protocolSection identificationModule nctId: NCT06365853, orgStudyIdInfo id: IMGN853-0424, secondaryIdInfos id: 2023-505617-24-00, type: CTIS, briefTitle: 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-05-26, completionDateStruct date: 2027-05-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ImmunoGen, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the incidence rate and severity of pre-specified 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., conditionsModule conditions: Recurrent Ovarian Cancer, conditions: Folate Receptor-Alpha Positive, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mirvetuximab Soravtansine, interventions name: Lubricating Eye Drops, interventions name: Prednisolone acetate ophthalmic suspension 1% eye drops, interventions name: Brimonidine tartrate ophthalmic solution eye drops, outcomesModule primaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants, secondaryOutcomes measure: Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis, secondaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants, secondaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis, secondaryOutcomes measure: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score, secondaryOutcomes measure: Area Under the Curve (AUC) of MIRV, secondaryOutcomes measure: Maximum Serum Concentration (Cmax) of MIRV, secondaryOutcomes measure: Trough Concentration (Ctrough) of MIRV, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP), city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Yale School of Medicine - Yale Gynecologic Oncology, city: New Haven, state: Connecticut, zip: 06510, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Holy Cross Hospital, city: Silver Spring, state: Maryland, zip: 20910, country: United States, geoPoint lat: 38.99067, lon: -77.02609, locations facility: Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology, city: Springfield, state: Massachusetts, zip: 01107, country: United States, geoPoint lat: 42.10148, lon: -72.58981, locations facility: New York Oncology Hematology, city: Albany, state: New York, zip: 12208, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Women's Cancer Care Associates, LLC, city: Albany, state: New York, zip: 12208, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke Cancer Institute (DCI) - Duke Cancer Center, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, locations facility: University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic, city: Dallas, state: Texas, zip: 75235, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Monash University - Monash Medical Centre (MMC) - Clayton, city: Clayton, state: Victoria, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek, city: Edegem, state: Antwerp, country: Belgium, geoPoint lat: 51.15662, lon: 4.44504, locations facility: AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek, city: Gent, state: East Flanders, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: Universitair Ziekenhuis Gent (UZ Gent), city: Gent, state: East Flanders, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre, city: Montreal, state: Quebec, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, city: Montreal, state: Quebec, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud, city: Pierre Benite, country: France, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Bon Secours Hospital - Dublin, city: Dublin, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Mater Misericordiae University Hospital (MMUH) (START Dublin), city: Dublin, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Istituto Europeo di Oncologia (IEO) (European Institute of Oncology), city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location, city: Badalona, state: Barcelona, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Parc Taulí, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Vall d'Hebron Institut d'Oncologia, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen), city: Jaen, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False