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

Study Identifier
IMGN853-0424
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-505617-24-00
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Study Details

Medical Condition
  • Ovarian Cancer
  • Cancer - Other
  • Study Drug
  • Mirvetuximab Soravtansine
  • Lubricating Eye Drops
  • Prednisolone acetate ophthalmic suspension 1% eye drops
  • Brimonidine tartrate ophthalmic solution eye drops
  • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    University of California Los Angeles /ID# 269339
    Los Angeles, California, United States, 90095
    Status
    Recruiting
    Location
    Norton Cancer Institute - St. Matthews /ID# 269070
    Louisville, Kentucky, United States, 40207
    Status
    Completed
    Location
    Holy Cross Hospital - Silver Spring /ID# 269344
    Silver Spring, Maryland, United States, 20910
    Status
    Recruiting
    Location
    Mercy David C. Pratt Cancer Center /ID# 269350
    St Louis, Missouri, United States, 63141
    Status
    Recruiting
    Location
    The Center Of Hope /ID# 269348
    Reno, Nevada, United States, 89511
    Status
    Active, Not Recruiting
    Location
    Holy Name Medical Center /ID# 269340
    Teaneck, New Jersey, United States, 07666
    Status
    Recruiting
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