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