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NCT07690332

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

Sponsor: NING LI-GYN

View on ClinicalTrials.gov

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 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.

Official title: A Real-World Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (MIRV) in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer With Expression of Folate Receptor α

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-07-20

Completion Date

2028-09-30

Last Updated

2026-07-08

Healthy Volunteers

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.

Inclusion Criteria: * Patients who meet all of the following inclusion criteria are eligible to participate in the study: 1. Female patients aged ≥18 years. 2. Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 3. Patients must have PD on or after the most recent anti-cancer therapy. 4. Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining). 5. Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations 6. Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator). 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-2. 8. All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ Grade 1 per CTCAE v5.0. 9. 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. 10. Patients must have expected survival of at least 12 weeks as assessed by the investigator. 11. Patients must sign ICF, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations. Exclusion Criteria: * Patients who meet any of the following criteria may not be enrolled in the study: 1. Participation in other clinical studies during the same period. 2. Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients. 3. 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. 4. Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort) 5. 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. 6. Current participation in any interventional study other than routine clinical practice. 7. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study