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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants — 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 .
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
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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 Spain