A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression o… (NCT07690332) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）
400 participantsStarted 2026-07-20
Plain-language summary
Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate approved for the treatment of ovarian cancer. However, real-world data on its safety and effectiveness in routine clinical practice are limited, especially in the Chinese patient population. MIRAS is a multicenter, prospective，observational, real-word study of MIRV in patients of advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα.This study aims to evaluate the real-world safety and efficacy of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer that expresses FRα. Data will be collected from medical records of patients who received MIRV as part of their routine clinical care.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female patients aged ≥18 years.
. Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
. Patients must have PD on or after the most recent anti-cancer therapy.
. Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining).
. Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations
. Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
Timeframe: From first dose to 30 days after last dose of MIRV
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-2.
. All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ grade 1 per common terminology criteria for adverse events （CTCAE）v5.0.
Exclusion criteria
. Participation in other clinical studies during the same period.
. Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients.
. Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision.
. Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort)
. Pregnant or breast-feeding females. Women of childbearing potential must agree to use highly effective contraception while using study drug and for at least 7 months after the last dose of MIRV.
. Current participation in any interventional study other than routine clinical practice.
. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study