[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100349634":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":56,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":29,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":29,"overallStatus":38,"whyStopped":29,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IMGN853","EXPERIMENTAL","IMGN853 administered 6 mg\u002Fkg adjusted ideal body weight (AIBW) once every three weeks (Q3W)",[13],"Drug: IMGN853",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","IMGN853 6 mg\u002Fkg intravenously every 3 weeks until disease progression",[9],[20],"mirvetuximab soravtansine",[22],{"name":23,"affiliation":5,"role":24},"Alessandro D. Santin, M.D.","PRINCIPAL_INVESTIGATOR",[26,31],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","203-737-4450",null,"alessandro.santin@yale.edu",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"Lisa Baker, R.N.","203-785-6398","lisa.baker@yale.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Smilow Cancer Hospital at Yale New Haven","RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-72.92816,41.30815,{"lat":48,"lon":47},[51,53,54],{"name":52,"role":27,"phone":28,"phoneExt":29,"email":30},"Alessandro D Santin, M.D.",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},{"name":55,"role":24,"phone":29,"phoneExt":29,"email":29},"Alessandro Santin, M.D.",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Alessandro Santin","Professor of Obstetrics, Gynecology, and Reproductive Sciences",[61,64],{"name":62,"class":63},"ImmunoGen, Inc.","INDUSTRY",{"name":65,"class":63},"AbbVie","100349634","phase-2-evaluation-of-mirvetuximab-soravtansine-imgn853-in-women-with-folate-receptor--positive-endometrial-cancer-100349634",false,"NCT03832361","Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer","A Phase II Evaluation of the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Persistent or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Radiologically confirmed (ie, CT scan and\u002For MRI) persistent or recurrent endometrial cancer\n* Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, Carcinosarcoma with high grade serous or Grade 2\u002F3 endometrioid components, or clear cell carcinoma (Pure or Mixed).\n* Have measurable disease\n* FRα-positive tumor expression as defined in the protocol\n* Have at least one \"target lesion\" to be used to assess response as defined by RECIST v1.1\n* Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed\n* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment\n* Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy\n* Patients must have adequate hematologic, liver and kidney function as defined in the protocol\n* Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853\n* WCBP must have a negative pregnancy test within 4 days prior to the first dose of study treatment\n* At time of initial surgery, patient may have either been optimally or suboptimally debulked\n* Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Active or chronic corneal disorder\n* Serious concurrent illness or clinically-relevant active infection as defined in the protocol\n* Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy\n* History of neurological conditions\n* History of hemorrhagic or ischemic stroke within the last 6 months\n* History of cirrhotic liver disease\n* Previous clinical diagnosis of non-infectious pneumonitis\n* Prior hypersensitivity to monoclonal antibodies\n* Women who are pregnant or breast feeding\n* Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis\n* History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment\n* Required used of folate-containing supplements (e.g. folate deficiency)\n* Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment","FEMALE","18 Years","100 Years",{"count":77,"type":78},50,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).",[84],"Endometrial Cancer","2026-06-23",{"date":87,"type":88},"2026-06-26","ACTUAL",{"date":90,"type":88},"2020-07-15",{"date":92,"type":78},"2028-10",{"name":58,"class":6},1]