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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 · AbbVie
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Official title
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
About this study
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).
Eligibility criteria
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 design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-29
Estimated completion: 2027-06
Last updated: 2026-03-25
Interventions
Drug: Mirvetuximab SoravtansineDrug: Lubricating Eye DropsDrug: Prednisolone acetate ophthalmic suspension 1% eye dropsDrug: Brimonidine tartrate ophthalmic solution eye drops
Primary outcomes
  • 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))
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (40)
University of California Los Angeles /ID# 269339Recruiting
Los Angeles, California, United States
Norton Cancer Institute - St. Matthews /ID# 269070Completed
Louisville, Kentucky, United States
Holy Cross Hospital - Silver Spring /ID# 269344Recruiting
Silver Spring, Maryland, United States
Mercy David C. Pratt Cancer Center /ID# 269350Recruiting
St Louis, Missouri, United States
The Center Of Hope /ID# 269348Active Not Recruiting
Reno, Nevada, United States
Holy Name Medical Center /ID# 269340Recruiting
Teaneck, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 269345Completed
Albany, New York, United States
Women'S Cancer Care Associates /ID# 269980Completed
Albany, New York, United States
Duke Cancer Institute /ID# 269342Recruiting
Durham, North Carolina, United States
Summa Health /ID# 269349Recruiting
Akron, Ohio, United States
UT Southwestern Medical Center /ID# 269341Recruiting
Dallas, Texas, United States
Memorial Hermann Southeast Hospital /ID# 269347Recruiting
Houston, Texas, United States
Blacktown Hospital /ID# 269305Active Not Recruiting
Blacktown, New South Wales, Australia
Newcastle Private Hosptial /ID# 269306Active Not Recruiting
Lambton Heights, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 269304Active Not Recruiting
Clayton, Victoria, Australia
Universitair Ziekenhuis Antwerpen /ID# 269310Completed
Edegem, Antwerpen, Belgium
OLV Ziekenhuis Aalst /ID# 269311Active Not Recruiting
Aalst, Oost-Vlaanderen, Belgium
AZ Sint-Lucas /ID# 269307Active Not Recruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Gent /ID# 269309Completed
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 269308Active Not Recruiting
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 269312Completed
Liège, Belgium
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862Active Not Recruiting
Montreal, Quebec, Canada
Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314Active Not Recruiting
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site. /ID# 269313Active Not Recruiting
Montreal, Quebec, Canada
Institut Paoli-Calmettes /ID# 269648Active Not Recruiting
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301Active Not Recruiting
Tours, Indre-et-Loire, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330Active Not Recruiting
Paris, Paris, France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327Active Not Recruiting
Pierre-Bénite, Rhone, France
Clinique Victor Hugo Le Mans /ID# 269985Active Not Recruiting
Le Mans, Sarthe, France
GH Diaconesses Croix Saint-Simon /ID# 269329Active Not Recruiting
Paris, France
Mater Misericordiae University Hospital /ID# 269334Active Not Recruiting
Dublin, Ireland
Beaumont Hospital /ID# 268864Completed
Dublin, Ireland
Hospital San Pedro de Alcántara /ID# 269320Active Not Recruiting
Cáceres, Caceres, Spain
Hospital Universitario de Jaén /ID# 269319Active Not Recruiting
Jaén, Jaen, Spain
Usp Instituto Universitario Dexeus /ID# 269322Active Not Recruiting
Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 269315Active Not Recruiting
Barcelona, Spain
Hospital Universitario Ramon y Cajal /ID# 269318Active Not Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 269321Active Not Recruiting
Madrid, Spain
Hospital Universitario La Paz /ID# 269302Active Not Recruiting
Madrid, Spain
Hospital Universitario y Politecnico La Fe /ID# 269325Completed
Valencia, Spain
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 · TrialPath