Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85016, United States
Irvine, California 92618, United States
Los Angeles, California 90027, United States
San Marcos, California 92069, United States
Walnut Creek, California 94598, United States
Jacksonville, Florida 32207, United States
Indianapolis, Indiana 46202-5116, United States
New Orleans, Louisiana 70112, United States
Albany, New York 12206-5013, United States
Lake Success, New York 11042, United States
Mineola, New York 11501, United States
Chapel Hill, North Carolina 27514, United States
Eugene, Oregon 97401, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15244, United States
Germantown, Tennessee 38138, United States
San Antonio, Texas 78240, United States
Norfolk, Virginia 23502, United States
Córdoba, 5004, Argentina
Prague, Ceske Budejovice 120 00, Czechia
Strasbourg, Bas-Rhin 67000, France
Bielefeld, North Rhine-Westphalia 33604, Germany
Holon, Central District 5822012, Israel
Meldola, Forlì-Cesena 47014, Italy
Rome, Roma 00168, Italy
Kurume-shi, Fukuoka 830-0011, Japan
Akashi-shi, Hyōgo 673-8558, Japan
Sakai-shi, Osaka 590-0197, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Chuo-Ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Krakow, Lesser Poland Voivodeship 30-348, Poland
Siedlce, Masovian Voivodeship 08-110, Poland
Daegu, Gyeongsangbuk-do 42601, South Korea
Seoul, Seoul Teugbyeolsi 03722, South Korea
Seoul, Seoul Teugbyeolsi 06591, South Korea
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Adana, 01120, Turkey (Türkiye)