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
- Conditions
- Recurrent Ovarian CancerFolate Receptor-Alpha Positive
- Registration Number
- NCT06365853
- Lead Sponsor
- ImmunoGen, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube,<br> and primary peritoneal cancer (EOC) with high FRa expression.<br><br> - Participant's tumor must be FRa positive (FRa high) as defined by either the Ventana<br> folate receptor 1 (FOLR1) (FOLR1-2.1) CDx Assay or FOLR1-2.1 RxDx Assay (hereafter<br> collectively termed: Ventana FOLR1 Assay) (=75% cells exhibit 2 or 3+<br> membrane-staining intensity).<br><br> - Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or<br> germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).<br><br> - Participants must have completed prior therapy within the specified times below:<br><br> 1. Systemic antineoplastic therapy = 5 half-lives or 4 weeks (whichever is<br> shorter) before first dose of MIRV;<br><br> 2. Focal radiation completed = 2 weeks before the first dose of MIRV.<br><br> - Participants must have stabilized or recovered (Grade 1 or baseline) from all prior<br> therapy-related toxicities (except alopecia).<br><br> - Women of childbearing potential (WOCBP) must agree to use highly effective<br> contraceptive method(s) while on MIRV and for = 7 months after the last dose; and<br> must have a negative pregnancy test = 4 days before the first dose of MIRV.<br><br>Key Exclusion Criteria:<br><br> - Participants with borderline ovarian tumor or non-epithelial histology or mixed<br> histology including borderline or non-epithelial histology will be excluded.<br><br> - PROC participants with primary platinum-refractory disease, defined as disease that<br> did not respond to (complete response [CR] or partial response [PR]) or progressed<br> within = 3 months of the last dose of first line platinum-containing chemotherapy.<br><br> - Participants with > Grade 1 peripheral neuropathy per National Cancer<br> Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE<br> v5.0).<br><br> - Participants with significant active or chronic corneal disorders (for example,<br> corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal<br> transplantation, significant ocular inflammatory conditions (for example, active or<br> recurrent uveitis), or other active ocular conditions requiring ongoing<br> treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy<br> with macular edema, macular degeneration requiring treatment = 90 days before first<br> dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70<br> in either eye, or monocular vision.<br><br> - Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or<br> within 5 weeks of Cycle 1 Day 1.<br><br> - Participants who received prior treatment with MIRV or other FRa-targeting agents.<br><br>Note: Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With MIRV-related Corneal AEs (= Grade 2) in Asymptomatic Participants
- Secondary Outcome Measures
Name Time Method Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis;Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants;Number of Participants With MIRV-related Corneal AEs (= Grade 2) and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis;National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score;Area Under the Curve (AUC) of MIRV;Maximum Serum Concentration (Cmax) of MIRV;Trough Concentration (Ctrough) of MIRV