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Evaluating eye toxicity and prevention strategies during treatment for ovarian cancer

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

PHASE2 · AbbVie · NCT06365853

This study is testing different eye drop treatments to see if they can help prevent eye problems in women with recurrent ovarian cancer who are being treated with a specific medication.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie (industry)
Drugs / interventionschemotherapy, radiation, mirvetuximab
Locations40 sites (Los Angeles, California and 39 other locations)
Trial IDNCT06365853 on ClinicalTrials.gov

What this trial studies

This study aims to assess the incidence and severity of ocular adverse events related to the treatment with mirvetuximab soravtansine in patients with recurrent ovarian cancer that express high levels of folate receptor-alpha. Participants will be randomized into two groups to receive different prophylactic eye drop treatments to mitigate these adverse events. The study will include both symptomatic and asymptomatic patients undergoing regular ophthalmic evaluations. The goal is to identify effective strategies to prevent ocular toxicity during treatment.

Who should consider this trial

Good fit: Ideal candidates are patients with recurrent ovarian cancer who have high folate receptor-alpha expression and have completed prior therapies.

Not a fit: Patients with low folate receptor-alpha expression or those who have not completed prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of ocular side effects in patients receiving treatment for recurrent ovarian cancer.

How similar studies have performed: Other studies have shown success in managing treatment-related ocular adverse events, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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. Focal radiation completed ≥ 2 weeks before 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 before the first dose of MIRV.

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 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.
* Participants who received prior treatment with MIRV or other FRα-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.