[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alessandro Santin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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":5},"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":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"Endometrial Cancer","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":32},"2020-07-15",{"date":36,"type":21},"2028-10",{"name":38,"class":39},"Alessandro Santin","OTHER",""]