A Study to Evaluate Adverse Events and Change in Disease Activity of Mirvetuximab Soravtansine-gynx in Adults With Folate Receptor-Alpha Positive, Platinum-Resistant Ovarian Cancer in a Real-World Setting

A Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Mirvetuximab Soravtansine-gynx in Patients With Folate Receptor-Alpha Positive, Platinum-Resistant, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07687602

Enrollment

Registered

2026-07-07

Start date

2026-06-30

Completion date

2031-08-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer

Keywords

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Mirvetuximab Soravtansine-gynx MIRV Elahere

Brief summary

Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea. The purpose of this study is to evaluate the adverse events and change in disease activity of mirvetuximab soravtansine-gynx (MIRV) in participants with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. This study will evaluate the patient outcome in a routine clinical practice setting in South Korea. MIRV is an antibody drug conjugate for high grade serious epithelial ovarian cancer in participants who have received one to three prior systemic treatment regimens. Participants with FRα positive platinum-resistant ovarian cancer who started treatment with MIRV according to the approved product label in Korea will be enrolled. Around 69 participants will be enrolled in the study in South Korea. Participants will receive MIRV according to the approved local label. Participants will be followed for up to 62 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Folate receptor-alpha (FRα) positive (\>=75% of cells with \>=2+ staining intensity) platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens, according to the approved product label

Exclusion criteria

* Participants who are contraindicated from approved label of mirvetuximab soravtansine-gynx (MIRV). * Participants who are currently participating in a clinical trial of another investigational drug.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AE)s	Up to Approximately Up to 62 Months	AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Contacts

CONTACTDaYoung Hwang

dayoung.hwang@abbvie.com844-663-3742

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results