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Can eye drops save sight during ovarian cancer treatment?

NCT ID NCT06365853

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether different eye drops can prevent or reduce eye problems caused by the cancer drug mirvetuximab soravtansine in 100 people with recurrent ovarian cancer. Participants will receive the cancer drug along with either lubricating drops, steroid drops, or drops that shrink blood vessels. The goal is to find the best way to protect eyesight during treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirvetuximab soravtansine (MIRV) with lubricating eye drops, corticosteroid eye drops, or brimonidine eye drops
What this could lead to
If successful, this study could identify a way to prevent or reduce eye problems caused by mirvetuximab soravtansine, making treatment safer and more tolerable for ovarian cancer patients.
What could go wrong
This is a small, early-phase study focused on side effects, not on curing cancer. The eye drop strategies may not work or could cause their own side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

108 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Folate receptor-alpha positive Recurrent ovarian cancer

Contacts and locations

Locations

  • AZ Sint-Lucas /ID# 269307

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Beaumont Hospital /ID# 268864

    Dublin, D09 XR63, Ireland

  • Blacktown Hospital /ID# 269305

    Blacktown, New South Wales, 2148, Australia

  • CHU de Liege /ID# 269312

    Liège, 4000, Belgium

  • Centre Hospitalier Regional Universitaire de Tours - Hopital Bretonneau /ID# 269301

    Tours, Indre-et-Loire, 37000, France

  • Centre Hospitalier de l'Universite de Montreal /ID# 269314

    Montreal, Quebec, H2X 0C1, Canada

  • Clinique Victor Hugo Le Mans /ID# 269985

    Le Mans, Sarthe, 72000, France

  • Duke Cancer Institute /ID# 269342

    Durham, North Carolina, 27710, United States

  • GH Diaconesses Croix Saint-Simon /ID# 269329

    Paris, 75020, France

  • Holy Cross Hospital - Silver Spring /ID# 269344

    Silver Spring, Maryland, 20910, United States

  • Holy Name Medical Center /ID# 269340

    Teaneck, New Jersey, 07666, United States

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330

    Paris, Paris, 75679, France

  • Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327

    Pierre-Bénite, Rhone, 69310, France

  • Hospital San Pedro de Alcantara /ID# 269320

    Cáceres, 10003, Spain

  • Hospital Universitario 12 de Octubre /ID# 269321

    Madrid, 28041, Spain

  • Hospital Universitario La Paz /ID# 269302

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal /ID# 269318

    Madrid, 28034, Spain

  • Hospital Universitario Vall de Hebron /ID# 269315

    Barcelona, 08035, Spain

  • Hospital Universitario de Jaen /ID# 269319

    Jaén, 23007, Spain

  • Hospital Universitario y Politecnico La Fe /ID# 269325

    Valencia, 46026, Spain

  • Institut Paoli-Calmettes /ID# 269648

    Marseille, Bouches-du-Rhone, 13273, France

  • Mater Misericordiae University Hospital /ID# 269334

    Dublin, D07 R2WY, Ireland

  • McGill University Health Centre - Glen Site /ID# 269313

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Hermann Southeast Hospital /ID# 269347

    Houston, Texas, 77089, United States

  • Mercy David C. Pratt Cancer Center /ID# 269350

    St Louis, Missouri, 63141, United States

  • Monash Health - Monash Medical Centre - Clayton /ID# 269304

    Clayton, Victoria, 3168, Australia

  • New York Oncology Hematology - Albany Cancer Center /ID# 269345

    Albany, New York, 12206-5013, United States

  • Newcastle Private Hosptial /ID# 269306

    Lambton Heights, New South Wales, 2305, Australia

  • Norton Cancer Institute - St. Matthews /ID# 269070

    Louisville, Kentucky, 40207, United States

  • OLV Ziekenhuis Aalst /ID# 269311

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • Summa Health /ID# 269349

    Akron, Ohio, 44304-1407, United States

  • The Center Of Hope /ID# 269348

    Reno, Nevada, 89511, United States

  • UCSF Medical Center /ID# 280425

    San Francisco, California, 94158-2531, United States

  • UZ Gent /ID# 269309

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitair Ziekenhuis Antwerpen /ID# 269310

    Edegem, Antwerpen, 2650, Belgium

  • Universitair Ziekenhuis Leuven /ID# 269308

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862

    Montreal, Quebec, H1T 2M4, Canada

  • University of California Los Angeles /ID# 269339

    Los Angeles, California, 90095, United States

  • University of Texas - Southwestern Medical Center /ID# 269341

    Dallas, Texas, 75235, United States

  • Usp Instituto Universitario Dexeus /ID# 269322

    Barcelona, 08028, Spain

  • Women'S Cancer Care Associates /ID# 269980

    Albany, New York, 12208, United States

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