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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.
NCT06890338 · AbbVie
In plain English
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Official title
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
About this 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.
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.
Study design
Enrollment target: 140 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-21
Estimated completion: 2030-02
Last updated: 2026-04-14
Interventions
Drug: CarboplatinDrug: Mirvetuximab SoravtansineDrug: Bevacizumab
Primary outcomes
- • Objective Response (OR) by Independent Central Review (ICR) (Up to Approximately 3 years)
Sponsor
AbbVie · industry
With: GOG Foundation
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (57)
University of Alabama at Birmingham (UAB) Hospital /ID# 274793Recruiting
Birmingham, Alabama, United States
Usa Mitchell Cancer Institute /ID# 276022Recruiting
Mobile, Alabama, United States
Scripps Mercy Hospital /ID# 276891Recruiting
San Diego, California, United States
California Pacific Medical Center /ID# 275329Recruiting
San Francisco, California, United States
Ridley Tree Cancer Center /ID# 275219Recruiting
Santa Barbara, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 274783Recruiting
Danbury, Connecticut, United States
Yale University School of Medicine /ID# 275794Recruiting
New Haven, Connecticut, United States
Norwalk Hospital /ID# 274561Recruiting
Norwalk, Connecticut, United States
Jupiter Medical Center /ID# 276616Recruiting
Jupiter, Florida, United States
Mount Sinai Medical Center /ID# 274868Recruiting
Miami, Florida, United States
Rush Md Anderson Cancer Center /ID# 274926Recruiting
Chicago, Illinois, United States
OSF St. Francis Medical Center /ID# 274752Recruiting
Peoria, Illinois, United States
Parkview Research Center /ID# 274338Recruiting
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492Recruiting
Indianapolis, Indiana, United States
Baptist Health Lexington /ID# 275218Recruiting
Lexington, Kentucky, United States
Norton Cancer Institute - St. Matthews /ID# 276173Recruiting
Louisville, Kentucky, United States
Women'S Cancer Care /ID# 276469Recruiting
Covington, Louisiana, United States
University Medical Center New Orleans /ID# 274755Recruiting
New Orleans, Louisiana, United States
Trials 365 /ID# 274310Recruiting
Shreveport, Louisiana, United States
University of Maryland, Baltimore /ID# 275308Recruiting
Baltimore, Maryland, United States
Holy Cross Hospital /ID# 275872Recruiting
Silver Spring, Maryland, United States
University of Minnesota - Minneapolis /ID# 275718Recruiting
Minneapolis, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780Recruiting
Saint Louis Park, Minnesota, United States
Cox Medical Center South /ID# 274826Recruiting
Springfield, Missouri, United States
The Center Of Hope /ID# 274313Recruiting
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center /ID# 274676Recruiting
Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey /ID# 274358Recruiting
New Brunswick, New Jersey, United States
Holy Name Medical Center /ID# 276240Recruiting
Teaneck, New Jersey, United States
Optimum Clinical Research Group /ID# 274583Recruiting
Albuquerque, New Mexico, United States
Imbert Cancer Center /ID# 275634Recruiting
Bay Shore, New York, United States
Northwell Health Cancer Institute At Huntington /ID# 276814Recruiting
Greenlawn, New York, United States
Northwell Health Center for Advanced Medicine. /ID# 275641Recruiting
Lake Success, New York, United States
Northwell Health Queens Cancer Center /ID# 274850Recruiting
Rego Park, New York, United States
University of North Carolina Medical Center /ID# 275307Recruiting
Chapel Hill, North Carolina, United States
East Carolina University - Brody School of Medicine /ID# 275770Recruiting
Greenville, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 276952Recruiting
Winston-Salem, North Carolina, United States
Sanford Fargo Medical Center - Fargo /ID# 275489Recruiting
Fargo, North Dakota, United States
The Mark H Zangmeister Center /ID# 275106Recruiting
Columbus, Ohio, United States
Oncology Associates of Oregon, P.C. /ID# 275006Recruiting
Eugene, Oregon, United States
Northwest Cancer Specialists /ID# 275101Recruiting
Portland, Oregon, United States
St. Lukes University Hospital /ID# 274362Recruiting
Bethlehem, Pennsylvania, United States
University of Pennsylvania /ID# 275612Recruiting
Philadelphia, Pennsylvania, United States
Women & Infants Hospital /ID# 274716Recruiting
Providence, Rhode Island, United States
Sanford Cancer Center /ID# 274901Recruiting
Sioux Falls, South Dakota, United States
Avera Cancer Institute - Sioux Falls /ID# 276226Recruiting
Sioux Falls, South Dakota, United States
Texas Oncology - Austin Central /ID# 275046Recruiting
Austin, Texas, United States
Texas Oncology - Fort Worth Cancer Center /ID# 275043Recruiting
Fort Worth, Texas, United States
Houston Methodist Hospital /ID# 274568Recruiting
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090Recruiting
San Antonio, Texas, United States
Texas Oncology - The Woodlands /ID# 275015Recruiting
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas /ID# 275057Recruiting
Tyler, Texas, United States
UVA Health University Hospital /ID# 275309Recruiting
Charlottesville, Virginia, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456Recruiting
Fairfax, Virginia, United States
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227Recruiting
Norfolk, Virginia, United States
Carilion Roanoke Memorial Hospital /ID# 274684Recruiting
Roanoke, Virginia, United States
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585Recruiting
Spokane, Washington, United States
West Virginia University School of Medicine /ID# 274556Recruiting
Morgantown, West Virginia, United States