RecruitingPhase 2NCT06890338

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.

A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer


Sponsor

AbbVie

Enrollment

140 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests mirvetuximab soravtansine (an antibody-drug conjugate — an antibody that delivers chemotherapy directly to cancer cells) combined with carboplatin (a standard chemotherapy) for women with newly diagnosed, advanced ovarian, fallopian tube, or peritoneal cancer whose tumors express a protein called folate receptor alpha (FRα). This combination is given before surgery (neoadjuvant). **You may be eligible if...** - You have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer at Stage III or IV, confirmed by biopsy - Your tumor tests positive for the folate receptor alpha (FRα) protein - Your doctor has recommended chemotherapy before surgery - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your tumor does not express FRα - You have already received chemotherapy for this cancer - You have significant eye problems, as the drug can affect vision 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCarboplatin

Intravenous (IV) infusion

DRUGMirvetuximab Soravtansine

Intravenous (IV) infusion

DRUGBevacizumab

Intravenous (IV) infusion (per investigator's discretion)


Locations(57)

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

Birmingham, Alabama, United States

Usa Mitchell Cancer Institute /ID# 276022

Mobile, Alabama, United States

Scripps Mercy Hospital /ID# 276891

San Diego, California, United States

California Pacific Medical Center /ID# 275329

San Francisco, California, United States

Ridley Tree Cancer Center /ID# 275219

Santa Barbara, California, United States

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Danbury, Connecticut, United States

Yale University School of Medicine /ID# 275794

New Haven, Connecticut, United States

Norwalk Hospital /ID# 274561

Norwalk, Connecticut, United States

Jupiter Medical Center /ID# 276616

Jupiter, Florida, United States

Mount Sinai Medical Center /ID# 274868

Miami, Florida, United States

Rush Md Anderson Cancer Center /ID# 274926

Chicago, Illinois, United States

OSF St. Francis Medical Center /ID# 274752

Peoria, Illinois, United States

Parkview Research Center /ID# 274338

Fort Wayne, Indiana, United States

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

Indianapolis, Indiana, United States

Baptist Health Lexington /ID# 275218

Lexington, Kentucky, United States

Norton Cancer Institute - St. Matthews /ID# 276173

Louisville, Kentucky, United States

Women'S Cancer Care /ID# 276469

Covington, Louisiana, United States

University Medical Center New Orleans /ID# 274755

New Orleans, Louisiana, United States

Trials 365 /ID# 274310

Shreveport, Louisiana, United States

University of Maryland, Baltimore /ID# 275308

Baltimore, Maryland, United States

Holy Cross Hospital /ID# 275872

Silver Spring, Maryland, United States

University of Minnesota - Minneapolis /ID# 275718

Minneapolis, Minnesota, United States

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

Saint Louis Park, Minnesota, United States

Cox Medical Center South /ID# 274826

Springfield, Missouri, United States

The Center Of Hope /ID# 274313

Reno, Nevada, United States

Dartmouth-Hitchcock Medical Center /ID# 274676

Lebanon, New Hampshire, United States

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey, United States

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey, United States

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico, United States

Imbert Cancer Center /ID# 275634

Bay Shore, New York, United States

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York, United States

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York, United States

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York, United States

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina, United States

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

Greenville, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Winston-Salem, North Carolina, United States

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota, United States

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio, United States

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

Eugene, Oregon, United States

Northwest Cancer Specialists /ID# 275101

Portland, Oregon, United States

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania, United States

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania, United States

Women & Infants Hospital /ID# 274716

Providence, Rhode Island, United States

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota, United States

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota, United States

Texas Oncology - Austin Central /ID# 275046

Austin, Texas, United States

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas, United States

Houston Methodist Hospital /ID# 274568

Houston, Texas, United States

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

San Antonio, Texas, United States

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas, United States

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas, United States

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia, United States

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

Fairfax, Virginia, United States

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

Norfolk, Virginia, United States

Carilion Roanoke Memorial Hospital /ID# 274684

Roanoke, Virginia, United States

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

Spokane, Washington, United States

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06890338


Related Trials