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.
Official Title
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
Details
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).
Keywords
Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Toxic Optic Neuropathy, Recurrence, Prednisolone, Methylprednisolone Acetate, Methylprednisolone, Methylprednisolone Hemisuccinate, Prednisolone acetate, Maytansine, Brimonidine Tartrate, Ophthalmic Solutions, Lubricant Eye Drops, Prednisolone hemisuccinate, Prednisolone phosphate, Mirvetuximab soravtansine, Lubricating Eye Drops, Prednisolone acetate ophthalmic suspension 1% eye drops, Brimonidine tartrate ophthalmic solution eye drops