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NCT06365853PHASE2Recruiting

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

AbbVie

Start Date

7/29/2024

Completion Date

6/1/2027

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.

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Mirvetuximab Soravtansine

DRUG

Lubricating Eye Drops

DRUG

Prednisolone acetate ophthalmic suspension 1% eye drops

DRUG

Brimonidine tartrate ophthalmic solution eye drops

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Conditions

Recurrent Ovarian CancerFolate Receptor-Alpha Positive

Locations

University of California Los Angeles /ID# 269339

Los Angeles, California 90095

United States

Norton Cancer Institute - St. Matthews /ID# 269070

Louisville, Kentucky 40207

United States

Holy Cross Hospital - Silver Spring /ID# 269344

Silver Spring, Maryland 20910

United States

Mercy David C. Pratt Cancer Center /ID# 269350

St Louis, Missouri 63141

United States

The Center Of Hope /ID# 269348

Reno, Nevada 89511

United States

Holy Name Medical Center /ID# 269340

Teaneck, New Jersey 07666

United States

New York Oncology Hematology - Albany Cancer Center /ID# 269345

Albany, New York 12206-5013

United States

Women'S Cancer Care Associates /ID# 269980

Albany, New York 12208

United States

Duke Cancer Institute /ID# 269342

Durham, North Carolina 27710

United States

Summa Health /ID# 269349

Akron, Ohio 44304-1407

United States

UT Southwestern Medical Center /ID# 269341

Dallas, Texas 75390

United States

Memorial Hermann Southeast Hospital /ID# 269347

Houston, Texas 77089

United States

Blacktown Hospital /ID# 269305

Blacktown, New South Wales 2148

Australia

Newcastle Private Hosptial /ID# 269306

Lambton Heights, New South Wales 2305

Australia

Monash Health - Monash Medical Centre - Clayton /ID# 269304

Clayton, Victoria 3168

Australia

Universitair Ziekenhuis Antwerpen /ID# 269310

Edegem, Antwerpen 2650

Belgium

OLV Ziekenhuis Aalst /ID# 269311

Aalst, Oost-Vlaanderen 9300

Belgium

AZ Sint-Lucas /ID# 269307

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Gent /ID# 269309

Ghent, Oost-Vlaanderen 9000

Belgium

Universitair Ziekenhuis Leuven /ID# 269308

Leuven, Vlaams-Brabant 3000

Belgium

CHU de Liege /ID# 269312

Liège, 4000

Belgium

Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862

Montreal, Quebec H1T 2M4

Canada

Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314

Montreal, Quebec H2L 4M1

Canada

McGill University Health Centre - Glen Site. /ID# 269313

Montreal, Quebec H4A 3J1

Canada

Institut Paoli-Calmettes /ID# 269648

Marseille, Bouches-du-Rhone 13273

France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301

Tours, Indre-et-Loire 37000

France

Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330

Paris, Paris 75679

France

Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327

Pierre-Bénite, Rhone 69310

France

Clinique Victor Hugo Le Mans /ID# 269985

Le Mans, Sarthe 72000

France

GH Diaconesses Croix Saint-Simon /ID# 269329

Paris, 75020

France

Mater Misericordiae University Hospital /ID# 269334

Dublin, D07 R2WY

Ireland

Beaumont Hospital /ID# 268864

Dublin, D09 XR63

Ireland

Hospital San Pedro de Alcántara /ID# 269320

Cáceres, Caceres 10003

Spain

Hospital Universitario de Jaén /ID# 269319

Jaén, Jaen 23007

Spain

Usp Instituto Universitario Dexeus /ID# 269322

Barcelona, 08028

Spain

Hospital Universitario Vall de Hebron /ID# 269315

Barcelona, 08035

Spain

Hospital Universitario Ramon y Cajal /ID# 269318

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre /ID# 269321

Madrid, 28041

Spain

Hospital Universitario La Paz /ID# 269302

Madrid, 28046

Spain

Hospital Universitario y Politecnico La Fe /ID# 269325

Valencia, 46026

Spain