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
Start Date
7/29/2024
Completion Date
6/1/2027
Summary
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.
Detailed Description
Participants will be randomized (1:1) to 1 of 2 ocular adverse event (AE) risk mitigation strategy arms (primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Mirvetuximab Soravtansine
Lubricating Eye Drops
Prednisolone acetate ophthalmic suspension 1% eye drops
Brimonidine tartrate ophthalmic solution eye drops
Conditions
Locations
University of California Los Angeles /ID# 269339
Los Angeles, California 90095
United States
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky 40207
United States
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland 20910
United States
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri 63141
United States
The Center Of Hope /ID# 269348
Reno, Nevada 89511
United States
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey 07666
United States
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York 12206-5013
United States
Women'S Cancer Care Associates /ID# 269980
Albany, New York 12208
United States
Duke Cancer Institute /ID# 269342
Durham, North Carolina 27710
United States
Summa Health /ID# 269349
Akron, Ohio 44304-1407
United States
UT Southwestern Medical Center /ID# 269341
Dallas, Texas 75390
United States
Memorial Hermann Southeast Hospital /ID# 269347
Houston, Texas 77089
United States
Blacktown Hospital /ID# 269305
Blacktown, New South Wales 2148
Australia
Newcastle Private Hosptial /ID# 269306
Lambton Heights, New South Wales 2305
Australia
Monash Health - Monash Medical Centre - Clayton /ID# 269304
Clayton, Victoria 3168
Australia
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem, Antwerpen 2650
Belgium
OLV Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen 9300
Belgium
AZ Sint-Lucas /ID# 269307
Ghent, Oost-Vlaanderen 9000
Belgium
UZ Gent /ID# 269309
Ghent, Oost-Vlaanderen 9000
Belgium
Universitair Ziekenhuis Leuven /ID# 269308
Leuven, Vlaams-Brabant 3000
Belgium
CHU de Liege /ID# 269312
Liège, 4000
Belgium
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
Montreal, Quebec H1T 2M4
Canada
Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314
Montreal, Quebec H2L 4M1
Canada
McGill University Health Centre - Glen Site. /ID# 269313
Montreal, Quebec H4A 3J1
Canada
Institut Paoli-Calmettes /ID# 269648
Marseille, Bouches-du-Rhone 13273
France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours, Indre-et-Loire 37000
France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris, Paris 75679
France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre-Bénite, Rhone 69310
France
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans, Sarthe 72000
France
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris, 75020
France
Mater Misericordiae University Hospital /ID# 269334
Dublin, D07 R2WY
Ireland
Beaumont Hospital /ID# 268864
Dublin, D09 XR63
Ireland
Hospital San Pedro de Alcántara /ID# 269320
Cáceres, Caceres 10003
Spain
Hospital Universitario de Jaén /ID# 269319
Jaén, Jaen 23007
Spain
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona, 08028
Spain
Hospital Universitario Vall de Hebron /ID# 269315
Barcelona, 08035
Spain
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre /ID# 269321
Madrid, 28041
Spain
Hospital Universitario La Paz /ID# 269302
Madrid, 28046
Spain
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia, 46026
Spain