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Brief Title: Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer
Official Title: 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
Study ID: NCT04274426
Brief 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)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Charite Campus Virchow Klinikum, Berlin, , Germany
Städtische Klinikum Dessau, Dessau, , Germany
Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden, Dresden, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Evangelische Kliniken-Essen-Mitte, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Hamburg Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
ViDia Christliche Kliniken Karlsruhe, Karlsruhe, , Germany
HELIOS Klinikum Krefeld, Krefeld, , Germany
St. Elisabeth-Krankenhaus GmbH, Köln-Hohenlind, , Germany
Klinikum Mannheim, Mannheim, , Germany
OnkoNet Marburg, Marburg, , Germany
Klinikum der Universität München, München, , Germany
Rotkreuzklinikum München, München, , Germany
TU München, Klinikum recht der Isar, München, , Germany
Universitätsklinik Münster, Münster, , Germany
Klinikum Südstadt Rostock, Rostock, , Germany
Universitätsfrauenklinik Ulm, Ulm, , Germany
Name: Philipp Harter
Affiliation: Kliniken Essen-Mitte, Germany
Role: STUDY_CHAIR