Ireland
--:--IST
Recruiting Phase 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.

NCT06890338 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 2
Started
2025-11-21
Last updated
2026-10-20

Condition(s) studied

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerNeoadjuvant

Investigational drug(s) / intervention(s)

Carboplatin →Mirvetuximab Soravtansine →Bevacizumab →

Carboplatin: Intravenous (IV) infusion

Mirvetuximab Soravtansine: Intravenous (IV) infusion

Bevacizumab: Intravenous (IV) infusion (per investigator's discretion)

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective Response (OR) by Independent Central Review (ICR) — Up to Approximately 3 years
    OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).

Trial sites (73)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Hospital /ID# 274793 Birmingham Alabama Recruiting
Usa Mitchell Cancer Institute /ID# 276022 Mobile Alabama Recruiting
Kaiser Permanente - Irvine /ID# 276924 Irvine California Recruiting
UCLA - University of California Los Angeles Medical Center /ID# 274566 Los Angeles California Recruiting
Scripps Md Anderson - Prebys Cancer Center /ID# 276891 San Diego California Recruiting
California Pacific Medical Center - Van Ness Campus /ID# 275329 San Francisco California Recruiting
Ridley Tree Cancer Center /ID# 275219 Santa Barbara California Active Not Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 274783 Danbury Connecticut Recruiting
Yale University School of Medicine /ID# 275794 New Haven Connecticut Recruiting
Norwalk Hospital /ID# 274561 Norwalk Connecticut Recruiting
Jupiter Medical Center /ID# 276616 Jupiter Florida Recruiting
Mount Sinai Medical Center /ID# 274868 Miami Beach Florida Completed
Rush Md Anderson Cancer Center /ID# 274926 Chicago Illinois Recruiting
University of Chicago Medical Center /ID# 274796 Chicago Illinois Recruiting
OSF St. Francis Medical Center /ID# 274752 Peoria Illinois Recruiting
Carle Foundation Hospital /ID# 276470 Urbana Illinois Recruiting
Parkview Research Center /ID# 274338 Fort Wayne Indiana Recruiting
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492 Indianapolis Indiana Recruiting
Baptist Health Lexington /ID# 275218 Lexington Kentucky Recruiting
Norton Cancer Institute - St. Matthews /ID# 276173 Louisville Kentucky Recruiting
Women'S Cancer Care /ID# 276469 Covington Louisiana Recruiting
University Medical Center New Orleans /ID# 274755 New Orleans Louisiana Recruiting
Willis-Knighton Medical Center /ID# 274310 Shreveport Louisiana Recruiting
University of Maryland, Baltimore /ID# 275308 Baltimore Maryland Recruiting
Holy Cross Hospital /ID# 275872 Silver Spring Maryland Recruiting
University of Minnesota - Minneapolis /ID# 275718 Minneapolis Minnesota Recruiting
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780 Saint Louis Park Minnesota Recruiting
University Of Mississippi Medical Center /ID# 276342 Jackson Mississippi Recruiting
Cox Medical Center South /ID# 274826 Springfield Missouri Recruiting
Mercy David C. Pratt Cancer Center /ID# 275655 St Louis Missouri Recruiting
The Center Of Hope /ID# 274313 Reno Nevada Recruiting
Dartmouth-Hitchcock Medical Center /ID# 274676 Lebanon New Hampshire Recruiting
John Theurer Cancer Center /ID# 275756 Hackensack New Jersey Recruiting
Rutgers Cancer Institute of New Jersey /ID# 274358 New Brunswick New Jersey Recruiting
Holy Name Medical Center /ID# 276240 Teaneck New Jersey Recruiting
Optimum Clinical Research Group /ID# 274583 Albuquerque New Mexico Recruiting
Imbert Cancer Center /ID# 275634 Bay Shore New York Recruiting
Northwell Health Cancer Institute At Huntington /ID# 276814 Greenlawn New York Recruiting
Northwell Health Center for Advanced Medicine. /ID# 275641 Lake Success New York Recruiting
Columbia University Irving Medical Center /ID# 276156 New York New York Recruiting

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06890338 on ClinicalTrials.gov ↗ ← All trials in the USA