NCT06365853

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Recurrent Ovarian Cancer
• Folate Receptor-Alpha Positive

Interventions

Type	Name	Description
DRUG	Mirvetuximab Soravtansine	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.
DRUG	Lubricating Eye Drops	Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
DRUG	Prednisolone acetate ophthalmic suspension 1% eye drops	Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
DRUG	Brimonidine tartrate ophthalmic solution eye drops	Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Timeline

• Start date: 2024-07-29
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-04-15
• Last updated: 2026-03-25

Locations

40 sites across 7 countries: United States, Australia, Belgium, Canada, France, Ireland, Spain

Regulatory

• FDA-regulated drug study