[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523316":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":104,"collaborators":106,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":20,"studyType":128,"phases":129,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":93,"whyStopped":20,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Peptide vaccination","EXPERIMENTAL","Peptides will be administered subcutaneously (s.c.) together with the novel toll like receptor (TLR) 1\u002F2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant.\n\nThree vaccinations will be applied every 28 days.",[13],"Biological: Peptide vaccine IPX",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Peptide vaccine IPX","Peptide vaccine is a combination of\n\n1. class II peptide spanning the sarcoma-specific fusion-breakpoint (fusion-peptide)\n2. class-II neopeptide based on a patient-individual nonsynonymous mutation with a high immunogenicity (mutation-based neopeptide).\n3. control peptide derived from Survivin.\n4. adjuvant: toll like receptor (TLR) 1\u002F2 ligand XS15.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Martin Ebinger, Prof. Dr.","University children's hospital Tübingen","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+49 7071 2983781","martin.ebinger@med.uni-tuebingen.de",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Joachim Rupprecht, Dr.","joachim.rupprecht@med.uni-tuebingen.de",[35,57,73,91],{"facility":36,"status":37,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Pediatrics III, West German Cancer Centre, University Hospital","NOT_YET_RECRUITING","Essen","45147","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],7.01228,51.45657,{"lat":46,"lon":45},[49,53],{"name":50,"role":28,"phone":51,"phoneExt":20,"email":52},"Uta Dirksen, Prof.","0049.201.7238084","uta.dirksen@uk-essen.de",{"name":54,"role":28,"phone":55,"phoneExt":20,"email":56},"Dirk Reinhardt","0049-201-7233784","dirk.reinhardt@uk-essen.de",{"facility":58,"status":37,"city":59,"state":20,"zip":60,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Universitätsklinikum, Klinik für Kinder- und Jugendmedizin","Frankfurt am Main","60590",{"type":43,"coordinates":62},[63,64],8.68417,50.11552,{"lat":64,"lon":63},[67,70],{"name":68,"role":28,"phone":69,"phoneExt":20,"email":20},"Konrad Bochennek, Dr.","+49 69 6301-5243",{"name":71,"role":28,"phone":72,"phoneExt":20,"email":20},"Eva Rettinger, Dr.","+49 69 6301-5040",{"facility":74,"status":37,"city":75,"state":20,"zip":76,"country":40,"countryCode":41,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum","Freiburg im Breisgau","79106",{"type":43,"coordinates":78},[79,80],7.85222,47.9959,{"lat":80,"lon":79},[83,87],{"name":84,"role":28,"phone":85,"phoneExt":20,"email":86},"Simone Hettmer, Prof. Dr.","+49 761 27043000","simone.hettmer@uniklinik-freiburg.de",{"name":88,"role":28,"phone":89,"phoneExt":20,"email":90},"Christian Flotho, Prof. Dr.","+49 761 27046280","christian.flotho@uniklinik-freiburg.de",{"facility":92,"status":93,"city":94,"state":20,"zip":95,"country":40,"countryCode":41,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University Children's Hostpital","RECRUITING","Tübingen","72076",{"type":43,"coordinates":97},[98,99],9.05222,48.52266,{"lat":99,"lon":98},[102,103],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},{"type":105,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[107,110,112],{"name":108,"class":109},"Deutsches Konsortium fürTranslationale Krebsforschung (DKTK)","UNKNOWN",{"name":111,"class":109},"Cooperative Ewing Sarkom Studiengruppe",{"name":113,"class":6},"Cooperative Weichteilsarkom Study Group","100523316","phase-1-personalized-vaccination-in-fusion-sarcoma-patients-pervision-100523316",false,"NCT06094101","Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)","Prospective Phase I\u002FII Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment","PerVision","Inclusion Criteria, definition of partial remission plus (PRplus)\n\n* Screening Stage 1:\n\n  * Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.\n  * Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER (Register study Molecularly Aided Stratification for Tumor Eradication) or HEROES-AYA networks (Heterogeneity, evolution and resistance of fusion-driven sarcomas in AYA) or similar evaluation.\n* Screening stage 2:\n\n  * Design and production of the patient-individual vaccine cocktail was successful\n  * Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and\u002For maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed. Definition of PRplus: Partial remission(plus) implicates that all remaining tumor residua including all metastases have received local therapy by this time point: Either surgical removal or local irradiation. The assessment of which therapy modality and, in the case of irradiation, which radiation dose is selected, lies with the treating physician. Whether PRplus is achieved will be decided finally by the investigator after review of the patient records.\n\nExclusion Criteria:\n\n* Ejection fraction \\\u003C 25%\n* Creatinine-clearance \\\u003C 40ml\u002Fmin\n* Bilirubin \\> 4mg\u002Fdl\n* Alanine aminotransferase (ALT) \\> 400 units (U)\u002Fl and\u002For aspartate aminotransferase (AST) \\> 400 U\u002Fl\n* Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen\u002Fantibody or nucleic acid tests \\[NAT\\]) and CD4-positive cells \\\u003C 500\u002Fμl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\]) and hepatitis B NAT test \\> 2000 IU\u002Fml). Hepatitis C virus: positive for heavy chain only antibody \\[HCAb\\] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)\n* Subjects with a known hypersensitivity \u002F allergy to any component of the study drugs.\n* Subjects who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).\n* Subjects with a prior haematopoietic stem cell transplantation \u002F prior organ transplantation.\n* Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.\n* Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence functionality and activity of T cells, such as steroids (more than 0,5 mg\u002Fkg body weight prednisolone-equivalent), calcineurin-inhibitors, mofetil mycophenolate, sirolimus, everolimus, and cytotoxic medication. Those drugs should be avoided until 28 days after third\u002Ffinal vaccination but may be given after discussion with the principal investigator. Application of tyrosine kinase inhibitors is permitted during the trial (only stage 2).\n* Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.\n* Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy\u002Fleucoencephalopathy (\\> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).\n* Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment\n* Pregnant females\n* Female subjects of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior to Screening stage 2 visit to 180 days after the last vaccination.\n* Male subjects of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.\n* Not willing and\u002For not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.\n* History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may include but is not limited to: history of central nervous system or cardiovascular disease, history of relevant drug allergies, history of psychiatric disorder, history or present of clinically significant pathology.\n* Karnofsky performance status of \\\u003C 70% for subjects ≥ 16 years of age, Lansky performance status of \\\u003C 70% for subjects \\\u003C 16 years of age\n* Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the \"frontline and relapsed rhabdomyosarcoma study\"( (FaR-RMS) after completion of the maintenance therapy (EudraCT-2018-000515-24)). Commonly used drugs as per standard or phase III-trials are permitted.","ALL","2 Years","40 Years",{"count":126,"type":127},30,"ESTIMATED","INTERVENTIONAL",[130,131],"PHASE1","PHASE2","The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.\n\nThis approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.\n\nIt is an interventional, multicenter, open-label, phase I\u002FII feasibility and early proof of concept study evaluating a personalized peptide vaccine.\n\nPrimary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.",[134,135,136],"Ewing Sarcoma","Rhabdomyosarcoma","Synovial Sarcoma",[138,139,140],"metastasized fusion-driven sarcoma","clinical study","phase I\u002FII","2026-04-28",{"date":143,"type":144},"2026-05-04","ACTUAL",{"date":146,"type":144},"2023-09-19",{"date":148,"type":127},"2027-09",{"name":5,"class":6},4]