058",{"type":59,"coordinates":731},[732,733],8.55,47.36667,{"lat":733,"lon":732},{"facility":736,"status":52,"city":737,"state":738,"zip":739,"country":740,"countryCode":741,"cosmosGeoPoint":742,"geoPoint":746,"contacts":30},"Addenbrooke's Hospital","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":59,"coordinates":743},[744,745],0.11667,52.2,{"lat":745,"lon":744},{"facility":748,"status":52,"city":749,"state":750,"zip":751,"country":740,"countryCode":741,"cosmosGeoPoint":752,"geoPoint":756,"contacts":30},"The Christie NHS Foundation Trust","Manchester","England","M20 4BX",{"type":59,"coordinates":753},[754,755],-2.23743,53.48095,{"lat":755,"lon":754},{"facility":758,"status":52,"city":759,"state":760,"zip":761,"country":740,"countryCode":741,"cosmosGeoPoint":762,"geoPoint":766,"contacts":30},"Queen Elizabeth Hospital","Birmingham","West Midlands","B15 2TH",{"type":59,"coordinates":763},[764,765],-1.89983,52.48142,{"lat":765,"lon":764},{"facility":768,"status":52,"city":769,"state":30,"zip":770,"country":740,"countryCode":741,"cosmosGeoPoint":771,"geoPoint":775,"contacts":30},"Leeds General Infirmary","Leeds","LS1 3EX",{"type":59,"coordinates":772},[773,774],-1.54785,53.79648,{"lat":774,"lon":773},{"facility":777,"status":52,"city":778,"state":30,"zip":779,"country":740,"countryCode":741,"cosmosGeoPoint":780,"geoPoint":784,"contacts":30},"Guys & St Thomas' NHS Foundation Trust","London","SE1 9RT",{"type":59,"coordinates":781},[782,783],-0.12574,51.50853,{"lat":783,"lon":782},{"facility":786,"status":52,"city":778,"state":30,"zip":779,"country":740,"countryCode":741,"cosmosGeoPoint":787,"geoPoint":789,"contacts":30},"Sarah Cannon Research Institute UK",{"type":59,"coordinates":788},[782,783],{"lat":783,"lon":782},{"facility":791,"status":52,"city":778,"state":30,"zip":792,"country":740,"countryCode":741,"cosmosGeoPoint":793,"geoPoint":795,"contacts":30},"Royal Marsden Hospital - Chelsea","SW3 6JJ",{"type":59,"coordinates":794},[782,783],{"lat":783,"lon":782},{"facility":797,"status":52,"city":798,"state":30,"zip":799,"country":740,"countryCode":741,"cosmosGeoPoint":800,"geoPoint":804,"contacts":30},"Mount Vernon Cancer Center","Middlesex","HA6 2RN",{"type":59,"coordinates":801},[802,803],-0.26856,51.53174,{"lat":803,"lon":802},{"facility":806,"status":52,"city":807,"state":30,"zip":808,"country":740,"countryCode":741,"cosmosGeoPoint":809,"geoPoint":813,"contacts":30},"Royal Marsden Hospital - Sutton","Sutton","SM2 5PT",{"type":59,"coordinates":810},[811,812],-0.2,51.35,{"lat":812,"lon":811},{"type":815,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100481461","phase-3-tebentafusp-regimen-versus-investigators-choice-in-previously-treated-advanced-melanoma-tebe-am-100481461",false,"NCT05549297","Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)","Phase 2\u002F3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)","Inclusion Criteria:\n\n* HLA-A\\*02:01-positive\n* unresectable Stage III or Stage IV non-ocular melanoma\n* archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.\n* measurable or non-measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* If applicable, must agree to use highly effective contraception\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol\n* Must agree to provide protocol specified samples for biomarker analyses.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* diagnosis of ocular or metastatic uveal melanoma\n* history of a malignant disease other than those being treated in this study\n* ineligible to be retreated with pembrolizumab due to a treatment-related AE\n* known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)\n* active autoimmune disease requiring immunosuppressive treatment\n* known psychiatric or substance abuse disorders\n* received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications.\n* received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose\n* received cellular therapies within 90 days of study intervention\n* ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study\n* received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose\n* have not progressed on treatment with an anti-PD(L)1 mAb\n* have not received prior treatment with an approved anti-CTLA-4 mAb\n* have a BRAF V600 mutation, who have not received a prior BRAF\u002FMEK TKI regimen\n* currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose\n* known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function\n* Out of range Laboratory values\n* history of allogenic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":826,"type":827},540,"ESTIMATED","INTERVENTIONAL",[830],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \\[SoC\\], best supportive care \\[BSC\\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.",[833],"Advanced Melanoma",[835,836,27,837,838,839,840,841,842,843,844,845,846,847,848,849,850],"Melanoma","IMCgp100","Cutaneous Melanoma","Immunotherapy","gp100","TCR","Pembrolizumab","Bispecific T cell receptor fusion protein","ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer)","Immune mobilizing monoclonal T cell receptor against cancer","KIMMTRAK","Acral Melanoma","Mucosal Melanoma","Blue Nevus","anti-PDL1","checkpoint therapy","2026-02-23",{"date":853,"type":854},"2026-02-25","ACTUAL",{"date":856,"type":854},"2022-12-19",{"date":858,"type":827},"2028-07",{"name":5,"class":6},82]