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NCT06890338PHASE2Recruiting

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

AbbVie

Start Date

11/21/2025

Completion Date

2/1/2030

Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy. * Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer. * Participant meets the following disease criteria: * Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate \>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Exclusion Criteria: * Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor. * Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis. * Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin * Participants with the following ocular history and/or concurrent disorders: * History of corneal transplantation; * Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery; * Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention; * Active or chronic clinically significant (\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy); * Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment; * Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye). * History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

Interventions

DRUG

Carboplatin

DRUG

Mirvetuximab Soravtansine

DRUG

Bevacizumab

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Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerNeoadjuvant

Locations

University of Alabama at Birmingham (UAB) Hospital /ID# 274793

Birmingham, Alabama 35294

United States

Usa Mitchell Cancer Institute /ID# 276022

Mobile, Alabama 36604

United States

University of California Los Angeles Medical Center /ID# 274566

Los Angeles, California 90095

United States

Scripps Md Anderson - Prebys Cancer Center /ID# 276891

San Diego, California 92103

United States

California Pacific Medical Center - Van Ness Campus /ID# 275329

San Francisco, California 94109

United States

Ridley Tree Cancer Center /ID# 275219

Santa Barbara, California 93105

United States

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Danbury, Connecticut 06810

United States

Yale University School of Medicine /ID# 275794

New Haven, Connecticut 06510

United States

Norwalk Hospital /ID# 274561

Norwalk, Connecticut 06856

United States

Jupiter Medical Center /ID# 276616

Jupiter, Florida 33458

United States

Mount Sinai Medical Center /ID# 274868

Miami Beach, Florida 33140

United States

Rush Md Anderson Cancer Center /ID# 274926

Chicago, Illinois 60607

United States

OSF St. Francis Medical Center /ID# 274752

Peoria, Illinois 61637-0001

United States

Carle Foundation Hospital /ID# 276470

Urbana, Illinois 61801

United States

Parkview Research Center /ID# 274338

Fort Wayne, Indiana 46845

United States

Indiana University Melvin and Bren Simon Cancer Center /ID# 275492

Indianapolis, Indiana 46202

United States

Baptist Health Lexington /ID# 275218

Lexington, Kentucky 40503

United States

Norton Cancer Institute - St. Matthews /ID# 276173

Louisville, Kentucky 40207

United States

Women'S Cancer Care /ID# 276469

Covington, Louisiana 70433

United States

University Medical Center New Orleans /ID# 274755

New Orleans, Louisiana 70112

United States

Trials 365 /ID# 274310

Shreveport, Louisiana 71103

United States

University of Maryland, Baltimore /ID# 275308

Baltimore, Maryland 21201

United States

Holy Cross Hospital /ID# 275872

Silver Spring, Maryland 20910

United States

University of Minnesota - Minneapolis /ID# 275718

Minneapolis, Minnesota 55455-0341

United States

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780

Saint Louis Park, Minnesota 55416

United States

University Of Mississippi Medical Center /ID# 276342

Jackson, Mississippi 39216

United States

Cox Medical Center South /ID# 274826

Springfield, Missouri 65807

United States

Mercy David C. Pratt Cancer Center /ID# 275655

St Louis, Missouri 63141

United States

The Center Of Hope /ID# 274313

Reno, Nevada 89511

United States

Dartmouth-Hitchcock Medical Center /ID# 274676

Lebanon, New Hampshire 03756

United States

John Theurer Cancer Center /ID# 275756

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey 08901

United States

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey 07666

United States

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico 87109

United States

Imbert Cancer Center /ID# 275634

Bay Shore, New York 11706

United States

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York 11740

United States

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York 11042

United States

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York 11374

United States

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina 27514

United States

Atrium Health Levine Cancer Institute /ID# 274557

Charlotte, North Carolina 28204

United States

East Carolina University - Brody School of Medicine /ID# 275770

Greenville, North Carolina 27834

United States

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Winston-Salem, North Carolina 27157

United States

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota 58102

United States

Cleveland Clinic - Cleveland /ID# 276133

Cleveland, Ohio 44195

United States

Cleveland Clinic - Cleveland /ID# 278273

Cleveland, Ohio 44195

United States

Cleveland Clinic - Cleveland /ID# 278274

Cleveland, Ohio 44195

United States

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio 43219

United States

Kettering Medical Center /ID# 274365

Kettering, Ohio 45429

United States

Oncology Associates of Oregon, P.C. /ID# 275006

Eugene, Oregon 97401

United States

Compass Oncology - West - Tigard /ID# 275101

Tigard, Oregon 97223

United States

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania 18015

United States

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania 19104

United States

Women & Infants Hospital /ID# 274716

Providence, Rhode Island 02905

United States

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota 57104

United States

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota 57105

United States

Texas Oncology - Austin Central /ID# 275046

Austin, Texas 78731

United States

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas 76104

United States

Houston Methodist Hospital /ID# 274568

Houston, Texas 77030

United States

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090

San Antonio, Texas 78240

United States

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas 77380

United States

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas 75702

United States

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia 22903

United States

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456

Fairfax, Virginia 22031

United States

Virginia Oncology Associates- Norfolk (Brock) /ID# 275227

Norfolk, Virginia 23502-2800

United States

Carilion Roanoke Memorial Hospital /ID# 274684

Roanoke, Virginia 24014

United States

Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585

Spokane, Washington 99204

United States

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia 26506

United States