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NCT06890338RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
140 (estimated)
First submitted
20 Mar 2025
Start date
21 Nov 2025
Primary completion date
Feb 2030
Lead sponsor
AbbVie
NCT number
NCT06890338

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 140
  • From 21 Nov 2025 to the primary completion date, Feb 2030
  • 73 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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.

Other

  • Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Optimum Clinical Research Group /ID# 274583
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
Texas Oncology - Austin Central /ID# 275046
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
University of Maryland, Baltimore /ID# 275308
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BaltimoreUnited StatesRecruiting
Imbert Cancer Center /ID# 275634
Coordinator of this site? Confirm its status
Bay ShoreUnited StatesRecruiting
St. Lukes University Hospital /ID# 274362
Coordinator of this site? Confirm its status
BethlehemUnited StatesRecruiting
University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
University of North Carolina Medical Center /ID# 275307
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Atrium Health Levine Cancer Institute /ID# 274557
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
UVA Health University Hospital /ID# 275309
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
University of Chicago Medical Center /ID# 274796
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ChicagoUnited StatesRecruiting
Rush Md Anderson Cancer Center /ID# 274926
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ChicagoUnited StatesRecruiting
Cleveland Clinic - Cleveland /ID# 276133
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Metrohealth Medical Center - Cleveland /ID# 276664
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ClevelandUnited StatesRecruiting
Cleveland Clinic - Cleveland /ID# 278274
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ClevelandUnited StatesRecruiting
Cleveland Clinic - Cleveland /ID# 278273
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
The Mark H Zangmeister Center /ID# 275106
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Women'S Cancer Care /ID# 276469
Coordinator of this site? Confirm its status
CovingtonUnited StatesRecruiting
Danbury Hospital, Western Connecticut Health Network /ID# 274783
Coordinator of this site? Confirm its status
DanburyUnited StatesRecruiting
Oncology Associates of Oregon, P.C. /ID# 275006
Coordinator of this site? Confirm its status
EugeneUnited StatesRecruiting
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Sanford Fargo Medical Center - Fargo /ID# 275489
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FargoUnited StatesRecruiting
Parkview Research Center /ID# 274338
Coordinator of this site? Confirm its status
Fort WayneUnited StatesRecruiting
Texas Oncology - Fort Worth Cancer Center /ID# 275043
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Northwell Health Cancer Institute At Huntington /ID# 276814
Coordinator of this site? Confirm its status
GreenlawnUnited StatesRecruiting
East Carolina University - Brody School of Medicine /ID# 275770
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
John Theurer Cancer Center /ID# 275756
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
Houston Methodist Hospital /ID# 274568
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Kaiser Permanente - Irvine /ID# 276924
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IrvineUnited StatesRecruiting
University Of Mississippi Medical Center /ID# 276342
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JacksonUnited StatesRecruiting
Jupiter Medical Center /ID# 276616
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JupiterUnited StatesRecruiting
Kettering Medical Center /ID# 274365
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KetteringUnited StatesRecruiting
Northwell Health Center for Advanced Medicine. /ID# 275641
Coordinator of this site? Confirm its status
Lake SuccessUnited StatesRecruiting
Dartmouth-Hitchcock Medical Center /ID# 274676
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
Baptist Health Lexington /ID# 275218
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LexingtonUnited StatesRecruiting
UCLA - University of California Los Angeles Medical Center /ID# 274566
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Norton Cancer Institute - St. Matthews /ID# 276173
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Mount Sinai Medical Center /ID# 274868
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Miami BeachUnited StatesCompleted
University of Minnesota - Minneapolis /ID# 275718
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MinneapolisUnited StatesRecruiting
Usa Mitchell Cancer Institute /ID# 276022
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MobileUnited StatesRecruiting
West Virginia University School of Medicine /ID# 274556
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MorgantownUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey /ID# 274358
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New BrunswickUnited StatesRecruiting
Yale University School of Medicine /ID# 275794
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New HavenUnited StatesRecruiting
University Medical Center New Orleans /ID# 274755
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New OrleansUnited StatesRecruiting
Columbia University Irving Medical Center /ID# 276156
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New YorkUnited StatesRecruiting
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227
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NorfolkUnited StatesRecruiting
Norwalk Hospital /ID# 274561
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NorwalkUnited StatesRecruiting
OSF St. Francis Medical Center /ID# 274752
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PeoriaUnited StatesRecruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612
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PhiladelphiaUnited StatesRecruiting
West Penn Hospital /ID# 276028
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PittsburghUnited StatesRecruiting
Women & Infants Hospital /ID# 274716
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ProvidenceUnited StatesRecruiting
Northwell Health Queens Cancer Center /ID# 274850
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Rego ParkUnited StatesRecruiting
The Center Of Hope /ID# 274313
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RenoUnited StatesRecruiting
Carilion Roanoke Memorial Hospital /ID# 274684
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RoanokeUnited StatesRecruiting
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
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Saint Louis ParkUnited StatesRecruiting
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Scripps Md Anderson - Prebys Cancer Center /ID# 276891
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
California Pacific Medical Center - Van Ness Campus /ID# 275329
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Ridley Tree Cancer Center /ID# 275219
Coordinator of this site? Confirm its status
Santa BarbaraUnited StatesActive, not recruiting
Willis-Knighton Medical Center /ID# 274310
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ShreveportUnited StatesRecruiting
Holy Cross Hospital /ID# 275872
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Silver SpringUnited StatesRecruiting
Avera Cancer Institute - Sioux Falls /ID# 276226
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Sioux FallsUnited StatesRecruiting
Sanford Cancer Center /ID# 274901
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Sioux FallsUnited StatesRecruiting
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
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SpokaneUnited StatesRecruiting
Cox Medical Center South /ID# 274826
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SpringfieldUnited StatesRecruiting
Mercy David C. Pratt Cancer Center /ID# 275655
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St LouisUnited StatesRecruiting
Holy Name Medical Center /ID# 276240
Coordinator of this site? Confirm its status
TeaneckUnited StatesRecruiting
Texas Oncology - The Woodlands /ID# 275015
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The WoodlandsUnited StatesRecruiting
Compass Oncology - West - Tigard /ID# 275101
Coordinator of this site? Confirm its status
TigardUnited StatesRecruiting
Texas Oncology - Northeast Texas /ID# 275057
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TylerUnited StatesRecruiting
Carle Foundation Hospital /ID# 276470
Coordinator of this site? Confirm its status
UrbanaUnited StatesRecruiting
Good Samaritan Hospital Medical Center /ID# 274938
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West IslipUnited StatesRecruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 276952
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.