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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.

RecruitingPhase 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

Who can join

Ages 18 and older · Women

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.

About the study

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.

What is being tested

Sponsor: AbbVie · Participants: 140 · Started: Nov 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06890338

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham (UAB) Hospital /ID# 274793, Birmingham
Usa Mitchell Cancer Institute /ID# 276022, Mobile
CaliforniaUCLA - University of California Los Angeles Medical Center /ID# 274566, Los Angeles
Scripps Md Anderson - Prebys Cancer Center /ID# 276891, San Diego
California Pacific Medical Center - Van Ness Campus /ID# 275329, San Francisco
ConnecticutDanbury Hospital, Western Connecticut Health Network /ID# 274783, Danbury
Yale University School of Medicine /ID# 275794, New Haven
Norwalk Hospital /ID# 274561, Norwalk
FloridaJupiter Medical Center /ID# 276616, Jupiter
Mount Sinai Medical Center /ID# 274868, Miami Beach
IllinoisRush Md Anderson Cancer Center /ID# 274926, Chicago
University of Chicago Medical Center /ID# 274796, Chicago
OSF St. Francis Medical Center /ID# 274752, Peoria
Carle Foundation Hospital /ID# 276470, Urbana
IndianaParkview Research Center /ID# 274338, Fort Wayne
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492, Indianapolis
KentuckyBaptist Health Lexington /ID# 275218, Lexington
Norton Cancer Institute - St. Matthews /ID# 276173, Louisville
LouisianaWomen'S Cancer Care /ID# 276469, Covington
University Medical Center New Orleans /ID# 274755, New Orleans
Trials 365 /ID# 274310, Shreveport
MarylandUniversity of Maryland, Baltimore /ID# 275308, Baltimore
Holy Cross Hospital /ID# 275872, Silver Spring
MinnesotaUniversity of Minnesota - Minneapolis /ID# 275718, Minneapolis
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780, Saint Louis Park
MississippiUniversity Of Mississippi Medical Center /ID# 276342, Jackson
MissouriCox Medical Center South /ID# 274826, Springfield
Mercy David C. Pratt Cancer Center /ID# 275655, St Louis
NevadaThe Center Of Hope /ID# 274313, Reno
New HampshireDartmouth-Hitchcock Medical Center /ID# 274676, Lebanon
New JerseyJohn Theurer Cancer Center /ID# 275756, Hackensack
Rutgers Cancer Institute of New Jersey /ID# 274358, New Brunswick
Holy Name Medical Center /ID# 276240, Teaneck
New MexicoOptimum Clinical Research Group /ID# 274583, Albuquerque
New YorkImbert Cancer Center /ID# 275634, Bay Shore
Northwell Health Cancer Institute At Huntington /ID# 276814, Greenlawn
Northwell Health Center for Advanced Medicine. /ID# 275641, Lake Success
Northwell Health Queens Cancer Center /ID# 274850, Rego Park
Good Samaritan Hospital Medical Center /ID# 274938, West Islip
North CarolinaUniversity of North Carolina Medical Center /ID# 275307, Chapel Hill
Atrium Health Levine Cancer Institute /ID# 274557, Charlotte
East Carolina University - Brody School of Medicine /ID# 275770, Greenville
Atrium Health Wake Forest Baptist Medical Center /ID# 276952, Winston-Salem
North DakotaSanford Fargo Medical Center - Fargo /ID# 275489, Fargo
OhioCleveland Clinic - Cleveland /ID# 276133, Cleveland
Cleveland Clinic - Cleveland /ID# 278273, Cleveland
Cleveland Clinic - Cleveland /ID# 278274, Cleveland
Metrohealth Medical Center - Cleveland /ID# 276664, Cleveland
The Mark H Zangmeister Center /ID# 275106, Columbus
Kettering Medical Center /ID# 274365, Kettering
OregonOncology Associates of Oregon, P.C. /ID# 275006, Eugene
Compass Oncology - West - Tigard /ID# 275101, Tigard
PennsylvaniaSt. Lukes University Hospital /ID# 274362, Bethlehem
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612, Philadelphia
Rhode IslandWomen & Infants Hospital /ID# 274716, Providence
South DakotaAvera Cancer Institute - Sioux Falls /ID# 276226, Sioux Falls
Sanford Cancer Center /ID# 274901, Sioux Falls
TexasTexas Oncology - Austin Central /ID# 275046, Austin
Texas Oncology - Fort Worth Cancer Center /ID# 275043, Fort Worth
Houston Methodist Hospital /ID# 274568, Houston
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090, San Antonio
Texas Oncology - The Woodlands /ID# 275015, The Woodlands
Texas Oncology - Northeast Texas /ID# 275057, Tyler
VirginiaUVA Health University Hospital /ID# 275309, Charlottesville
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456, Fairfax
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227, Norfolk
Carilion Roanoke Memorial Hospital /ID# 274684, Roanoke
WashingtonProvidence Sacred Heart Medical Center & Children'S Hospital /ID# 274585, Spokane
West VirginiaWest Virginia University School of Medicine /ID# 274556, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.