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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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NCT06682988

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

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
DateFiledBasisWhat it is
Start2025-05-28actualWhen the study began enrolling
Primary completionJul 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionApr 2028estimatedThe whole study's end, after follow-up
First posted2024-11-12actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-26actualThe 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 OF
Randomized 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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