Actively Recruiting
A Single-Arm Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine for Women With FRb1-Expressing Advanced Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Led by AbbVie · Updated on 2026-05-29
140
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in adult women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FRb1. This single-arm Phase 2 study focuses on patients with stage III or IV disease who have measurable tumors and high FRb1 expression. The investigational drug mirvetuximab soravtansine is designed to target and kill cancer cells carrying this receptor. Participants will receive intravenous infusions of mirvetuximab soravtansine combined with carboplatin on the first day of each 21-day cycle. Bevacizumab may also be given based on the investigators decision. This treatment will continue for 6 to 9 cycles over the course of the study, which is expected to last approximately three years. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, and scans to monitor their response to treatment and any side effects. Researchers will evaluate tumor response through imaging and other measures over up to three years, also tracking disease control, progression-free survival, and symptom changes. Safety will be closely monitored throughout the study period.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Diagnosed with biopsy-confirmed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Stage III or IV disease by the FIGO staging system
- Folate Receptor Alpha (FRb1) expression in at least 75% of tumor cells with moderate or higher membrane staining as tested by Ventana FOLR1 assay
- Measurable disease by RECIST Version 1.1 criteria
- Judged by investigator or treating physician to be appropriate for neoadjuvant chemotherapy
You will not qualify if you...
- Tumor types including endometrioid, clear cell, mucinous, sarcomatous histology, mixed tumors containing these types, or low-grade/borderline ovarian tumors
- History of noninfectious interstitial lung disease or pneumonitis
- Prior anticancer therapy for current cancer except one cycle of carboplatin
- Certain eye conditions including history of corneal transplantation, recent or active eye surgeries, severe corneal disease, uncontrolled glaucoma, wet age-related macular degeneration, diabetic retinopathy with macular edema, macular degeneration, papilledema, or risk of retinal detachment
- Monocular vision with visual acuity worse than 20/200 or visual fields less than 20 degrees
- History of other malignancies within 3 years before consent, except for certain low-risk skin or cervical cancers
Research Team
A
ABBVIE CALL CENTER
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