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

Phase 3 Completed 366 enrolled ImmunoGen, Inc. Gynecologic Oncology Group · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-03-02
Primary completion: 2019-01
Completion: 2020-01

Publications

Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	40 mg/m2	Intravenous
Subject	Mirvetuximab Soravtansine	Other / unclassified	6 mg/kg	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Topotecan	Small molecule	1.25 mg/m2	Intravenous
Subject	Topotecan	Small molecule	4 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications