A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNING LI-GYN
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Mirvetuximab Soravtansine (MIRV)
Treatment groups
400 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
NING LI-GYN
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov