A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
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Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
110estimated
Sites
52
Countries
Australia, Belgium, France +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-28 | actual | When the study began enrolling |
| Primary completion | Jul 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced High-Grade Epithelial Ovarian Cancer
- Primary Peritoneal Cancer
- Fallopian Tube Cancers
Intervention
- Drug: Mirvetuximab Soravtansine — also filed as MIRV, IMGN853
Primary outcomes
what the primary-completion date above is the date OFRandomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)
measured Up to Approximately 24 months
Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR)
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine
measured Up to Approximately 24 months
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