[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fallopian-tube\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fallopian-tube":27},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100409086","phase-2-study-of-carboplatin-and-mirvetuximab-soravtansine-in-first-line-treatment-of-patients-receiving-neoadjuvant-chemotherapy-with-advanced-stage-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100409086",false,"NCT04606914","Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor α Positive","Inclusion Criteria:\n\n* Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.\n* Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy\n* Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity\n* Patients must have a performance status of 0 or 1.\n* Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \\>75% of cells\n* Patients must have adequate hematologic, liver and kidney functions defined as:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1,500\u002FμL)\n* Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without platelet transfusion in the prior 10 days\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n* Serum albumin ≥ 2 g\u002FdL\n* Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements\n* Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose\n* WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV\n\nExclusion Criteria:\n\n* Patients who have previously been treated with a systemic anti-cancer therapy\n* Patients with low-grade serous, endometrioid, clear cell, or mucinous histology\n* Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and \u002For monocular vision\n* Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:\n* History of hepatitis B or C infection (whether or not on active antiviral therapy)\n* History of human immunodeficiency virus (HIV) infection\n* Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV\n* Patients with a history of multiple sclerosis (MS) or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n* Patients with clinically significant cardiac disease including, but not limited to, any of the following:\n* Myocardial infarction ≤ 6 months prior to first dose\n* Unstable angina pectoris\n* Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n* Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n* Uncontrolled cardiac arrhythmias\n* Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n* Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n* Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis\n* Patients requiring use of folate-containing supplements (eg, folate deficiency)\n* Patients with prior hypersensitivity to monoclonal antibodies (mAb)\n* Women who are pregnant or breastfeeding\n* Patients who received prior treatment with MIRV or other FRα-targeting agents\n* Patients with untreated or symptomatic central nervous system (CNS) metastases\n* Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible","FEMALE","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \\>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and\u002For PARP inhibitors.",[26,27,28],"Ovarian Cancer","Fallopian Tube","Primary Peritoneal Cancer",[30,31,32,33],"First line treatment","Advanced epithelial ovarian cancer","mirvetuximab soravtansine","IMGN853","RECRUITING","2025-09-01",{"date":37,"type":38},"2025-09-08","ACTUAL",{"date":40,"type":38},"2021-05-27",{"date":42,"type":20},"2028-05-31",{"name":44,"class":45},"University of Alabama at Birmingham","OTHER",9]