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

NCT07690332 | Not Yet Recruiting

• 1 other identifier: MIRV-20260305
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)

  Incidence of grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator

  From first dose to 30 days after last dose of MIRV

Secondary Outcomes (6)

• Investigator-assessed objective response rate (ORR)

  From first dose until disease progression, up to approximately 24 months

• Investigator-assessed duration of response (DOR)

  From first documented response to disease progression or death, up to approximately 24 months.

• Investigator-assessed progression-free survival (PFS)

  From first dose to disease progression or death, up to approximately 24 months.

• Overall survival (OS)

  From first dose to death from any cause, up to approximately 36 months.

• CA125 response

  From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months.

Other Outcomes (2)

• MIRV Treatment Patterns

  Baseline and throughout treatment period.

• Progression-Free Survival 2 (PFS2) and Subsequent Therapy

  From first dose to progression on subsequent therapy or death, up to approximately 36 months.

Study Arms (1)

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 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.

Drug: Mirvetuximab Soravtansine (MIRV)

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.

Also known as: Elahere

All enrolled patients receiving MIRV-based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα

You may qualify if:

• 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

Sponsors & Collaborators

• NING LI-GYN: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archival or fresh tumor tissue samples (from surgical resection or biopsy) will be used for FRα expression testing by VENTANA FOLR1 immunohistochemistry assay as part of screening for study eligibility. All tissue samples are obtained through routine clinical practice, not collected specifically for this study. Retained formalin-fixed paraffin-embedded（FFPE）tissue blocks/slides are used solely for FRα testing and will not be stored for future research purposes.

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share