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Dresden","Dresden","01307",{"type":110,"coordinates":719},[720,721],13.73832,51.05089,{"lat":721,"lon":720},{"facility":724,"status":103,"city":725,"state":98,"zip":726,"country":689,"countryCode":690,"cosmosGeoPoint":727,"geoPoint":731,"contacts":98},"Universitaetsklinikum Erlangen AöR","Erlangen","91054",{"type":110,"coordinates":728},[729,730],11.00783,49.59099,{"lat":730,"lon":729},{"facility":733,"status":103,"city":734,"state":98,"zip":735,"country":689,"countryCode":690,"cosmosGeoPoint":736,"geoPoint":740,"contacts":98},"Universitaetsklinikum Essen AöR","Essen","45147",{"type":110,"coordinates":737},[738,739],7.01228,51.45657,{"lat":739,"lon":738},{"facility":742,"status":103,"city":743,"state":98,"zip":744,"country":689,"countryCode":690,"cosmosGeoPoint":745,"geoPoint":749,"contacts":98},"Goethe University Frankfurt","Frankfurt am Main","60590",{"type":110,"coordinates":746},[747,748],8.68417,50.11552,{"lat":748,"lon":747},{"facility":751,"status":103,"city":752,"state":98,"zip":753,"country":689,"countryCode":690,"cosmosGeoPoint":754,"geoPoint":758,"contacts":98},"University Medical Center Hamburg-Eppendorf","Hamburg","20246",{"type":110,"coordinates":755},[756,757],9.99302,53.55073,{"lat":757,"lon":756},{"facility":760,"status":103,"city":761,"state":98,"zip":762,"country":689,"countryCode":690,"cosmosGeoPoint":763,"geoPoint":767,"contacts":98},"Universitaetsklinikum Heidelberg AöR","Heidelberg","69120",{"type":110,"coordinates":764},[765,766],8.69079,49.40768,{"lat":766,"lon":765},{"facility":769,"status":103,"city":770,"state":98,"zip":771,"country":689,"countryCode":690,"cosmosGeoPoint":772,"geoPoint":776,"contacts":98},"Universitaet Leipzig","Leipzig","04103",{"type":110,"coordinates":773},[774,775],12.37129,51.33962,{"lat":775,"lon":774},{"facility":778,"status":103,"city":779,"state":98,"zip":780,"country":689,"countryCode":690,"cosmosGeoPoint":781,"geoPoint":785,"contacts":98},"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","Mainz","55131",{"type":110,"coordinates":782},[783,784],8.28008,49.98185,{"lat":784,"lon":783},{"facility":787,"status":656,"city":788,"state":98,"zip":789,"country":790,"countryCode":791,"cosmosGeoPoint":792,"geoPoint":796,"contacts":98},"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","Amsterdam","1066 CX","Netherlands","NL",{"type":110,"coordinates":793},[794,795],4.88969,52.37403,{"lat":795,"lon":794},{"facility":798,"status":656,"city":799,"state":98,"zip":800,"country":790,"countryCode":791,"cosmosGeoPoint":801,"geoPoint":805,"contacts":98},"Universitair Medisch Centrum Groningen","Groningen","9713 GZ",{"type":110,"coordinates":802},[803,804],6.56667,53.21917,{"lat":804,"lon":803},{"facility":807,"status":656,"city":808,"state":98,"zip":809,"country":790,"countryCode":791,"cosmosGeoPoint":810,"geoPoint":814,"contacts":98},"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","Rotterdam","3015 GD",{"type":110,"coordinates":811},[812,813],4.47917,51.9225,{"lat":813,"lon":812},{"facility":816,"status":656,"city":817,"state":98,"zip":818,"country":819,"countryCode":820,"cosmosGeoPoint":821,"geoPoint":825,"contacts":98},"Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital","Cambridge","CB2 0QQ","United Kingdom","UK",{"type":110,"coordinates":822},[823,824],0.11667,52.2,{"lat":824,"lon":823},{"facility":827,"status":656,"city":828,"state":98,"zip":829,"country":819,"countryCode":820,"cosmosGeoPoint":830,"geoPoint":834,"contacts":98},"Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center","Glasgow","G12 0YN",{"type":110,"coordinates":831},[832,833],-4.25763,55.86515,{"lat":833,"lon":832},{"facility":836,"status":103,"city":837,"state":98,"zip":838,"country":819,"countryCode":820,"cosmosGeoPoint":839,"geoPoint":843,"contacts":98},"Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital","London","SE1 9RT",{"type":110,"coordinates":840},[841,842],-0.12574,51.50853,{"lat":842,"lon":841},{"facility":845,"status":656,"city":837,"state":98,"zip":846,"country":819,"countryCode":820,"cosmosGeoPoint":847,"geoPoint":849,"contacts":98},"The Royal Marsden NHS Foundation Trust","SW3 6JJ",{"type":110,"coordinates":848},[841,842],{"lat":842,"lon":841},{"facility":851,"status":656,"city":852,"state":98,"zip":853,"country":819,"countryCode":820,"cosmosGeoPoint":854,"geoPoint":858,"contacts":98},"The Christie NHS Foundation Trust","Manchester","M20 4GJ",{"type":110,"coordinates":855},[856,857],-2.23743,53.48095,{"lat":857,"lon":856},{"facility":860,"status":656,"city":861,"state":98,"zip":862,"country":819,"countryCode":820,"cosmosGeoPoint":863,"geoPoint":867,"contacts":98},"Oxford University Hospitals NHS Foundation Trust, Churchill Hospital","Oxford","OX3 7LE",{"type":110,"coordinates":864},[865,866],-1.25596,51.75222,{"lat":866,"lon":865},{"facility":869,"status":656,"city":870,"state":98,"zip":871,"country":819,"countryCode":820,"cosmosGeoPoint":872,"geoPoint":876,"contacts":98},"University of Southampton NHS Foundation Trust, Southampton General Hospital","Southampton","SO16 6YD",{"type":110,"coordinates":873},[874,875],-1.40428,50.90395,{"lat":875,"lon":874},{"type":878,"investigatorFullName":98,"investigatorTitle":98,"investigatorAffiliation":98,"oldNameTitle":98,"oldOrganization":98},"SPONSOR","100573195","phase-3-suprame-actengine-ima203-vs-investigators-choice-of-treatment-in-previously-treated-unresectable-or-metastatic-cutaneous-melanoma-100573195",false,"NCT06743126","SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma","A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)","SUPRAME","Inclusion Criteria:\n\n* Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease\n* HLA-A\\*02:01 positive\n* Adequate selected organ function per protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma\n* Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient\n* Life expectancy more than 6 months\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n* Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization and prior to trial treatment start.\n\nExclusion Criteria:\n\n* Primary mucosal or uveal melanoma\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.\n* History of cardiac conditions as per protocol\n* Prior allogenic stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician\n* History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs \u002F SmPCs\n* Known hypersensitivity to any of the rescue medications\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Any condition contraindicating leukapheresis\n* Pregnant or breastfeeding\n* Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)\n* Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,\n* Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.\n* Patients with any active infection or ongoing reactivation of infection\n* Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months\n* Prior treatment with IMA203\n* Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months\n* Patients with LDH greater than 2.0-fold ULN\n* Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment\n* Patients with active brain metastases or leptomeningeal metastases\n* Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization\n* Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment\n* Other protocol defined inclusion\u002Fexclusion criteria could apply","ALL","18 Years",{"count":890,"type":891},360,"ESTIMATED","INTERVENTIONAL",[894],"PHASE3","This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.\n\nFor patients interested in additional information on how to participate, please follow this link: https:\u002F\u002Fmytomorrows.com\u002Ftrials\u002Fsuprame\u002Fen-us\u002F",[897],"Melanoma, Cutaneous Malignant","2026-06-08",{"date":900,"type":901},"2026-06-10","ACTUAL",{"date":903,"type":901},"2025-01-14",{"date":905,"type":891},"2031-10",{"name":5,"class":6},66]