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
NCT ID: NCT06365853
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2024-07-29
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Prednisolone acetate ophthalmic suspension 1% eye drops
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
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.
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.
Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Brimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.
Interventions
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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.
Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Prednisolone acetate ophthalmic suspension 1% eye drops
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
Brimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of California Los Angeles /ID# 269339
Los Angeles, California, United States
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky, United States
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland, United States
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri, United States
The Center Of Hope /ID# 269348
Reno, Nevada, United States
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York, United States
Women'S Cancer Care Associates /ID# 269980
Albany, New York, United States
Duke Cancer Institute /ID# 269342
Durham, North Carolina, United States
Summa Health /ID# 269349
Akron, Ohio, United States
UT Southwestern Medical Center /ID# 269341
Dallas, Texas, United States
Memorial Hermann Southeast Hospital /ID# 269347
Houston, Texas, United States
Blacktown Hospital /ID# 269305
Blacktown, New South Wales, Australia
Newcastle Private Hosptial /ID# 269306
Lambton Heights, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 269304
Clayton, Victoria, Australia
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem, Antwerpen, Belgium
OLV Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen, Belgium
AZ Sint-Lucas /ID# 269307
Ghent, Oost-Vlaanderen, Belgium
UZ Gent /ID# 269309
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven /ID# 269308
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 269312
Liège, , Belgium
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
Montreal, Quebec, Canada
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 269314
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site. /ID# 269313
Montreal, Quebec, Canada
Institut Paoli-Calmettes /ID# 269648
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours, Indre-et-Loire, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris, Paris, France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre-Bénite, Rhone, France
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans, Sarthe, France
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris, , France
Mater Misericordiae University Hospital /ID# 269334
Dublin, , Ireland
Beaumont Hospital /ID# 268864
Dublin, , Ireland
Hospital San Pedro de Alcántara /ID# 269320
Cáceres, Caceres, Spain
Hospital Universitario de Jaén /ID# 269319
Jaén, Jaen, Spain
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona, , Spain
Hospital Universitario Vall de Hebron /ID# 269315
Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 269321
Madrid, , Spain
Hospital Universitario La Paz /ID# 269302
Madrid, , Spain
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia, , Spain
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2023-505617-24-00
Identifier Type: OTHER
Identifier Source: secondary_id
IMGN853-0424
Identifier Type: -
Identifier Source: org_study_id