NCT06890338From ClinicalTrials.govRecruiting

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

Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Neoadjuvant

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AbbVie
Enrolment target: 140
Started: 21 November 2025
Main results due: February 2030
Study sites: 70
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(70)

University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham, Alabama, United States
Recruiting
Usa Mitchell Cancer Institute /ID# 276022
Mobile, Alabama, United States
Recruiting
UCLA - University of California Los Angeles Medical Center /ID# 274566
Los Angeles, California, United States
Recruiting
Scripps Md Anderson - Prebys Cancer Center /ID# 276891
San Diego, California, United States
Recruiting
California Pacific Medical Center - Van Ness Campus /ID# 275329
San Francisco, California, United States
Recruiting
Ridley Tree Cancer Center /ID# 275219
Santa Barbara, California, United States
Active, not recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 274783
Danbury, Connecticut, United States
Recruiting
Yale University School of Medicine /ID# 275794
New Haven, Connecticut, United States
Recruiting
Norwalk Hospital /ID# 274561
Norwalk, Connecticut, United States
Recruiting
Jupiter Medical Center /ID# 276616
Jupiter, Florida, United States
Recruiting
Mount Sinai Medical Center /ID# 274868
Miami Beach, Florida, United States
Recruiting
Rush Md Anderson Cancer Center /ID# 274926
Chicago, Illinois, United States
Recruiting
University of Chicago Medical Center /ID# 274796
Chicago, Illinois, United States
Recruiting
OSF St. Francis Medical Center /ID# 274752
Peoria, Illinois, United States
Recruiting
Carle Foundation Hospital /ID# 276470
Urbana, Illinois, United States
Recruiting
Parkview Research Center /ID# 274338
Fort Wayne, Indiana, United States
Recruiting
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
Indianapolis, Indiana, United States
Recruiting
Baptist Health Lexington /ID# 275218
Lexington, Kentucky, United States
Recruiting
Norton Cancer Institute - St. Matthews /ID# 276173
Louisville, Kentucky, United States
Recruiting
Women'S Cancer Care /ID# 276469
Covington, Louisiana, United States
Recruiting
University Medical Center New Orleans /ID# 274755
New Orleans, Louisiana, United States
Recruiting
Trials 365 /ID# 274310
Shreveport, Louisiana, United States
Recruiting
University of Maryland, Baltimore /ID# 275308
Baltimore, Maryland, United States
Recruiting
Holy Cross Hospital /ID# 275872
Silver Spring, Maryland, United States
Recruiting
University of Minnesota - Minneapolis /ID# 275718
Minneapolis, Minnesota, United States
Recruiting
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
Saint Louis Park, Minnesota, United States
Recruiting
University Of Mississippi Medical Center /ID# 276342
Jackson, Mississippi, United States
Recruiting
Cox Medical Center South /ID# 274826
Springfield, Missouri, United States
Recruiting
Mercy David C. Pratt Cancer Center /ID# 275655
St Louis, Missouri, United States
Recruiting
The Center Of Hope /ID# 274313
Reno, Nevada, United States
Recruiting
Dartmouth-Hitchcock Medical Center /ID# 274676
Lebanon, New Hampshire, United States
Recruiting
John Theurer Cancer Center /ID# 275756
Hackensack, New Jersey, United States
Recruiting
Rutgers Cancer Institute of New Jersey /ID# 274358
New Brunswick, New Jersey, United States
Recruiting
Holy Name Medical Center /ID# 276240
Teaneck, New Jersey, United States
Recruiting
Optimum Clinical Research Group /ID# 274583
Albuquerque, New Mexico, United States
Recruiting
Imbert Cancer Center /ID# 275634
Bay Shore, New York, United States
Recruiting
Northwell Health Cancer Institute At Huntington /ID# 276814
Greenlawn, New York, United States
Recruiting
Northwell Health Center for Advanced Medicine. /ID# 275641
Lake Success, New York, United States
Recruiting
Northwell Health Queens Cancer Center /ID# 274850
Rego Park, New York, United States
Recruiting
Good Samaritan Hospital Medical Center /ID# 274938
West Islip, New York, United States
Recruiting
University of North Carolina Medical Center /ID# 275307
Chapel Hill, North Carolina, United States
Recruiting
Atrium Health Levine Cancer Institute /ID# 274557
Charlotte, North Carolina, United States
Recruiting
East Carolina University - Brody School of Medicine /ID# 275770
Greenville, North Carolina, United States
Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 276952
Winston-Salem, North Carolina, United States
Recruiting
Sanford Fargo Medical Center - Fargo /ID# 275489
Fargo, North Dakota, United States
Recruiting
Metrohealth Medical Center - Cleveland /ID# 276664
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic - Cleveland /ID# 276133
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic - Cleveland /ID# 278273
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic - Cleveland /ID# 278274
Cleveland, Ohio, United States
Recruiting
The Mark H Zangmeister Center /ID# 275106
Columbus, Ohio, United States
Recruiting
Kettering Medical Center /ID# 274365
Kettering, Ohio, United States
Recruiting
Oncology Associates of Oregon, P.C. /ID# 275006
Eugene, Oregon, United States
Recruiting
Compass Oncology - West - Tigard /ID# 275101
Tigard, Oregon, United States
Recruiting
St. Lukes University Hospital /ID# 274362
Bethlehem, Pennsylvania, United States
Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612
Philadelphia, Pennsylvania, United States
Recruiting
Women & Infants Hospital /ID# 274716
Providence, Rhode Island, United States
Recruiting
Sanford Cancer Center /ID# 274901
Sioux Falls, South Dakota, United States
Recruiting
Avera Cancer Institute - Sioux Falls /ID# 276226
Sioux Falls, South Dakota, United States
Recruiting
Texas Oncology - Austin Central /ID# 275046
Austin, Texas, United States
Recruiting
Texas Oncology - Fort Worth Cancer Center /ID# 275043
Fort Worth, Texas, United States
Recruiting

Showing 60 of 70 sites — filter to narrow it down. 69 of the 70 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06890338. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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