Ovarian Cancer Clinical Trial
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
Summary
The purpose of this study is to evaluate the incidence rate and severity of pre-specified 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.
Full 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).
Eligibility Criteria
Key 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 folate receptor 1 (FOLR1) (FOLR1-2.1) CDX Assay or Ventana FOLR1 (FOLR1-2.1) RxDx Assay (hereafter collectively termed: Ventana FOLR1 Assay) (≥75% cells exhibit 2 or 3+ 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:
Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV;
Focal radiation completed ≥ 2 weeks prior to the first dose of MIRV.
Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days prior to the first dose of MIRV.
Key Exclusion Criteria:
Participants with borderline ovarian tumor or non-epithelial histology or mixed histology including borderline or non-epithelial histology will be excluded.
PROC participants with primary platinum-refractory disease, defined as disease that did not respond to (complete response [CR] or partial response [PR]) or progressed ≤ 3 months of the last dose of first line platinum-containing chemotherapy.
Participants with > Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
Participants with significant active or chronic corneal disorders (for example, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (for example, active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment ≤ 90 days prior to first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70, or monocular vision.
Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1.
Participants who received prior treatment with MIRV or other FRα-targeting agents.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 8 Locations for this study
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Silver Spring Maryland, 20910, United States
Springfield Massachusetts, 01107, United States
Albany New York, 12208, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Dallas Texas, 75235, United States
Clayton Victoria, , Australia
Edegem Antwerp, , Belgium
Gent East Flanders, , Belgium
Gent East Flanders, , Belgium
Montreal Quebec, , Canada
Montreal Quebec, , Canada
Paris , , France
Paris , , France
Pierre Benite , , France
Dublin , , Ireland
Dublin , , Ireland
Milan , , Italy
Badalona Barcelona, , Spain
Barcelona , , Spain
Barcelona , , Spain
Jaen , , Spain
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.