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

Sponsor
NING LI-GYN
Study ID
NCT07690332
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab Soravtansine (MIRV) — DRUG
    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.

Study Details

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 Mirvetuximab Soravtansine in patients of Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer with expression of Folate Receptor α.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 folate receptor alpha (FRα). Data will be collected from medical records of patients who received MIRV as part of their routine clinical care.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: All Enrolled Patients Receiving MIRV-Based Therapy
    This cohort includes all enrolled patients with FRα-expressing advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer who receive mirvetuximab soravtansine (MIRV)-based therapy in routine clinical practice. Patients may receive MIRV as monotherapy or in combination with other anticancer agents per physician's discretion and clinical practice guidelines.

Primary Outcome Measure

Incidence of Grade ≥ 3 Treatment-Related Adverse Events (TRAEs) [ Time Frame: From first dose to 30 days after last dose of MIRV ]

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