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

Conditions

Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression

Brief summary

The incidence rate and severity of MIRV-related corneal TEAEs (≥ Grade 2) in asymptomatic patients (defined as ocular symptom assessment ≤ Grade 1) with recurrent ovarian cancer with high FRα expression, assessed up to 18 weeks from Cycle 1 Day 1 (C1D1) or at the 30-Day Follow-up visit, whichever is earlier

Detailed description

The incidence rate and severity of ocular symptom TEAEs in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of MIRV-related corneal TEAEs (≥ Grade 2) in symptomatic patients on ophthalmic assessment up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of all MIRV-related corneal TEAEs (≥ Grade 2) in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up, whichever is earlier, Use of the composite score of the NEI VFQ-25 to evaluate ocular HRQoL and patient-reported outcomes at C5D1 or at the 30-Day Follow-up visit, whichever is earlier, PK concentrations, including pre-dose and end-of-infusion plasma concentration in asymptomatic and symptomatic patients in both prophylaxis groups, The incidence rate and severity of ocular exam TEAEs in asymptomatic and symptomatic patients on ophthalmic assessment up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of ocular exam TEAEs in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis up to 18 weeks from C1D1 or at the 30‑Day Follow-up visit, whichever is earlier

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Interventions

DRUGAlphagan 2 mg/ml colirio en solución

DRUGPred Forte 10 mg/ml colirio en suspensión

DRUGMirvetuximab Soravtansine

DRUGBrimonidine Tartrate 0.2% w/v Eye Drops.

DRUGPred Forte 1% w/v

DRUGEye Drops Suspension

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The incidence rate and severity of MIRV-related corneal TEAEs (≥ Grade 2) in asymptomatic patients (defined as ocular symptom assessment ≤ Grade 1) with recurrent ovarian cancer with high FRα expression, assessed up to 18 weeks from Cycle 1 Day 1 (C1D1) or at the 30-Day Follow-up visit, whichever is earlier	—

Secondary

Measure	Time frame
The incidence rate and severity of ocular symptom TEAEs in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of MIRV-related corneal TEAEs (≥ Grade 2) in symptomatic patients on ophthalmic assessment up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of all MIRV-related corneal TEAEs (≥ Grade 2) in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up, whichever is earlier, Use of the composite score of the NEI VFQ-25 to evaluate ocular HRQoL and patient-reported outcomes at C5D1 or at the 30-Day Follow-up visit, whichever is earlier, PK concentrations, including pre-dose and end-of-infusion plasma concentration in asymptomatic and symptomatic patients in both prophylaxis groups, The incidenc	—

Measure

Time frame

The incidence rate and severity of ocular symptom TEAEs in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of MIRV-related corneal TEAEs (≥ Grade 2) in symptomatic patients on ophthalmic assessment up to 18 weeks from C1D1 or at the 30-Day Follow-up visit, whichever is earlier, The incidence rate and severity of all MIRV-related corneal TEAEs (≥ Grade 2) in patients using corticosteroid or vasoconstricting eye drop primary prophylaxis assessed up to 18 weeks from C1D1 or at the 30-Day Follow-up, whichever is earlier, Use of the composite score of the NEI VFQ-25 to evaluate ocular HRQoL and patient-reported outcomes at C5D1 or at the 30-Day Follow-up visit, whichever is earlier, PK concentrations, including pre-dose and end-of-infusion plasma concentration in asymptomatic and symptomatic patients in both prophylaxis groups, The incidenc

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Countries

Belgium, France, Ireland, Spain

Outcome results

None listed