Recruiting

Phase 2

MIRV & CarboplatinA 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.

Sponsor:

AbbVie

Code:

NCT06890338

Conditions

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Neoadjuvant

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Mirvetuximab Soravtansine

Bevacizumab

Study Details

Brief 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.

Conditions

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Neoadjuvant

Study ID

NCT06890338

Start date

Nov 21, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carboplatin + Mirvetuximab Soravtansine

Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.

Interventions

Carboplatin

Intravenous (IV) infusion

Mirvetuximab Soravtansine

Intravenous (IV) infusion

Bevacizumab

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

Primary outcome measure

Objective Response (OR) by Independent Central Review (ICR) [ Time Frame: Up to Approximately 3 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Birmingham, Alabama, United States, 35294

Usa Mitchell Cancer Institute /ID# 276022

Recruiting

Mobile, Alabama, United States, 36604

University of California Los Angeles Medical Center /ID# 274566

Recruiting

Los Angeles, California, United States, 90095

Scripps Md Anderson - Prebys Cancer Center /ID# 276891

Recruiting

San Diego, California, United States, 92103

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

Recruiting

San Francisco, California, United States, 94109

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Recruiting

Danbury, Connecticut, United States, 06810

Yale University School of Medicine /ID# 275794

Recruiting

New Haven, Connecticut, United States, 06510

Norwalk Hospital /ID# 274561

Recruiting

Norwalk, Connecticut, United States, 06856

Jupiter Medical Center /ID# 276616

Recruiting

Jupiter, Florida, United States, 33458

Mount Sinai Medical Center /ID# 274868

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Site Coordinator

Rush Md Anderson Cancer Center /ID# 274926

Recruiting

Chicago, Illinois, United States, 60607

University of Chicago Medical Center /ID# 274796

Recruiting

Chicago, Illinois, United States, 60637

OSF St. Francis Medical Center /ID# 274752

Recruiting

Peoria, Illinois, United States, 61637-0001

Carle Foundation Hospital /ID# 276470

Recruiting

Urbana, Illinois, United States, 61801

Parkview Research Center /ID# 274338

Recruiting

Fort Wayne, Indiana, United States, 46845

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

Recruiting

Indianapolis, Indiana, United States, 46202

Baptist Health Lexington /ID# 275218

Recruiting

Lexington, Kentucky, United States, 40503

Norton Cancer Institute - St. Matthews /ID# 276173

Recruiting

Louisville, Kentucky, United States, 40207

Women'S Cancer Care /ID# 276469

Recruiting

Covington, Louisiana, United States, 70433

University Medical Center New Orleans /ID# 274755

Recruiting

New Orleans, Louisiana, United States, 70112

Trials 365 /ID# 274310

Recruiting

Shreveport, Louisiana, United States, 71103

University of Maryland, Baltimore /ID# 275308

Recruiting

Baltimore, Maryland, United States, 21201

Holy Cross Hospital /ID# 275872

Recruiting

Silver Spring, Maryland, United States, 20910

University of Minnesota - Minneapolis /ID# 275718

Recruiting

Minneapolis, Minnesota, United States, 55455-0341

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

Recruiting

Saint Louis Park, Minnesota, United States, 55416

University Of Mississippi Medical Center /ID# 276342

Recruiting

Jackson, Mississippi, United States, 39216

Cox Medical Center South /ID# 274826

Recruiting

Springfield, Missouri, United States, 65807

Mercy David C. Pratt Cancer Center /ID# 275655

Recruiting

St Louis, Missouri, United States, 63141

The Center Of Hope /ID# 274313

Recruiting

Reno, Nevada, United States, 89511

Dartmouth-Hitchcock Medical Center /ID# 274676

Recruiting

Lebanon, New Hampshire, United States, 03756

John Theurer Cancer Center /ID# 275756

Recruiting

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey /ID# 274358

Recruiting

New Brunswick, New Jersey, United States, 08901

Holy Name Medical Center /ID# 276240

Recruiting

Teaneck, New Jersey, United States, 07666

Optimum Clinical Research Group /ID# 274583

Recruiting

Albuquerque, New Mexico, United States, 87109

Imbert Cancer Center /ID# 275634

Recruiting

Bay Shore, New York, United States, 11706

Northwell Health Cancer Institute At Huntington /ID# 276814

Recruiting

Greenlawn, New York, United States, 11740

Northwell Health Center for Advanced Medicine. /ID# 275641

Recruiting

Lake Success, New York, United States, 11042

Northwell Health Queens Cancer Center /ID# 274850

Recruiting

Rego Park, New York, United States, 11374

University of North Carolina Medical Center /ID# 275307

Recruiting

Chapel Hill, North Carolina, United States, 27514

Atrium Health Levine Cancer Institute /ID# 274557

Recruiting

Charlotte, North Carolina, United States, 28204

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

Recruiting

Greenville, North Carolina, United States, 27834

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Recruiting

Winston-Salem, North Carolina, United States, 27157

Sanford Fargo Medical Center - Fargo /ID# 275489

Recruiting

Fargo, North Dakota, United States, 58102

Metrohealth Medical Center - Cleveland /ID# 276664

Recruiting

Cleveland, Ohio, United States, 44109

Cleveland Clinic - Cleveland /ID# 276133

Recruiting

Cleveland, Ohio, United States, 44195

Cleveland Clinic - Cleveland /ID# 278273

Recruiting

Cleveland, Ohio, United States, 44195

Cleveland Clinic - Cleveland /ID# 278274

Recruiting

Cleveland, Ohio, United States, 44195

The Mark H Zangmeister Center /ID# 275106

Recruiting

Columbus, Ohio, United States, 43219

Kettering Medical Center /ID# 274365

Recruiting

Kettering, Ohio, United States, 45429

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

Recruiting

Eugene, Oregon, United States, 97401

Compass Oncology - West - Tigard /ID# 275101

Recruiting

Tigard, Oregon, United States, 97223

Contacts

Site Coordinator

(971) 708-7600

St. Lukes University Hospital /ID# 274362

Recruiting

Bethlehem, Pennsylvania, United States, 18015

University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Women & Infants Hospital /ID# 274716

Recruiting

Providence, Rhode Island, United States, 02905

Sanford Cancer Center /ID# 274901

Recruiting

Sioux Falls, South Dakota, United States, 57104

Avera Cancer Institute - Sioux Falls /ID# 276226

Recruiting

Sioux Falls, South Dakota, United States, 57105

Texas Oncology - Austin Central /ID# 275046

Recruiting

Austin, Texas, United States, 78731

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Recruiting

Fort Worth, Texas, United States, 76104

Houston Methodist Hospital /ID# 274568

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Coordinator

713.441.3250

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

Recruiting

San Antonio, Texas, United States, 78240

Texas Oncology - The Woodlands /ID# 275015

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Northeast Texas /ID# 275057

Recruiting

Tyler, Texas, United States, 75702

UVA Health University Hospital /ID# 275309

Recruiting

Charlottesville, Virginia, United States, 22903

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

Recruiting

Fairfax, Virginia, United States, 22031

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

Recruiting

Norfolk, Virginia, United States, 23502-2800

Carilion Roanoke Memorial Hospital /ID# 274684

Recruiting

Roanoke, Virginia, United States, 24014

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

Recruiting

Spokane, Washington, United States, 99204

West Virginia University School of Medicine /ID# 274556

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

AbbVie

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Neoadjuvant
Interval Debulking Surgery
Mirvetuximab Soravtansine
MIRV
IMGN853
ELAHERE(R)
Carboplatin
Bevacizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-01.