NCT05456685

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

Multicenter, Open-label, Phase 2 Study of Carboplatin Plus Mirvetuximab Soravtansine Followed by Mirvetuximab Soravtansine Continuation in FRα Positive, Recurrent Platinum-sensitive, High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Following 1 Prior Line of Platinum-based Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

Detailed description

This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive participants with recurrent platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles), participants without progressive disease will continue on single-agent MIRV. Participants must have confirmation of FRα positivity by the Ventana folate receptor 1 (FOLR1) Assay.

Conditions

• High Grade Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Mirvetuximab soravtansine	Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called FRα. It is being developed for the treatment of participants with recurrent platinum-sensitive, high grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with FRα expression. FRα positivity will be defined by the Ventana FOLR1 Assay.
DRUG	Carboplatin	Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.

Timeline

• Start date: 2022-09-28
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-07-13
• Last updated: 2025-10-28

Locations

69 sites across 6 countries: United States, Belgium, Canada, Georgia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study