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RecruitingInterventionalPhase 2

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

NCT ID: NCT06890338Sponsor: AbbVieLast updated: 2026-06-16

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.

Arms & interventions

  • DrugCarboplatin

    Intravenous (IV) infusion

  • DrugMirvetuximab Soravtansine

    Intravenous (IV) infusion

  • DrugBevacizumab

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

Outcome measures

Primary

  • Objective Response (OR) by Independent Central Review (ICR)

    OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).

    Time frame: Up to Approximately 3 years

Secondary

  • Percentage of Participants with Adverse Events (AE)

    Time frame: Up to Approximately 3 years

  • Percentage of Participants with AEs leading to study drug discontinuation or dose modification

    Time frame: Up to Approximately 3 years

  • Objective Response (OR) by Investigator

    Time frame: Up to Approximately 3 years

  • Disease Control by ICR

    Time frame: Up to Approximately 3 years

  • Disease control by Investigator

    Time frame: Up to Approximately 3 years

  • Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

    Time frame: Up to Approximately 3 years

  • Progression-Free Survival (PFS) by investigator

    Time frame: Up to Approximately 3 years

  • Percentage of Participants that Underwent Interval debulking surgery (IDS)

    Time frame: Up to Approximately 3 years

  • Percentage of participants with complete tumor cytoreduction at IDS

    Time frame: Up to Approximately 3 years

  • Percentage of participants with Incomplete Tumor Cytoreduction at IDS

    Time frame: Up to Approximately 3 years

  • Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P)

    Time frame: Up to Approximately 3 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (66)

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

Birmingham, Alabama, 35294

Recruiting

Usa Mitchell Cancer Institute /ID# 276022

Mobile, Alabama, 36604

Recruiting

University of California Los Angeles Medical Center /ID# 274566

Los Angeles, California, 90095

Recruiting

Scripps Md Anderson - Prebys Cancer Center /ID# 276891

San Diego, California, 92103

Recruiting

California Pacific Medical Center /ID# 275329

San Francisco, California, 94109

Recruiting

Ridley Tree Cancer Center /ID# 275219

Santa Barbara, California, 93105

Active Not Recruiting

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Danbury, Connecticut, 06810

Recruiting

Yale University School of Medicine /ID# 275794

New Haven, Connecticut, 06510

Recruiting

Norwalk Hospital /ID# 274561

Norwalk, Connecticut, 06856

Recruiting

Jupiter Medical Center /ID# 276616

Jupiter, Florida, 33458

Recruiting

Mount Sinai Medical Center /ID# 274868

Miami Beach, Florida, 33140

Recruiting
Site Coordinator · Contact
0

Rush Md Anderson Cancer Center /ID# 274926

Chicago, Illinois, 60607

Recruiting

OSF St. Francis Medical Center /ID# 274752

Peoria, Illinois, 61637-0001

Recruiting

Carle Foundation Hospital /ID# 276470

Urbana, Illinois, 61801

Recruiting

Parkview Research Center /ID# 274338

Fort Wayne, Indiana, 46845

Recruiting

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

Indianapolis, Indiana, 46202

Recruiting

Baptist Health Lexington /ID# 275218

Lexington, Kentucky, 40503

Recruiting

Norton Cancer Institute - St. Matthews /ID# 276173

Louisville, Kentucky, 40207

Recruiting

Women'S Cancer Care /ID# 276469

Covington, Louisiana, 70433

Recruiting

University Medical Center New Orleans /ID# 274755

New Orleans, Louisiana, 70112

Recruiting

Trials 365 /ID# 274310

Shreveport, Louisiana, 71103

Recruiting

University of Maryland, Baltimore /ID# 275308

Baltimore, Maryland, 21201

Recruiting

Holy Cross Hospital /ID# 275872

Silver Spring, Maryland, 20910

Recruiting

University of Minnesota - Minneapolis /ID# 275718

Minneapolis, Minnesota, 55455-0341

Recruiting

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

Saint Louis Park, Minnesota, 55416

Recruiting

University Of Mississippi Medical Center /ID# 276342

Jackson, Mississippi, 39216

Recruiting

Cox Medical Center South /ID# 274826

Springfield, Missouri, 65807

Recruiting

Mercy Hospital St. Louis /ID# 275655

St Louis, Missouri, 63141

Recruiting

The Center Of Hope /ID# 274313

Reno, Nevada, 89511

Recruiting

Dartmouth-Hitchcock Medical Center /ID# 274676

Lebanon, New Hampshire, 03756

Recruiting

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey, 08901

Recruiting

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey, 07666

Recruiting

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico, 87109

Recruiting

Imbert Cancer Center /ID# 275634

Bay Shore, New York, 11706

Recruiting

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York, 11740

Recruiting

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York, 11042

Recruiting

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York, 11374

Recruiting

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina, 27514

Recruiting

Atrium Health Levine Cancer Institute /ID# 274557

Charlotte, North Carolina, 28204

Recruiting

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

Greenville, North Carolina, 27834

Recruiting

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Winston-Salem, North Carolina, 27157

Recruiting

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota, 58102

Recruiting

Cleveland Clinic - Cleveland /ID# 276133

Cleveland, Ohio, 44195

Recruiting

Cleveland Clinic - Cleveland /ID# 278273

Cleveland, Ohio, 44195

Recruiting

Cleveland Clinic - Cleveland /ID# 278274

Cleveland, Ohio, 44195

Recruiting

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio, 43219

Recruiting

Kettering Medical Center /ID# 274365

Kettering, Ohio, 45429

Recruiting

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

Eugene, Oregon, 97401

Recruiting

Compass Oncology - West - Tigard /ID# 275101

Tigard, Oregon, 97223

Recruiting
Site Coordinator · Contact
(971) 708-7600

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania, 18015

Recruiting

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania, 19104

Recruiting

Women & Infants Hospital /ID# 274716

Providence, Rhode Island, 02905

Recruiting

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota, 57104

Recruiting

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota, 57105

Recruiting

Texas Oncology - Austin Central /ID# 275046

Austin, Texas, 78731

Recruiting

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas, 76104

Recruiting

Houston Methodist Hospital /ID# 274568

Houston, Texas, 77030

Recruiting
Site Coordinator · Contact
713.441.3250

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

San Antonio, Texas, 78240

Recruiting

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas, 77380

Recruiting

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas, 75702

Recruiting

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia, 22903

Recruiting

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

Fairfax, Virginia, 22031

Recruiting

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

Norfolk, Virginia, 23502-2800

Recruiting

Carilion Roanoke Memorial Hospital /ID# 274684

Roanoke, Virginia, 24014

Recruiting

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

Spokane, Washington, 99204

Recruiting

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia, 26506

Recruiting