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

Last updated: March 24, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Recurrent Ovarian Cancer

Treatment

Mirvetuximab Soravtansine

Brimonidine tartrate ophthalmic solution eye drops

Prednisolone acetate ophthalmic suspension 1% eye drops

Clinical Study ID

NCT06365853
IMGN853-0424
2023-505617-24-00
  • Ages > 18
  • Female

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 Criteria

Inclusion

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 Ventanafolate receptor 1 (FOLR1) (FOLR1-2.1) CDx Assay or FOLR1-2.1 RxDx Assay (hereaftercollectively termed: Ventana FOLR1 Assay) (≥75% cells exhibit 2 or 3+membrane-staining intensity).

  • Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor orgermline) 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 isshorter) 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 priortherapy-related toxicities (except alopecia).

  • Women of childbearing potential (WOCBP) must agree to use highly effectivecontraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; andmust have a negative pregnancy test ≤ 4 days before the first dose of MIRV.

Exclusion

Exclusion Criteria:

  • Participants with borderline ovarian tumor or non-epithelial histology or mixedhistology including borderline or non-epithelial histology will be excluded.

  • PROC participants with primary platinum-refractory disease, defined as disease thatdid not respond to (complete response [CR] or partial response [PR]) or progressedwithin ≤ 3 months of the last dose of first line platinum-containing chemotherapy.

  • Participants with > Grade 1 peripheral neuropathy per National CancerInstitute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAEv5.0).

  • Participants with significant active or chronic corneal disorders (for example,corneal dystrophies, degenerations, limbal stem cell deficiency), history of cornealtransplantation, significant ocular inflammatory conditions (for example, active orrecurrent uveitis), or other active ocular conditions requiring ongoingtreatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathywith macular edema, macular degeneration requiring treatment ≤ 90 days before firstdose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70in either eye, or monocular vision.

  • Participants receiving corticosteroid or vasoconstricting eyedrops at baseline orwithin 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

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Mirvetuximab Soravtansine
Phase: 2
Study Start date:
July 29, 2024
Estimated Completion Date:
June 30, 2027

Study 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).

Connect with a study center

  • Blacktown Hospital /ID# 269305

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Newcastle Private Hosptial /ID# 269306

    Lambton Heights, New South Wales 2305
    Australia

    Active - Recruiting

  • Monash University - Monash Medical Centre (MMC) - Clayton

    Clayton, Victoria
    Australia

    Site Not Available

  • Monash University Clayton Campus /ID# 269304

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek

    Edegem, Antwerp
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen /ID# 269310

    Edegem, Antwerpen 2650
    Belgium

    Active - Recruiting

  • AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek

    Gent, East Flanders
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent (UZ Gent)

    Gent, East Flanders
    Belgium

    Site Not Available

  • Onze Lieve Vrouw Ziekenhuis Aalst /ID# 269311

    Aalst, Oost-Vlaanderen 9300
    Belgium

    Active - Recruiting

  • AZ Sint-Lucas /ID# 269307

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Gent /ID# 269309

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Leuven /ID# 269308

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre

    Montreal, Quebec
    Canada

    Site Not Available

  • Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame

    Montreal, Quebec
    Canada

    Site Not Available

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

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Institut Paoli-Calmettes /ID# 269648

    Marseille, Bouches-du-Rhone 13273
    France

    Active - Recruiting

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

    Tours, Indre-et-Loire 37000
    France

    Active - Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330

    Paris CEDEX 14, Paris 75679
    France

    Active - Recruiting

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

    Pierre Benite, Rhone 69310
    France

    Active - Recruiting

  • Clinique Victor Hugo Le Mans /ID# 269985

    Le Mans, Sarthe 72000
    France

    Active - Recruiting

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin

    Paris,
    France

    Site Not Available

  • GH Diaconesses Croix Saint-Simon /ID# 269329

    Paris, 75020
    France

    Active - Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon

    Paris,
    France

    Site Not Available

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre Benite,
    France

    Site Not Available

  • Beaumont Hospital /ID# 268864

    Dublin, D09 XR63
    Ireland

    Active - Recruiting

  • Bon Secours Hospital - Dublin

    Dublin,
    Ireland

    Site Not Available

  • Mater Misericordiae University Hospital (MMUH) (START Dublin)

    Dublin,
    Ireland

    Site Not Available

  • Mater Misericordiae University Hospital /ID# 269334

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)

    Milan,
    Italy

    Site Not Available

  • Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location

    Badalona, Barcelona
    Spain

    Site Not Available

  • Hospital San Pedro de Alcántara /ID# 269320

    Cáceres, Caceres 10003
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaén /ID# 269319

    Jaén, Jaen 23007
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron /ID# 269315

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Parc Taulí

    Barcelona,
    Spain

    Site Not Available

  • Usp Instituto Universitario Dexeus /ID# 269322

    Barcelona, 08028
    Spain

    Active - Recruiting

  • Vall d'Hebron Institut d'Oncologia

    Barcelona,
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)

    Jaen,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre /ID# 269321

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz /ID# 269302

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 269318

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 269325

    Valencia, 46026
    Spain

    Active - Recruiting

  • University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale School of Medicine - Yale Gynecologic Oncology

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Norton Healthcare /ID# 269070

    Louisville, Kentucky 40207-4700
    United States

    Active - Recruiting

  • Holy Cross Hospital

    Silver Spring, Maryland 20910
    United States

    Site Not Available

  • Holy Cross Hospital - Silver Spring /ID# 269344

    Silver Spring, Maryland 20910
    United States

    Active - Recruiting

  • Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • The Center Of Hope /ID# 269348

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • Holy Name Medical Center /ID# 269340

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • New York Oncology Hematology

    Albany, New York 12208
    United States

    Active - Recruiting

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

    Albany, New York 12206-5013
    United States

    Active - Recruiting

  • Women'S Cancer Care Associates /ID# 269980

    Albany, New York 12208
    United States

    Active - Recruiting

  • Women's Cancer Care Associates, LLC

    Albany, New York 12208
    United States

    Active - Recruiting

  • New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion

    New York, New York 10032
    United States

    Site Not Available

  • Duke Cancer Institute (DCI) - Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic

    Dallas, Texas 75235
    United States

    Site Not Available

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