NCT04274426

Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer

A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy. Supported by: DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventana No. RD004881; Protocol Document No. D152967

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: AGO Research GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, two-arm, open-label, comparative phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible for platinum-based chemotherapy.

Detailed description

136 patients will be randomized into the follow-ing two treatment arms as specified below: Arm A: Control arm Platinum-based chemotherapy Arm B: Carboplatin + Mirvetuximab soravtansine (IMGN853)

Conditions

• Recurrent Epithelial Ovarian, Fallopian or Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin will administered by intravenous route
DRUG	Pegylated liposomal doxorubicin (PLD)	PLD will be administered by intravenous route
DRUG	Gemcitabine	Gemcitabine will be administered by intravenous route
DRUG	Paclitaxel	Paclitaxel will be administered by intravenous route
DRUG	Mirvetuximab Soravtansine	Mirvetuximab Soravtansine will be administered by intravenous route

Timeline

• Start date: 2021-10-13
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2020-02-18
• Last updated: 2025-04-06

Locations

19 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study