RecruitingPhase 2NCT06365853

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

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

Sponsor

AbbVie

Enrollment

100 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Recurrent Ovarian Cancer Folate Receptor-Alpha Positive

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at ways to reduce eye-related side effects of a cancer drug called mirvetuximab soravtansine in women with recurrent ovarian, fallopian tube, or peritoneal cancer whose tumors have high levels of a protein called folate receptor-alpha. **You may be eligible if...** - You have been diagnosed with epithelial ovarian, fallopian tube, or peritoneal cancer that has returned - Your tumor tests positive for high folate receptor-alpha expression - You are being treated with or are a candidate for mirvetuximab soravtansine **You may NOT be eligible if...** - You have pre-existing severe eye disease - You have other serious medical conditions that would make participation unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirvetuximab 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.

DRUGLubricating Eye Drops

Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.

DRUGPrednisolone acetate ophthalmic suspension 1% eye drops

Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.

DRUGBrimonidine tartrate ophthalmic solution eye drops

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

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

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NCT06365853

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