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Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W). Each cycle length = 21 days.

Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) throughout the cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W. Each cycle length = 21 days.

Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Mirvetuximab Soravtansine

Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.

Lubricating Eye Drops

Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.

Prednisolone acetate ophthalmic suspension 1% eye drops

Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Brimonidine tartrate ophthalmic solution eye drops

ImmunoGen, Inc.

Sheri Spunt, MD

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.

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).

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

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

This endpoint will be assessed in the participants receiving MIRV who are asymptomatic (defined as ocular symptom assessment ≤ Grade 1), in the 3-week period prior to the examination.

Spots Global Cancer Trial Database for lubricating eye drops