Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer | — | UNRESOLVED | — |
| Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer | — | UNRESOLVED | — |
| Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Mirvetuximab Soravtansine-gynx
- description
- Participants will receive Mirvetuximab Soravtansine-gynx according to the Korean approved label and at the discretion of the treating physician.
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AE)s
- timeFrame
- Up to Approximately Up to 62 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available