A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α(FRα)
NCT07690332 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2026-07-24
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.
Conditions
- Ovarian Cancer
- Fallopian Tube Cancers
- Primary Peritoneal Cancer
Interventions
- DRUG
-
Mirvetuximab Soravtansine (MIRV)
The recommended dose of MIRV is 6 mg/kg based on adjusted ideal body weight (AIBW), administered intravenously on Day 1 of each 21-day cycle. Investigators may adjust the starting dose based on the patient's actual clinical condition. Premedication including antipyretics, antihistamines, corticosteroids, and antiemetics is administered prior to each infusion to reduce infusion-related reactions and gastrointestinal adverse events. Prophylactic corticosteroid eye drops and artificial tears are used to manage ocular toxicity. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first. Dose reductions (to 5 mg/kg or 4 mg/kg AIBW) are permitted for management of adverse events per protocol-specified criteria.
Sponsors & Collaborators
-
NING LI-GYN
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-20
- Primary Completion
- 2028-09-30
- Completion
- 2028-09-30
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