[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544205":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":421,"collaborators":34,"id":423,"slug":424,"hasResults":425,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":34,"eligibilityCriteria":429,"healthyVolunteers":425,"sex":430,"minAge":431,"maxAge":34,"enrollmentInfo":432,"targetDuration":34,"studyType":435,"phases":436,"briefSummary":438,"conditions":439,"keywords":34,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Prophylactic Steroid Eye Drops","EXPERIMENTAL","Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)\u002Fkilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days.",[13,14,15],"Drug: Mirvetuximab Soravtansine","Drug: Lubricating Eye Drops","Drug: Prednisolone acetate ophthalmic suspension 1% eye drops",{"label":17,"type":10,"description":18,"interventionNames":19},"Primary Prophylactic Vasoconstricting Eye Drops","Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg\u002Fkg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days.",[13,14,20],"Drug: Brimonidine tartrate ophthalmic solution eye drops",[22,30,35,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Mirvetuximab Soravtansine","Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.",[9,17],[28,29],"IMGN853","MIRV",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Lubricating Eye Drops","Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.",[9,17],null,{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Prednisolone acetate ophthalmic suspension 1% eye drops","Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.",[9],{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Brimonidine tartrate ophthalmic solution eye drops","Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.",[17],[44],{"name":45,"affiliation":5,"role":46},"ABBVIE INC.","STUDY_DIRECTOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":34,"email":52},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[54,68,79,89,99,110,120,130,136,146,156,166,175,187,191,201,213,223,232,237,247,256,268,274,280,292,302,311,321,331,337,348,354,366,376,385,391,400,406,412],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":34},"University of California Los Angeles \u002FID# 269339","RECRUITING","Los Angeles","California","90095","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-118.24368,34.05223,{"lat":66,"lon":65},{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":60,"countryCode":61,"cosmosGeoPoint":74,"geoPoint":78,"contacts":34},"Norton Cancer Institute - St. Matthews \u002FID# 269070","COMPLETED","Louisville","Kentucky","40207",{"type":63,"coordinates":75},[76,77],-85.75941,38.25424,{"lat":77,"lon":76},{"facility":80,"status":56,"city":81,"state":82,"zip":83,"country":60,"countryCode":61,"cosmosGeoPoint":84,"geoPoint":88,"contacts":34},"Holy Cross Hospital - Silver Spring \u002FID# 269344","Silver Spring","Maryland","20910",{"type":63,"coordinates":85},[86,87],-77.02609,38.99067,{"lat":87,"lon":86},{"facility":90,"status":56,"city":91,"state":92,"zip":93,"country":60,"countryCode":61,"cosmosGeoPoint":94,"geoPoint":98,"contacts":34},"Mercy David C. Pratt Cancer Center \u002FID# 269350","St Louis","Missouri","63141",{"type":63,"coordinates":95},[96,97],-90.19789,38.62727,{"lat":97,"lon":96},{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":60,"countryCode":61,"cosmosGeoPoint":105,"geoPoint":109,"contacts":34},"The Center Of Hope \u002FID# 269348","ACTIVE_NOT_RECRUITING","Reno","Nevada","89511",{"type":63,"coordinates":106},[107,108],-119.8138,39.52963,{"lat":108,"lon":107},{"facility":111,"status":56,"city":112,"state":113,"zip":114,"country":60,"countryCode":61,"cosmosGeoPoint":115,"geoPoint":119,"contacts":34},"Holy Name Medical Center \u002FID# 269340","Teaneck","New Jersey","07666",{"type":63,"coordinates":116},[117,118],-74.01597,40.8976,{"lat":118,"lon":117},{"facility":121,"status":70,"city":122,"state":123,"zip":124,"country":60,"countryCode":61,"cosmosGeoPoint":125,"geoPoint":129,"contacts":34},"New York Oncology Hematology - Albany Cancer Center \u002FID# 269345","Albany","New York","12206-5013",{"type":63,"coordinates":126},[127,128],-73.75623,42.65258,{"lat":128,"lon":127},{"facility":131,"status":70,"city":122,"state":123,"zip":132,"country":60,"countryCode":61,"cosmosGeoPoint":133,"geoPoint":135,"contacts":34},"Women'S Cancer Care Associates \u002FID# 269980","12208",{"type":63,"coordinates":134},[127,128],{"lat":128,"lon":127},{"facility":137,"status":56,"city":138,"state":139,"zip":140,"country":60,"countryCode":61,"cosmosGeoPoint":141,"geoPoint":145,"contacts":34},"Duke Cancer Institute \u002FID# 269342","Durham","North Carolina","27710",{"type":63,"coordinates":142},[143,144],-78.89862,35.99403,{"lat":144,"lon":143},{"facility":147,"status":56,"city":148,"state":149,"zip":150,"country":60,"countryCode":61,"cosmosGeoPoint":151,"geoPoint":155,"contacts":34},"Summa Health \u002FID# 269349","Akron","Ohio","44304-1407",{"type":63,"coordinates":152},[153,154],-81.51901,41.08144,{"lat":154,"lon":153},{"facility":157,"status":56,"city":158,"state":159,"zip":160,"country":60,"countryCode":61,"cosmosGeoPoint":161,"geoPoint":165,"contacts":34},"UT Southwestern Medical Center \u002FID# 269341","Dallas","Texas","75390",{"type":63,"coordinates":162},[163,164],-96.80667,32.78306,{"lat":164,"lon":163},{"facility":167,"status":70,"city":168,"state":159,"zip":169,"country":60,"countryCode":61,"cosmosGeoPoint":170,"geoPoint":174,"contacts":34},"Memorial Hermann Southeast Hospital \u002FID# 269347","Houston","77089",{"type":63,"coordinates":171},[172,173],-95.36327,29.76328,{"lat":173,"lon":172},{"facility":176,"status":101,"city":177,"state":178,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":186,"contacts":34},"Blacktown Hospital \u002FID# 269305","Blacktown","New South Wales","2148","Australia","AU",{"type":63,"coordinates":183},[184,185],150.91667,-33.76667,{"lat":185,"lon":184},{"facility":188,"status":101,"city":189,"state":178,"zip":190,"country":180,"countryCode":181,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Newcastle Private Hosptial \u002FID# 269306","Lambton Heights","2305",{"facility":192,"status":101,"city":193,"state":194,"zip":195,"country":180,"countryCode":181,"cosmosGeoPoint":196,"geoPoint":200,"contacts":34},"Monash Health - Monash Medical Centre - Clayton \u002FID# 269304","Clayton","Victoria","3168",{"type":63,"coordinates":197},[198,199],145.11667,-37.91667,{"lat":199,"lon":198},{"facility":202,"status":70,"city":203,"state":204,"zip":205,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":34},"Universitair Ziekenhuis Antwerpen \u002FID# 269310","Edegem","Antwerpen","2650","Belgium","BE",{"type":63,"coordinates":209},[210,211],4.44504,51.15662,{"lat":211,"lon":210},{"facility":214,"status":101,"city":215,"state":216,"zip":217,"country":206,"countryCode":207,"cosmosGeoPoint":218,"geoPoint":222,"contacts":34},"OLV Ziekenhuis Aalst \u002FID# 269311","Aalst","Oost-Vlaanderen","9300",{"type":63,"coordinates":219},[220,221],4.0355,50.93604,{"lat":221,"lon":220},{"facility":224,"status":101,"city":225,"state":216,"zip":226,"country":206,"countryCode":207,"cosmosGeoPoint":227,"geoPoint":231,"contacts":34},"AZ Sint-Lucas \u002FID# 269307","Ghent","9000",{"type":63,"coordinates":228},[229,230],3.71667,51.05,{"lat":230,"lon":229},{"facility":233,"status":70,"city":225,"state":216,"zip":226,"country":206,"countryCode":207,"cosmosGeoPoint":234,"geoPoint":236,"contacts":34},"UZ Gent \u002FID# 269309",{"type":63,"coordinates":235},[229,230],{"lat":230,"lon":229},{"facility":238,"status":101,"city":239,"state":240,"zip":241,"country":206,"countryCode":207,"cosmosGeoPoint":242,"geoPoint":246,"contacts":34},"Universitair Ziekenhuis Leuven \u002FID# 269308","Leuven","Vlaams-Brabant","3000",{"type":63,"coordinates":243},[244,245],4.70093,50.87959,{"lat":245,"lon":244},{"facility":248,"status":70,"city":249,"state":34,"zip":250,"country":206,"countryCode":207,"cosmosGeoPoint":251,"geoPoint":255,"contacts":34},"CHU de Liege \u002FID# 269312","Liège","4000",{"type":63,"coordinates":252},[253,254],5.56749,50.63373,{"lat":254,"lon":253},{"facility":257,"status":101,"city":258,"state":259,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":34},"Universite de Montreal - Hopital Maisonneuve-Rosemont \u002FID# 268862","Montreal","Quebec","H1T 2M4","Canada","CA",{"type":63,"coordinates":264},[265,266],-73.58781,45.50884,{"lat":266,"lon":265},{"facility":269,"status":101,"city":258,"state":259,"zip":270,"country":261,"countryCode":262,"cosmosGeoPoint":271,"geoPoint":273,"contacts":34},"Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal \u002FID# 269314","H2L 4M1",{"type":63,"coordinates":272},[265,266],{"lat":266,"lon":265},{"facility":275,"status":101,"city":258,"state":259,"zip":276,"country":261,"countryCode":262,"cosmosGeoPoint":277,"geoPoint":279,"contacts":34},"McGill University Health Centre - Glen Site. \u002FID# 269313","H4A 3J1",{"type":63,"coordinates":278},[265,266],{"lat":266,"lon":265},{"facility":281,"status":101,"city":282,"state":283,"zip":284,"country":285,"countryCode":286,"cosmosGeoPoint":287,"geoPoint":291,"contacts":34},"Institut Paoli-Calmettes \u002FID# 269648","Marseille","Bouches-du-Rhone","13273","France","FR",{"type":63,"coordinates":288},[289,290],5.38107,43.29695,{"lat":290,"lon":289},{"facility":293,"status":101,"city":294,"state":295,"zip":296,"country":285,"countryCode":286,"cosmosGeoPoint":297,"geoPoint":301,"contacts":34},"Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau \u002FID# 269301","Tours","Indre-et-Loire","37000",{"type":63,"coordinates":298},[299,300],0.70398,47.39484,{"lat":300,"lon":299},{"facility":303,"status":101,"city":304,"state":304,"zip":305,"country":285,"countryCode":286,"cosmosGeoPoint":306,"geoPoint":310,"contacts":34},"Hopitaux Universitaires Paris Centre-Hopital Cochin \u002FID# 269330","Paris","75679",{"type":63,"coordinates":307},[308,309],2.3488,48.85341,{"lat":309,"lon":308},{"facility":312,"status":101,"city":313,"state":314,"zip":315,"country":285,"countryCode":286,"cosmosGeoPoint":316,"geoPoint":320,"contacts":34},"Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud \u002FID# 269327","Pierre-Bénite","Rhone","69310",{"type":63,"coordinates":317},[318,319],4.82424,45.70359,{"lat":319,"lon":318},{"facility":322,"status":101,"city":323,"state":324,"zip":325,"country":285,"countryCode":286,"cosmosGeoPoint":326,"geoPoint":330,"contacts":34},"Clinique Victor Hugo Le Mans \u002FID# 269985","Le Mans","Sarthe","72000",{"type":63,"coordinates":327},[328,329],0.20251,48.0021,{"lat":329,"lon":328},{"facility":332,"status":101,"city":304,"state":34,"zip":333,"country":285,"countryCode":286,"cosmosGeoPoint":334,"geoPoint":336,"contacts":34},"GH Diaconesses Croix Saint-Simon \u002FID# 269329","75020",{"type":63,"coordinates":335},[308,309],{"lat":309,"lon":308},{"facility":338,"status":101,"city":339,"state":34,"zip":340,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":34},"Mater Misericordiae University Hospital \u002FID# 269334","Dublin","D07 R2WY","Ireland","IE",{"type":63,"coordinates":344},[345,346],-6.24889,53.33306,{"lat":346,"lon":345},{"facility":349,"status":70,"city":339,"state":34,"zip":350,"country":341,"countryCode":342,"cosmosGeoPoint":351,"geoPoint":353,"contacts":34},"Beaumont Hospital \u002FID# 268864","D09 XR63",{"type":63,"coordinates":352},[345,346],{"lat":346,"lon":345},{"facility":355,"status":101,"city":356,"state":357,"zip":358,"country":359,"countryCode":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":34},"Hospital San Pedro de Alcántara \u002FID# 269320","Cáceres","Caceres","10003","Spain","ES",{"type":63,"coordinates":362},[363,364],-6.37224,39.47649,{"lat":364,"lon":363},{"facility":367,"status":101,"city":368,"state":369,"zip":370,"country":359,"countryCode":360,"cosmosGeoPoint":371,"geoPoint":375,"contacts":34},"Hospital Universitario de Jaén \u002FID# 269319","Jaén","Jaen","23007",{"type":63,"coordinates":372},[373,374],-3.79028,37.76922,{"lat":374,"lon":373},{"facility":377,"status":101,"city":378,"state":34,"zip":379,"country":359,"countryCode":360,"cosmosGeoPoint":380,"geoPoint":384,"contacts":34},"Usp Instituto Universitario Dexeus \u002FID# 269322","Barcelona","08028",{"type":63,"coordinates":381},[382,383],2.15899,41.38879,{"lat":383,"lon":382},{"facility":386,"status":101,"city":378,"state":34,"zip":387,"country":359,"countryCode":360,"cosmosGeoPoint":388,"geoPoint":390,"contacts":34},"Hospital Universitario Vall de Hebron \u002FID# 269315","08035",{"type":63,"coordinates":389},[382,383],{"lat":383,"lon":382},{"facility":392,"status":101,"city":393,"state":34,"zip":394,"country":359,"countryCode":360,"cosmosGeoPoint":395,"geoPoint":399,"contacts":34},"Hospital Universitario Ramon y Cajal \u002FID# 269318","Madrid","28034",{"type":63,"coordinates":396},[397,398],-3.70256,40.4165,{"lat":398,"lon":397},{"facility":401,"status":101,"city":393,"state":34,"zip":402,"country":359,"countryCode":360,"cosmosGeoPoint":403,"geoPoint":405,"contacts":34},"Hospital Universitario 12 de Octubre \u002FID# 269321","28041",{"type":63,"coordinates":404},[397,398],{"lat":398,"lon":397},{"facility":407,"status":101,"city":393,"state":34,"zip":408,"country":359,"countryCode":360,"cosmosGeoPoint":409,"geoPoint":411,"contacts":34},"Hospital Universitario La Paz \u002FID# 269302","28046",{"type":63,"coordinates":410},[397,398],{"lat":398,"lon":397},{"facility":413,"status":70,"city":414,"state":34,"zip":415,"country":359,"countryCode":360,"cosmosGeoPoint":416,"geoPoint":420,"contacts":34},"Hospital Universitario y Politecnico La Fe \u002FID# 269325","Valencia","46026",{"type":63,"coordinates":417},[418,419],-0.37966,39.47391,{"lat":419,"lon":418},{"type":422,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100544205","phase-2-a-study-of-ocular-toxicity-evaluation-and-mitigation-during-treatment-with-mirvetuximab-soravtansine-in-participants-with-recurrent-ovarian-cancer-with-high-folate-receptor-alpha-expression-100544205",false,"NCT06365853","A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression","A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRα expression.\n* Participant's tumor must be FRα positive (FRα high) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane staining intensity).\n* Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).\n* Participants must have completed prior therapy within the specified times below:\n\n  1. Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) before first dose of MIRV;\n  2. Focal radiation completed ≥ 2 weeks before the first dose of MIRV.\n* Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).\n* Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days before the first dose of MIRV.\n\nExclusion Criteria:\n\n* Participants with borderline ovarian tumor or non-epithelial histology or mixed histology including borderline or non-epithelial histology will be excluded.\n* PROC participants with primary platinum-refractory disease, defined as disease that did not respond to (complete response \\[CR\\] or partial response \\[PR\\]) or progressed within ≤ 3 months of the last dose of first line platinum-containing chemotherapy.\n* Participants with \\> Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).\n* Participants with significant active or chronic corneal disorders (for example, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (for example, active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment ≤ 90 days before first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20\u002F70 in either eye, or monocular vision.\n* Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1.\n* Participants who received prior treatment with MIRV or other FRα-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.","FEMALE","18 Years",{"count":433,"type":434},100,"ESTIMATED","INTERVENTIONAL",[437],"PHASE2","The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \\[PSOC\\] or platinum-resistant ovarian cancer \\[PROC\\]) with high folate receptor alpha (FRα) expression.",[440,441],"Recurrent Ovarian Cancer","Folate Receptor-Alpha Positive","2026-06-10",{"date":444,"type":445},"2026-06-12","ACTUAL",{"date":447,"type":445},"2024-07-29",{"date":449,"type":434},"2027-06",{"name":5,"class":6},40]