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Study of Mirvetuximab Soravtansine for Recurrent Ovarian Cancer with Ocular Toxicity Mitigation

This study is for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer that has high levels of a protein called folate receptor-alpha (FRα). You must have a confirmed diagnosis of this type of cancer with high FRα expression. The study is testing a drug called mirvetuximab soravtansine, which targets FRα. A common side effect of mirvetuximab soravtansine can be eye problems. This study aims to see how often these eye problems occur and to compare two different ways to prevent them: using prednisolone acetate ophthalmic suspension 1% eye drops or brimonidine tartrate ophthalmic solution eye drops. Lubricating eye drops will also be used. The main goal is to measure the number of participants who experience moderate to severe eye-related side effects from mirvetuximab soravtansine.

Study design
This is an interventional study planning to enroll 100 participants. You will be randomly assigned to one of two groups, each receiving a different eye drop strategy to prevent side effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 18 weeks or at the 30-day follow-up visit, whichever is earlier.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~108 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Mirvetuximab SoravtansineLubricating Eye DropsPrednisolone acetate ophthalmic suspension 1% eye dropsBrimonidine tartrate ophthalmic solution eye drops

At a glance

Recruiting sites
0 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants
Measured over Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Conditions

Recurrent Ovarian Cancer
Folate Receptor-Alpha Positive

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerFRα

Where it's being run

41 sites across 25 states
Spain8
Oost-Vlaanderen3
Quebec3
California2
New York2
Texas2
New South Wales2
Ireland2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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 before the first dose of MIRV.

Exclusion

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 within ≤ 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 before first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70 in either eye, or monocular vision.
Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1.

What this trial measures

  • Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic ParticipantsCycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

    This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .