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Clinical Trials in the USA / NCT06365853
Active, not recruiting Phase 2

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

NCT06365853 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2024-07-29
Last updated
2026-08-21

Condition(s) studied

Recurrent Ovarian CancerFolate Receptor-Alpha Positive

Investigational drug(s) / intervention(s)

Mirvetuximab SoravtansineLubricating Eye DropsPrednisolone acetate ophthalmic suspension 1% eye dropsBrimonidine tartrate ophthalmic solution eye drops

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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
University of California Los Angeles /ID# 269339 Los Angeles California
UCSF Medical Center /ID# 280425 San Francisco California
Norton Cancer Institute - St. Matthews /ID# 269070 Louisville Kentucky
Holy Cross Hospital - Silver Spring /ID# 269344 Silver Spring Maryland
Mercy David C. Pratt Cancer Center /ID# 269350 St Louis Missouri
The Center Of Hope /ID# 269348 Reno Nevada
Holy Name Medical Center /ID# 269340 Teaneck New Jersey
New York Oncology Hematology - Albany Cancer Center /ID# 269345 Albany New York
Women'S Cancer Care Associates /ID# 269980 Albany New York
Duke Cancer Institute /ID# 269342 Durham North Carolina
Summa Health /ID# 269349 Akron Ohio
University of Texas - Southwestern Medical Center /ID# 269341 Dallas Texas
Memorial Hermann Southeast Hospital /ID# 269347 Houston Texas
Blacktown Hospital /ID# 269305 Blacktown New South Wales
Newcastle Private Hosptial /ID# 269306 Lambton Heights New South Wales
Monash Health - Monash Medical Centre - Clayton /ID# 269304 Clayton Victoria
Universitair Ziekenhuis Antwerpen /ID# 269310 Edegem Antwerpen
OLV Ziekenhuis Aalst /ID# 269311 Aalst Oost-Vlaanderen
AZ Sint-Lucas /ID# 269307 Ghent Oost-Vlaanderen
UZ Gent /ID# 269309 Ghent Oost-Vlaanderen
Universitair Ziekenhuis Leuven /ID# 269308 Leuven Vlaams-Brabant
CHU de Liege /ID# 269312 Liège Belgium
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862 Montreal Quebec
Centre Hospitalier de l'Universite de Montreal /ID# 269314 Montreal Quebec
McGill University Health Centre - Glen Site /ID# 269313 Montreal Quebec
Institut Paoli-Calmettes /ID# 269648 Marseille Bouches-du-Rhone
Centre Hospitalier Regional Universitaire de Tours - Hopital Bretonneau /ID# 269301 Tours Indre-et-Loire
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330 Paris Paris
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327 Pierre-Bénite Rhone
Clinique Victor Hugo Le Mans /ID# 269985 Le Mans Sarthe
GH Diaconesses Croix Saint-Simon /ID# 269329 Paris France
Mater Misericordiae University Hospital /ID# 269334 Dublin Ireland
Beaumont Hospital /ID# 268864 Dublin Ireland
Usp Instituto Universitario Dexeus /ID# 269322 Barcelona Spain
Hospital Universitario Vall de Hebron /ID# 269315 Barcelona Spain
Hospital San Pedro de Alcantara /ID# 269320 Cáceres Spain
Hospital Universitario de Jaen /ID# 269319 Jaén 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

+ 1 more sites — see the full list on the official registry below.

More AbbVie trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06365853 on ClinicalTrials.gov ↗ ← All trials in the USA