PH3 Study of Mirvetuximab Soravtansine vs Investigator's Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer

Official Title

FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Summary:

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 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.

Trial Description

Primary Outcome:

  • Progression free survival in all patients randomized to the study and in patients with high folate receptor alpha expression
Secondary Outcome:
  • Objective response rate (ORR) per RECIST1.1
  • Overall survival (OS) as measured from the date of randomization until the date of death.
  • Quality of life
Patients will be randomized to either IMGN853 or Investigator's Choice chemotherapy.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society