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RECRUITING

NCT06365853

PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-07-29

Completion Date

2027-06

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Recurrent Ovarian Cancer Folate Receptor-Alpha Positive

Interventions

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.

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.

DRUG

Brimonidine tartrate ophthalmic solution eye drops

Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

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.

Locations (40)

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

Universitair Ziekenhuis 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

Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (40)