A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab So
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 recurr
| Condition(s) | Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRα expression. * Participant's tumor must be FRα positive (FRα high) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane staining intensity). * Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi). * Participants must have completed prior therapy within the specified times below: 1. Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) before first dose of MIRV; 2. Fo |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | AbbVie |
| Locations | Los Angeles, California, United States; Louisville, Kentucky, United States; Silver Spring, Maryland, United States; St Louis, Missouri, United States; Reno, Nevada, United States; Teaneck, New Jersey, United States (+34 more sites) |
| Start date | 2024-07-29 |
| NCT ID | NCT06365853 |
| Official listing | https://clinicaltrials.gov/study/NCT06365853 |