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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

NCT04209855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2025-08-27

Study results available
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Summary

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Conditions

Interventions

DRUG

Mirvetuximab Soravtansine

Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

DRUG

Paclitaxel

Paclitaxel will be administered per dose and schedule specified in the arm.

DRUG

Topotecan

Topotecan will be administered per dose and schedule specified in the arm.

DRUG

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2023-03-06
Completion
2024-10-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04209855 on ClinicalTrials.gov