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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer

NCT02631876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2020-10-14

Study results available
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Summary

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

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

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin 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.

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • ImmunoGen, Inc.

    lead INDUSTRY

Principal Investigators

  • CMO ImmunoGen · ImmunoGen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-02
Primary Completion
2019-01-31
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • Czechia
  • France
  • Ireland
  • Italy
  • Russia
  • Serbia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02631876 on ClinicalTrials.gov