[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immatics US, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,78],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Melanoma, Cutaneous Malignant","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2025-01-14",{"date":36,"type":21},"2031-10",{"name":38,"class":39},"Immatics US, Inc.","INDUSTRY",66,{"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":51,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100338413","phase-1-actengine-ima203ima203cd8-as-monotherapy-or-in-combination-with-nivolumab-in-recurrent-andor-refractory-solid-tumors-100338413","NCT03686124","ACTengine® IMA203\u002FIMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and\u002For Refractory Solid Tumors","Phase 1\u002F2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer\u002FGermline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and\u002For Refractory Solid Tumors","ACTengine","Inclusion Criteria:\n\n* Patients must have recurrent\u002Fprogressing and\u002For refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* HLA-A\\*02:01 positive\n* For patients with ovarian\u002Ffallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.\n* Measurable disease according to RECIST 1.1\n* Adequate selected organ function per protocol\n* Patient's tumor must express tumor antigen by \"IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.\n* Life expectancy more than 5 months\n* Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203\u002FIMA203CD8\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203\u002FIMA203CD8\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\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 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* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Patients with LDH greater than 2.0-fold ULN.\n* Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and\u002For IMA203\u002FIMA203CD8 treatment\n* Patients with active brain metastases\n* Concurrent treatment in another clinical trial.\n* For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1\u002FPD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply",{"count":50,"type":21},375,[52,53],"PHASE1","PHASE2","The study's purpose is to establish the safety and tolerability of IMA203\u002FIMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).",[56,57,58,59],"Refractory Cancer","Recurrent Cancer","Solid Tumor, Adult","Cancer",[61,62,63,64,65,66,67,68],"T-cell therapy","immunotherapy","Melanoma (Skin)","Melanoma, Uveal","Ovarian Carcinoma","Uterine Carcinoma","Uterine Carcinosarcoma","Immatics","2026-05-12",{"date":71,"type":32},"2026-05-13",{"date":73,"type":32},"2019-05-14",{"date":75,"type":21},"2032-06",{"name":38,"class":39},21,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100588809","phase-1-actengine-ima203-combined-with-mrna-4203-100588809","NCT06946225","ACTengine® IMA203 Combined With mRNA-4203","A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)","Inclusion Criteria:\n\n* Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) 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* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n* Life expectancy more than 5 months\n* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor\n* SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.\n* Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration\n\nOther protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease\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 hypersensitivity to cyclophosphamide, fludarabine, or IL-2\n* History of hypersensitivity to mRNA-based medicines\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* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol\n* Participants with active brain metastases prior to lymphodepletion\n* Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment\n* Participants with renal impairment AND reduced bone marrow reserve per protocol\n\nOther protocol defined exclusion criteria could apply",{"count":86,"type":21},15,[52],"This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).",[90,91],"Cutaneous Melanoma","Synovial Sarcoma",[62,61,93,94,95,68,96],"cutaneous melanoma","synovial sarcoma","RNA vaccine","Moderna","2026-01-06",{"date":99,"type":32},"2026-01-08",{"date":101,"type":32},"2025-07-25",{"date":103,"type":21},"2029-08",{"name":38,"class":39},4,""]