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NCT Number: NCT07687602

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events (AE)s

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DaYoung Hwang

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.