drugset / Trial / 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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-29
- Primary completion
- 2026-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brimonidine | Small molecule | — | Other |
| Subject | Mirvetuximab Soravtansine | Other / unclassified | 6 mg/kg | — |
| Subject | Prednisolone | Other / unclassified | 1 % | Other |