A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）

Starting soon

Conditions studied: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer

In brief

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.

Key facts

Study ID: NCT07690332
Run by: NING LI-GYN
People needed: 400
Starts: 2026-07-20
Expected to finish: 2028-09-30
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients who meet all of the following inclusion criteria are eligible to participate in the study:
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).
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.
Patients must have had completed any major surgery at least 4 weeks prior to the first dose of MIRV, and have recovered or stabilized from postoperative complications of prior surgery.
Patients must have expected survival of at least 12 weeks as assessed by the investigator.
Patients must sign informed consent form（ICF）, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations.

You may not qualify if…

Patients who meet any of the following criteria may not be enrolled in the study:
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

Full record on ClinicalTrials.gov

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