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.
NCT ID: NCT06890338
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2025-11-21
2030-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carboplatin + Mirvetuximab Soravtansine
Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.
Carboplatin
Intravenous (IV) infusion
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
Intravenous (IV) infusion (per investigator's discretion)
Interventions
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Carboplatin
Intravenous (IV) infusion
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
Intravenous (IV) infusion (per investigator's discretion)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, 27 and
* Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining by the AbbVie specified vendor with the Ventana Folate Receptor Alpha (FOLR1) assay, and
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham, Alabama, United States
Usa Mitchell Cancer Institute /ID# 276022
Mobile, Alabama, United States
California Pacific Medical Center /ID# 275329
San Francisco, California, United States
Ridley Tree Cancer Center /ID# 275219
Santa Barbara, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 274783
Danbury, Connecticut, United States
Norwalk Hospital /ID# 274561
Norwalk, Connecticut, United States
Jupiter Medical Center /ID# 276616
Jupiter, Florida, United States
Mount Sinai Medical Center /ID# 274868
Miami, Florida, United States
OSF St. Francis Medical Center /ID# 274752
Peoria, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
Indianapolis, Indiana, United States
Women'S Cancer Care /ID# 276469
Covington, Louisiana, United States
University Medical Center New Orleans /ID# 274755
New Orleans, Louisiana, United States
Trials 365 /ID# 274310
Shreveport, Louisiana, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
Saint Louis Park, Minnesota, United States
Cox Medical Center South /ID# 274826
Springfield, Missouri, United States
The Center Of Hope /ID# 274313
Reno, Nevada, United States
Rutgers Cancer Institute of New Jersey /ID# 274358
New Brunswick, New Jersey, United States
Imbert Cancer Center /ID# 275634
Bay Shore, New York, United States
Northwell Health Cancer Institute At Huntington /ID# 276814
Greenlawn, New York, United States
Northwell Health Center for Advanced Medicine. /ID# 275641
Lake Success, New York, United States
Northwell Health Queens Cancer Center /ID# 274850
Rego Park, New York, United States
University of North Carolina Medical Center /ID# 275307
Chapel Hill, North Carolina, United States
The Mark H Zangmeister Center /ID# 275106
Columbus, Ohio, United States
Oncology Associates of Oregon, P.C. /ID# 275006
Eugene, Oregon, United States
Northwest Cancer Specialists /ID# 275101
Portland, Oregon, United States
St. Lukes University Hospital /ID# 274362
Bethlehem, Pennsylvania, United States
University of Pennsylvania /ID# 275612
Philadelphia, Pennsylvania, United States
Women & Infants Hospital /ID# 274716
Providence, Rhode Island, United States
Texas Oncology - Austin Central /ID# 275046
Austin, Texas, United States
Texas Oncology - Fort Worth Cancer Center /ID# 275043
Fort Worth, Texas, United States
Houston Methodist Hospital /ID# 274568
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
San Antonio, Texas, United States
Texas Oncology - The Woodlands /ID# 275015
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas /ID# 275057
Tyler, Texas, United States
UVA Health University Hospital /ID# 275309
Charlottesville, Virginia, United States
Carilion Clinic /ID# 274684
Roanoke, Virginia, United States
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
Spokane, Washington, United States
West Virginia University School of Medicine /ID# 274556
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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GOG-3115
Identifier Type: OTHER
Identifier Source: secondary_id
M25-231
Identifier Type: -
Identifier Source: org_study_id