What is mirvetuximab soravtansine studying for recurrent ovarian cancer?

Mirvetuximab soravtansine is being studied to understand its eye-related side effects in women with recurrent ovarian cancer that has high folate receptor alpha expression. This trial compares two eye drop strategies to reduce these side effects. The research is sponsored by AbbVie to improve treatment safety for this condition.

Who may be eligible for this recurrent ovarian cancer clinical trial?

Women aged 18 or older with confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses high folate receptor alpha may be eligible. Participants should have completed prior therapies and have no significant eye disorders or current use of related eye drops. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent ovarian cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

FEMALE

ID06365853

Evaluating Eye Side Effect Prevention With Mirvetuximab Soravtansine in Women With Recurrent Ovarian Cancer Having High Folate Receptor-Alpha

Led by AbbVie · Updated on 2026-06-12

100

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the rate and severity of eye-related side effects caused by mirvetuximab soravtansine MIRV in women with recurrent ovarian cancer that expresses high levels of folate receptor alpha. The study compares two strategies to prevent these eye side effects by randomly assigning participants to receive either steroid eye drops or vasoconstricting eye drops as primary prophylaxis. Participants include those with platinum-sensitive or platinum-resistant ovarian cancer who have undergone prior therapies and meet specific safety and recovery criteria. Participants will be randomly placed into one of two groups. One group will use prednisolone acetate steroid eye drops six times daily initially, then four times daily, along with lubricating eye drops throughout each 21-day treatment cycle. The other group will use brimonidine tartrate vasoconstricting eye drops three times daily plus lubricating drops on the same schedule. All participants receive MIRV intravenously at a dose of 6 mg per kilogram of adjusted ideal body weight on the first day of each 21-day cycle. The study treatment continues for up to 18 weeks or through five cycles, followed by a 30-day follow-up. Throughout the study, participants undergo regular eye examinations to monitor for treatment-emergent adverse events and complete questionnaires measuring visual function. Blood samples are collected to analyze MIRV drug levels. The main outcome is the number of participants experiencing moderate or worse corneal side effects during treatment. Secondary outcomes include other eye-related symptoms and drug concentration measures. Safety and adherence to the eye drop schedules are carefully tracked during the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Women with confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer exhibiting high folate receptor alpha expression
Tumor must be folate receptor alpha positive as defined by VENTANA FOLR1 Assay with at least 75% of cells showing moderate to strong staining
Participants with known BRCA mutations must have received PARP inhibitors
Completed prior systemic antineoplastic therapy at least 4 weeks or 5 half-lives before first MIRV dose
Completed focal radiation therapy at least 2 weeks before first MIRV dose
Stabilized or recovered to Grade 1 or baseline from prior therapy toxicities except alopecia
Women of childbearing potential must use highly effective contraception during and for 7 months after MIRV treatment and have a negative pregnancy test within 4 days before first dose

You will not qualify if you...

Borderline ovarian tumor, non-epithelial, or mixed histology including these types
Platinum-refractory disease in platinum-resistant ovarian cancer defined as no response or progression within 3 months of last platinum chemotherapy
Peripheral neuropathy greater than Grade 1 per NCI-CTCAE v5.0
Significant active or chronic corneal disorders, history of corneal transplant, or significant ocular inflammatory conditions
Other active eye diseases requiring ongoing treatment such as uncontrolled glaucoma or active diabetic retinopathy with macular edema
Best corrected visual acuity worse than 20/70 in either eye or monocular vision
Use of corticosteroid or vasoconstricting eye drops at baseline or within 5 weeks before first MIRV dose
Prior treatment with MIRV or other folate receptor alpha targeting agents

Research Team

ABBVIE CALL CENTER

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Evaluating Eye Side Effect Prevention With Mirvetuximab Soravtansine in Women With Recurrent Ovarian Cancer Having High Folate Receptor-Alpha

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria