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

March 23, 2026 updated by: AbbVie

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

The purpose of this study is to evaluate the incidence rate and severity of prespecified 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Active, not recruiting
        • Blacktown Hospital /ID# 269305
      • Lambton Heights, New South Wales, Australia, 2305
        • Active, not recruiting
        • Newcastle Private Hosptial /ID# 269306
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Active, not recruiting
        • Monash Health - Monash Medical Centre /ID# 269304
  • Belgium
      • Liège, Belgium, 4000
        • Completed
        • CHU de Liege /ID# 269312
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Completed
        • Universitair Ziekenhuis Antwerpen /ID# 269310
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • Active, not recruiting
        • OLV Ziekenhuis Aalst /ID# 269311
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Active, not recruiting
        • AZ Sint-Lucas /ID# 269307
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Completed
        • UZ Gent /ID# 269309
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Active, not recruiting
        • Universitair Ziekenhuis Leuven /ID# 269308
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Active, not recruiting
        • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
      • Montreal, Quebec, Canada, H4A 3J1
        • Active, not recruiting
        • McGill University Health Centre - Glen Site. /ID# 269313
      • Montreal, Quebec, Canada, H2L 4M1
        • Active, not recruiting
        • Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314
  • France
      • Paris, France, 75020
        • Active, not recruiting
        • GH Diaconesses Croix Saint-Simon /ID# 269329
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13273
        • Active, not recruiting
        • Institut Paoli-Calmettes /ID# 269648
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Active, not recruiting
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
    • Paris
      • Paris, Paris, France, 75679
        • Active, not recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Active, not recruiting
        • Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
    • Sarthe
      • Le Mans, Sarthe, France, 72000
        • Active, not recruiting
        • Clinique Victor Hugo Le Mans /ID# 269985
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Active, not recruiting
        • Mater Misericordiae University Hospital /ID# 269334
      • Dublin, Ireland, D09 XR63
        • Completed
        • Beaumont Hospital /ID# 268864
  • Spain
      • Barcelona, Spain, 08028
        • Active, not recruiting
        • Usp Instituto Universitario Dexeus /ID# 269322
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitario Vall de Hebron /ID# 269315
      • Madrid, Spain, 28034
        • Active, not recruiting
        • Hospital Universitario Ramon y Cajal /ID# 269318
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre /ID# 269321
      • Madrid, Spain, 28046
        • Active, not recruiting
        • Hospital Universitario La Paz /ID# 269302
      • Valencia, Spain, 46026
        • Completed
        • Hospital Universitario y Politecnico La Fe /ID# 269325
    • Caceres
      • Cáceres, Caceres, Spain, 10003
        • Active, not recruiting
        • Hospital San Pedro de Alcántara /ID# 269320
    • Jaen
      • Jaén, Jaen, Spain, 23007
        • Active, not recruiting
        • Hospital Universitario de Jaén /ID# 269319
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles /ID# 269339
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Completed
        • Norton Cancer Institute - St. Matthews /ID# 269070
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital - Silver Spring /ID# 269344
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy David C. Pratt Cancer Center /ID# 269350
    • Nevada
      • Reno, Nevada, United States, 89511
        • Active, not recruiting
        • The Center Of Hope /ID# 269348
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center /ID# 269340
    • New York
      • Albany, New York, United States, 12208
        • Completed
        • Women'S Cancer Care Associates /ID# 269980
      • Albany, New York, United States, 12206-5013
        • Completed
        • New York Oncology Hematology - Albany Cancer Center /ID# 269345
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute /ID# 269342
    • Ohio
      • Akron, Ohio, United States, 44304-1407
        • Recruiting
        • Summa Health /ID# 269349
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center /ID# 269341
      • Houston, Texas, United States, 77089
        • Recruiting
        • Memorial Hermann Southeast Hospital /ID# 269347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Prophylactic Steroid Eye Drops
Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days.
Drug: Mirvetuximab Soravtansine
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Other Names:
  • IMGN853
  • MIRV
Drug: Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Drug: Prednisolone acetate ophthalmic suspension 1% eye drops
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
Experimental: Primary Prophylactic Vasoconstricting Eye Drops
Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days.
Drug: Mirvetuximab Soravtansine
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Other Names:
  • IMGN853
  • MIRV
Drug: Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Drug: Brimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants
Time Frame: Cycle 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 .
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score
Time Frame: At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Area Under the Curve (AUC) of MIRV
Time Frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Maximum Serum Concentration (Cmax) of MIRV
Time Frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Trough Concentration (Ctrough) of MIRV
Time Frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Number of Participants With Ocular symptom TEAEs in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis
Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days
Number of Participants With MIRV-related Corneal TEAEs in Symptomatic Participants
Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Number of Participants With Ocular exam TEAEs in Asymptomatic Participants and Symptomatic participants
Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis
Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Number of Participants with ocular exam TEAEs in Participants using corticosteroid or vasoconstricting eye drop primary prophylaxis
Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN853-0424
  • 2023-505617-24-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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