Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)

May 21, 2026 updated by: AbbVie

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Hospital Italiano de Buenos Aires /ID# 269356
      • Córdoba, Argentina, 5004
        • Hospital Italiano de Córdoba (Sociedad de Beneficencia Hospital Italiano) /ID# 269090
      • Santa Fe, Argentina, 3000
        • Isis Centro Especializado De Luce /ID# 269353
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Sanatorio De La Mujer /ID# 269352
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital /ID# 269362
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast University Hospital /ID# 269365
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Base Hospital /ID# 269364
      • Clayton, Victoria, Australia, 3168
        • Monash Health - Monash Medical Centre /ID# 269360
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern /ID# 269359
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre /ID# 269361
      • Richmond, Victoria, Australia, 3121
        • Epworth Hospital /ID# 269363
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St. John Of God Subiaco Hospital /ID# 269358
  • Belgium
      • Namur, Belgium, 5000
        • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 269371
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Imelda Ziekenhuis /ID# 269369
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 269368
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hôpital De Charleroi - Notre Dame /ID# 269367
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • AZ Sint-Lucas /ID# 269366
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 269370
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ-Delta. /ID# 269091
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Hospital Santa Izabel /ID# 269384
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Catarina Pesquisa Clinica /ID# 269379
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01323-001
        • Beneficência Portuguesa de São Paulo /ID# 269092
      • São Paulo, São Paulo, Brazil, 01409-002
        • Hospital Nove De Julho /ID# 269375
  • Bulgaria
      • Shumen, Bulgaria, 9705
        • Complex Oncology Center - Shumen /ID# 269372
      • Vratsa, Bulgaria, 3000
        • Comprehensive Cancer Center /ID# 269373
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E Child Comprehensive Cancer Centre /ID# 269388
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute /ID# 269392
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Bc Cancer Agency - Fraser Valley Centre /ID# 269398
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver /ID# 269394
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital /ID# 269397
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus /ID# 269391
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre /ID# 269390
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395
      • Montreal, Quebec, Canada, H2X 0A9
        • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269387
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre - Glen Site. /ID# 269389
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393
  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affiliated Hospital Of Bengbu Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100069
        • Capital Medical University (Cmu)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Province Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun-Yat Sen University
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen University (Sysu) - Sun Yat-Sen Memorial Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Affiliated Cancer Hospital of Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Province Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130499
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital & Institute
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Jinan, Shandong, China, 250014
        • Qilu Hospital of Shandong University
      • Linyi, Shandong, China, 276001
        • Linyi Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Cancer Hospital /ID# 271025
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Second University Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Cancer Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • Cancer Hospital Affliated to Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Yunnan Province Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310006
        • The Affiliated Women'S Hospital Of Zhejiang University
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 602 00
        • Fakultní Nemocnice Brno - Obilní Trh /ID# 269401
    • Ceske Budejovice
      • Prague, Ceske Budejovice, Czechia, 120 00
        • General University Hospital in Prague, Charles University /ID# 269402
    • Novy Jicin
      • Nový Jičín, Novy Jicin, Czechia, 741 01
        • Nemocnice Novy Jicin /ID# 269400
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 708 52
        • Fakultni nemocnice Ostrava /ID# 269403
  • France
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC) /ID# 269419
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13885
        • Hôpital La Timone /ID# 269421
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • Chu Dijon /Id# 269417
    • Finistere
      • Brest, Finistere, France, 29200
        • CHU Brest /ID# 269422
    • Rhone
      • Lyon, Rhone, France, 69373
        • Centre Leon Berard /ID# 269418
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75248
        • Institut Curie /ID# 269420
  • Germany
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 269429
      • Hamburg, Germany, 20357
        • Krankenhaus Jerusalem /ID# 269430
    • Baden-Wurttemberg
      • Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
        • Klinikum Esslingen /ID# 269435
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitaetsklinikum Heidelberg /ID# 269438
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 269439
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • Universitaetsklinikum Giessen /ID# 269432
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld /ID# 269440
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 269434
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Klinikum Dortmund Klinikzentrum Mitte /ID# 269441
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitaetsmedizin Mainz /ID# 269442
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 269433
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital /ID# 270132
      • Marousi, Greece, 15123
        • IASO Hospital /ID# 269443
    • Attica
      • Athens, Attica, Greece, 11528
        • General Hospital of Athens Alexandra /ID# 269444
    • Thessaloniki
      • Panórama, Thessaloniki, Greece, 55236
        • St. Luke's Hospital S.A. /ID# 269445
  • Ireland
      • Cork, Ireland, T12 DV56
        • Bon Secours Cork Hospital /ID# 269449
      • Cork, Ireland, T12 E8YV
        • Cork University Hospital /ID# 269451
      • Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 269452
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 269447
      • Sligo, Ireland, F91 H684
        • Sligo General Hospital /ID# 269448
      • Waterford, Ireland, X91 ER8E
        • Waterford Regional Hospital /ID# 269450
    • Dublin
      • Dublin, Dublin, Ireland, D08 NHY1
        • St James Hospital /ID# 269446
  • Israel
      • Haifa, Israel, 34362
        • The Lady Davis Carmel Medical Center /ID# 269453
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center /ID# 269459
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 269458
      • Safed, Israel, 1311001
        • ZIV Medical Center /ID# 269460
    • Central District
      • Holon, Central District, Israel, 5822012
        • Edith Wolfson Medical Center /ID# 269461
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center /ID# 269454
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center /ID# 269456
      • Rehovot, Central District, Israel, 7660101
        • Kaplan Medical Center /ID# 269457
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 269094
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 269455
  • Italy
      • Bologna, Italy, 40138
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 269476
      • Catania, Italy, 95126
        • Ospedale Cannizzaro /ID# 269478
      • Lecco, Italy, 23900
        • Alessandro Manzoni Hospital /ID# 269467
      • Lucca, Italy, 55100
        • Azienda USL Toscana Nord Ovest - Ospedale San Luca /ID# 269095
      • Parma, Italy, 43100
        • Azienda Ospedaliero Universitaria Di Parma /ID# 269466
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo /ID# 269463
      • Piacenza, Italy, 29121
        • AUSL Piacenza-Ospedale Guglielmo da Saliceto /ID# 269468
      • Prato, Italy, 59100
        • New Hospital of Prato - S. Stefano /ID# 269464
      • Reggio Emilia, Italy, 42122
        • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 269471
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi /ID# 269465
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 269474
    • Genova
      • Genoa, Genova, Italy, 16128
        • Ente Ospedaliero Ospedali Galliera /ID# 269472
      • Genoa, Genova, Italy, 16132
        • Ospedale San Martino /ID# 269469
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • IRCCS Istituto Clinico Humanitas /ID# 269473
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 269475
      • Milan, Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori /ID# 269477
      • Milan, Milano, Italy, 20159
        • Casa di Cura San Pio X /ID# 277973
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione G. Pascale /ID# 269097
    • Roma
      • Rome, Roma, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 269470
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 269096
    • Venezia
      • Mirano, Venezia, Italy, 30035
        • Ospedale di Mirano - Azienda ULSS 3 /ID# 269462
  • Japan
      • Tokyo, Japan, 105-8461
        • The Jikei University Hospital /ID# 276160
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center /ID# 274332
    • Chiba
      • Chiba, Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 274371
      • Kashiwa, Chiba, Japan, 277-0004
        • The Jikei University Kashiwa Hospital /ID# 274334
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center /ID# 276078
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 274337
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 274330
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 274331
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 673-8558
        • Hyogo Cancer Center /ID# 274323
    • Iwate
      • Yahaba, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital - Yahabacho /ID# 274635
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital /ID# 276081
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 274336
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital /ID# 274327
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 274329
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital /ID# 274324
    • Osaka
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 274335
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Medical And Pharmaceutical University Hospital /ID# 276079
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center /ID# 274953
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center /ID# 274325
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital /ID# 274634
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 274321
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR /ID# 274326
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital /ID# 276159
  • Philippines
    • National Capital Region
      • Pasig, National Capital Region, Philippines, 1600
        • The Medical City /ID# 269493
      • Quezon City, National Capital Region, Philippines, 1104
        • East Avenue Medical Center /ID# 269099
      • San Juan City, National Capital Region, Philippines, 1502
        • Cardinal Santos Medical Center /ID# 269100
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-866
        • Wielkopolskie Centrum Onkologii /ID# 269494
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-348
        • Jagiellonskie Centrum Innowacji Sp. z o.o. /ID# 269497
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 269500
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o. /ID# 269495
  • South Korea
    • Gyeonggido
      • Goyang-si, Gyeonggido, South Korea, 10408
        • National Cancer Center /ID# 269481
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 269489
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 269482
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 269488
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 02841
        • Korea University Anam Hospital /ID# 269486
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 269479
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 269483
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 269480
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital /ID# 269484
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 269487
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 269485
      • Seoul, Seoul Teugbyeolsi, South Korea, 08308
        • Korea University Guro Hospital /ID# 269490
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron /ID# 269406
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 269408
      • Girona, Spain, 17007
        • Hospital Universitari De Girona Doctor Josep Trueta /ID# 269411
      • Madrid, Spain, 28027
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 269405
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 269407
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia /ID# 269412
    • A Coruna
      • A Coruña, A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña /ID# 269414
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 269409
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 270296
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria /ID# 269413
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 269410
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Baskent Universitesi Adana Uyg. Ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 270174
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe University Faculty of Medicine /ID# 269521
      • Ankara, Turkey (Türkiye), 06490
        • Baskent Universitesi Ankara Hastanesi /ID# 269524
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie /ID# 269428
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital /ID# 269424
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Cheltenham General Hospital /ID# 269427
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital /ID# 269426
      • London, Greater London, United Kingdom, SW3 6JJ
        • The Royal Marsden - Chelsea /ID# 269102
      • Northwood, Greater London, United Kingdom, HA6 2RN
        • Mount Vernon Hospital /ID# 269423
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton /ID# 269425
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden - Sutton /ID# 269103
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Usa Mitchell Cancer Institute /ID# 269661
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
    • California
      • Irvine, California, United States, 92618
        • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573
      • La Jolla, California, United States, 92093
        • Moores Cancer Center at UC San Diego /ID# 269564
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente - Los Angeles Medical Center /ID# 269541
      • Orange, California, United States, 92868
        • University Of California Irvine Medical Center /ID# 269572
      • Palo Alto, California, United States, 94304
        • Stanford Women'S Cancer Center /ID# 269552
      • Riverside, California, United States, 92505
        • Kaiser Permanente - Riverside Medical Center /ID# 269539
      • San Diego, California, United States, 92120
        • Kaiser Permanente Zion Medical Center /ID# 269537
      • San Diego, California, United States, 92123
        • Kaiser Permanente - San Diego Medical Center /ID# 269540
      • San Marcos, California, United States, 92069
        • Kaiser Permanente - San Marcos Medical Offices /ID# 269542
      • Sylmar, California, United States, 91342
        • Olive View-Ucla Medical Center /ID# 269584
      • Walnut Creek, California, United States, 94598
        • John Muir Health - Walnut Creek Medical Center /ID# 269575
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center /ID# 269577
      • Fort Myers, Florida, United States, 33905
        • Regional Cancer Center /ID# 269558
      • Jacksonville, Florida, United States, 32207
        • Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560
      • Miami, Florida, United States, 33140
        • Mount Sinai Medical Center /ID# 269582
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital /ID# 269526
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital /ID# 269660
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center /ID# 269583
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center /ID# 269546
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5116
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital /ID# 269107
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa /ID# 269566
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center - Westwood /ID# 269106
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington /ID# 269568
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center. /ID# 269536
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center - New Orleans /ID# 269559
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center - Jefferson Highway /ID# 269530
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center - Scarborough Campus /ID# 269555
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital /ID# 269579
      • Manchester, Maryland, United States, 21215
        • Sinai Hospital Of Baltimore /ID# 269567
      • Towson, Maryland, United States, 21204-6831
        • GBMC Cancer Center /ID# 269561
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1552
        • Tufts Medical Center /ID# 269547
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center /ID# 269544
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health /ID# 269562
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Minnesota Oncology - Coon Rapids Clinic /ID# 269550
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital /ID# 269580
    • Nevada
      • Reno, Nevada, United States, 89511
        • The Center Of Hope /ID# 269528
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 269576
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center /ID# 269109
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital /ID# 269548
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center /ID# 269543
    • New York
      • Albany, New York, United States, 12206-5013
        • New York Oncology Hematology - Albany Cancer Center /ID# 269565
      • Albany, New York, United States, 12208
        • Women'S Cancer Care Associates /ID# 269553
      • Lake Success, New York, United States, 11042
        • Northwell Health Center for Advanced Medicine. /ID# 269108
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates - Mineola /ID# 269534
      • New York, New York, United States, 10016
        • NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai /ID# 269529
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill /ID# 269563
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute /ID# 269557
    • Ohio
      • Cincinnati, Ohio, United States, 45267-2827
        • University of Cincinnati /ID# 269578
      • Hilliard, Ohio, United States, 43026
        • Jamescare Gynecologic Oncology At Mill Run /ID# 269105
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center /ID# 269585
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health - Stephenson Cancer Center /ID# 269525
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute /ID# 269527
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center /ID# 269988
      • Portland, Oregon, United States, 97227
        • Compass Oncology - Rose Quarter /ID# 270131
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University /ID# 269581
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University Of Pittsburgh Medical Center Magee - Womens Hospital /ID# 269659
      • Pittsburgh, Pennsylvania, United States, 15244
        • Allegheny Health Network West Penn Hospital /ID# 269551
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion /ID# 269574
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center /ID# 269535
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center and Research Institute - Germantown /ID# 269569
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin Central /ID# 269531
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford /ID# 269571
      • Dallas, Texas, United States, 75203
        • Texas Oncology - Methodist Dallas Cancer Center /ID# 269554
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth Cancer Center /ID# 269532
      • Irving, Texas, United States, 75063
        • US Oncology Research Investigational Products Center /ID# 278746
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 269549
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0816
        • University of Virginia Health System /ID# 269545
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269533
      • Richmond, Virginia, United States, 23219
        • VCU Health Adult Outpatient Pavillion /ID# 269570
    • Washington
      • Seattle, Washington, United States, 98104-3588
        • Swedish Cancer Institute /ID# 269538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult women >/=18 years old
  2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab

Exclusion Criteria:

  1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
  2. More than one line of prior chemotherapy before current/planned triplet therapy
  3. PD (progressive disease) while on or following platinum-based therapy
  4. Prior or whole-pelvis or wide-field radiotherapy
  5. > Grade 1 peripheral neuropathy
  6. History of or concurrent ocular disorders
  7. Grade 4 thromboembolic events
  8. Not appropriate for bevacizumab treatment
  9. Requiring use of folate-containing supplements
  10. Prior hypersensitivity to monoclonal antibodies
  11. Pregnant or breatfeeding women
  12. Received prior MIRV or other FRα-targeting agents
  13. Untreated or symptomatic central nervous system metastases
  14. History of other malignancy within 3 years prior to signing study consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Drug: Mirvetuximab soravtansine plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Other Names:
  • MIRV
Active Comparator: Arm 2
Bevacizumab monotherapy
Drug: Bevacizumab
Participants will receive Bevacizumab 15mg/kg every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Progression-free survival (PFS)
Time Frame: Up to 4 years
Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Overall survival (OS)
Time Frame: Up to 10 years
Overall survival (OS), defined as the time from randomization to death
Up to 10 years
Assess Safety and tolerability
Time Frame: Up to 10 years
Adverse events (AEs) will be evaluated according to the NCI CTCAE v5
Up to 10 years
Assess time to second disease progression (PFS2)
Time Frame: Up to 10 years
Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first
Up to 10 years
Assess Objective Response Rate (ORR)
Time Frame: Up to 10 years
Objective response includes best response of complete response (CR) or partial response (PR).
Up to 10 years
Assess Duration of response (DOR)
Time Frame: Up to 10 years
DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy"
Up to 10 years
Assess Disease-free survival (DFS)
Time Frame: Up to 10 years
DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization
Up to 10 years
CA-125 response
Time Frame: Up to 10 years
Serum CA-125 response determined using the GCIG criteria
Up to 10 years
Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical).
Time Frame: Up to 10 years
A questionnaire assessing the health of patients with ovarian cancer.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

GOG Foundation

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

May 1, 2032

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN853-0421
  • 2022-501606-35 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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