AzTrials
AzTrials

Ovarian CancerPhase 3GLORIOSANCT05445778

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

A Phase 3 study testing Mirvetuximab soravtansine plus Bevacizumab and Bevacizumab in people with Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 264 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab soravtansine plus Bevacizumab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
264 sitesin 22 countries
Study dates
15 Mar 2023to May 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women >/=18 years old
  • Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  • Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  • Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  • 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

Who cannot join

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

Trial locations and contacts

264 sites in 22 countries.

264 sites in 22 countries

United States74 sites

  • New York Oncology Hematology - Albany Cancer Center /ID# 269565

    Albany, New York, 12206-5013

  • Women'S Cancer Care Associates /ID# 269553

    Albany, New York, 12208

  • Northside Hospital /ID# 269660

    Atlanta, Georgia, 30342

  • Texas Oncology - Austin Central /ID# 269531

    Austin, Texas, 78731

  • Johns Hopkins Hospital /ID# 269579

    Baltimore, Maryland, 21287

  • Texas Oncology - Bedford /ID# 269571

    Bedford, Texas, 76022

  • Tufts Medical Center /ID# 269547

    Boston, Massachusetts, 02111-1552

  • University of North Carolina at Chapel Hill /ID# 269563

    Chapel Hill, North Carolina, 27514

  • University of Virginia Health System /ID# 269545

    Charlottesville, Virginia, 22908-0816

  • Rush University Medical Center /ID# 269583

    Chicago, Illinois, 60612

  • University of Chicago Medical Center /ID# 269546

    Chicago, Illinois, 60637

  • University of Cincinnati /ID# 269578

    Cincinnati, Ohio, 45267-2827

  • Minnesota Oncology - Coon Rapids Clinic /ID# 269550

    Coon Rapids, Minnesota, 55433

  • Texas Oncology - Methodist Dallas Cancer Center /ID# 269554

    Dallas, Texas, 75203

  • Duke Cancer Institute /ID# 269557

    Durham, North Carolina, 27710

  • Willamette Valley Cancer Institute and Research Center /ID# 269988

    Eugene, Oregon, 97401

  • Broward General Medical Center /ID# 269577

    Fort Lauderdale, Florida, 33316

  • Regional Cancer Center /ID# 269558

    Fort Myers, Florida, 33905

  • Texas Oncology - Fort Worth Cancer Center /ID# 269532

    Fort Worth, Texas, 76104

  • West Cancer Center and Research Institute - Germantown /ID# 269569

    Germantown, Tennessee, 38138

  • Corewell Health /ID# 269562

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center /ID# 269109

    Hackensack, New Jersey, 07601

  • Jamescare Gynecologic Oncology At Mill Run /ID# 269105

    Hilliard, Ohio, 43026

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110

    Indianapolis, Indiana, 46202-5116

  • St. Vincent Indianapolis Hospital /ID# 269107

    Indianapolis, Indiana, 46260

  • University of Iowa /ID# 269566

    Iowa City, Iowa, 52242

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573

    Irvine, California, 92618

  • US Oncology Research Investigational Products Center /ID# 278746

    Irving, Texas, 75063

  • Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560

    Jacksonville, Florida, 32207

  • Kettering Medical Center /ID# 269585

    Kettering, Ohio, 45429

  • Moores Cancer Center at UC San Diego /ID# 269564

    La Jolla, California, 92093

  • Northwell Health Center for Advanced Medicine. /ID# 269108

    Lake Success, New York, 11042

  • Dartmouth-Hitchcock Medical Center /ID# 269576

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington /ID# 269568

    Lexington, Kentucky, 40503

  • University of Kentucky Chandler Medical Center. /ID# 269536

    Lexington, Kentucky, 40536

  • Kaiser Permanente - Los Angeles Medical Center /ID# 269541

    Los Angeles, California, 90027

  • Sinai Hospital Of Baltimore /ID# 269567

    Manchester, Maryland, 21215

  • Mount Sinai Medical Center /ID# 269582

    Miami, Florida, 33140

  • Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates - Mineola /ID# 269534

    Mineola, New York, 11501

  • Usa Mitchell Cancer Institute /ID# 269661

    Mobile, Alabama, 36604

  • Louisiana State University Health Sciences Center - New Orleans /ID# 269559

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center - Jefferson Highway /ID# 269530

    New Orleans, Louisiana, 70121

  • NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai /ID# 269529

    New York, New York, 10029

  • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269533

    Norfolk, Virginia, 23502

  • OU Health - Stephenson Cancer Center /ID# 269525

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital /ID# 269580

    Omaha, Nebraska, 68114

  • University Of California Irvine Medical Center /ID# 269572

    Orange, California, 92868

  • Stanford Women'S Cancer Center /ID# 269552

    Palo Alto, California, 94304

  • The Valley Hospital /ID# 269548

    Paramus, New Jersey, 07652

  • Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987

    Phoenix, Arizona, 85016

  • University Of Pittsburgh Medical Center Magee - Womens Hospital /ID# 269659

    Pittsburgh, Pennsylvania, 15213

  • Allegheny Health Network West Penn Hospital /ID# 269551

    Pittsburgh, Pennsylvania, 15244

  • Compass Oncology - Rose Quarter /ID# 270131

    Portland, Oregon, 97227

  • Oregon Health and Science University /ID# 269581

    Portland, Oregon, 97239

  • The Center Of Hope /ID# 269528

    Reno, Nevada, 89511

  • VCU Health Adult Outpatient Pavillion /ID# 269570

    Richmond, Virginia, 23219

  • Kaiser Permanente - Riverside Medical Center /ID# 269539

    Riverside, California, 92505

  • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 269549

    San Antonio, Texas, 78240

  • Kaiser Permanente Zion Medical Center /ID# 269537

    San Diego, California, 92120

  • Kaiser Permanente - San Diego Medical Center /ID# 269540

    San Diego, California, 92123

  • Kaiser Permanente - San Marcos Medical Offices /ID# 269542

    San Marcos, California, 92069

  • Sarasota Memorial Hospital /ID# 269526

    Sarasota, Florida, 34239

  • Maine Medical Center - Scarborough Campus /ID# 269555

    Scarborough, Maine, 04074

  • Swedish Cancer Institute /ID# 269538

    Seattle, Washington, 98104-3588

  • Sanford Cancer Center /ID# 269535

    Sioux Falls, South Dakota, 57104

  • Baystate Medical Center /ID# 269544

    Springfield, Massachusetts, 01199

  • Olive View-Ucla Medical Center /ID# 269584

    Sylmar, California, 91342

  • Holy Name Medical Center /ID# 269543

    Teaneck, New Jersey, 07666

  • GBMC Cancer Center /ID# 269561

    Towson, Maryland, 21204-6831

  • Oklahoma Cancer Specialists and Research Institute /ID# 269527

    Tulsa, Oklahoma, 74146

  • John Muir Health - Walnut Creek Medical Center /ID# 269575

    Walnut Creek, California, 94598

  • The University of Kansas Cancer Center - Westwood /ID# 269106

    Westwood, Kansas, 66205

  • Asplundh Cancer Pavilion /ID# 269574

    Willow Grove, Pennsylvania, 19090

Other trials in United States

China26 sites

  • Capital Medical University (Cmu)

    Beijing, Beijing Municipality, 100069

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233000

  • The First Bethune Hospital Of Jilin University

    Changchun, Jilin, 130499

  • Hunan Province Cancer Hospital

    Changsha, Hunan, 410013

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • Fujian Province Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital, Sun-Yat Sen University

    Guangzhou, Guangdong, 510080

  • Sun Yat-Sen University (Sysu) - Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong, 510120

  • The Affiliated Women'S Hospital Of Zhejiang University

    Hangzhou, Zhejiang, 310006

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Qilu Hospital Of Shandong University

    Jinan, Shandong, 250014

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Province Cancer Hospital

    Kunming, Yunnan, 650106

  • LinYi Cancer Hospital

    Linyi, Shandong, 276001

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Fudan University Cancer Hospital /ID# 271025

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Cancer Hospital Affliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

Other trials in China

Japan23 sites

  • Hyogo Cancer Center /ID# 274323

    Akashi-shi, Hyōgo, 673-8558

  • Chiba University Hospital /ID# 274371

    Chiba, Chiba, 260-8677

  • National Cancer Center Hospital /ID# 274321

    Chuo-Ku, Tokyo, 104-0045

  • Saitama Medical University International Medical Center /ID# 274953

    Hidaka, Saitama, 350-1298

  • Tokai University Hospital /ID# 274336

    Isehara, Kanagawa, 259-1193

  • Kagoshima University Hospital /ID# 276081

    Kagoshima, Kagoshima-ken, 890-8520

  • The Jikei University Kashiwa Hospital /ID# 274334

    Kashiwa, Chiba, 277-0004

  • The Cancer Institute Hospital Of JFCR /ID# 274326

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital /ID# 274337

    Kurume-shi, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center /ID# 276078

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center /ID# 274332

    Nagoya, Aichi-ken, 464-8681

  • Niigata University Medical & Dental Hospital /ID# 274329

    Niigata, Niigata, 951-8520

  • Okayama University Hospital /ID# 274324

    Okayama, Okayama-ken, 700-8558

  • Kindai University Hospital /ID# 274335

    Sakai-shi, Osaka, 590-0197

  • Sapporo Medical University Hospital /ID# 274330

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital /ID# 274331

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 274327

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital /ID# 274634

    Shimotsuke-shi, Tochigi, 329-0498

  • Keio University Hospital /ID# 276159

    Shinjuku-ku, Tokyo, 160-8582

  • Shizuoka Cancer Center /ID# 274325

    Sunto-gun, Shizuoka, 411-8777

  • Osaka Medical And Pharmaceutical University Hospital /ID# 276079

    Takatsuki, Osaka, 569-8686

  • The Jikei University Hospital /ID# 276160

    Tokyo, 105-8461

  • Iwate Medical University Hospital - Yahabacho /ID# 274635

    Yahaba, Iwate, 028-3695

Other trials in Japan

Italy21 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 269476

    Bologna, 40138

  • Ospedale Cannizzaro /ID# 269478

    Catania, 95126

  • Azienda Ospedaliero Universitaria Careggi /ID# 269465

    Florence, Firenze, 50134

  • Ente Ospedaliero Ospedali Galliera /ID# 269472

    Genoa, Genova, 16128

  • Ospedale San Martino /ID# 269469

    Genoa, Genova, 16132

  • Alessandro Manzoni Hospital /ID# 269467

    Lecco, 23900

  • Azienda USL Toscana Nord Ovest - Ospedale San Luca /ID# 269095

    Lucca, 55100

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 269474

    Meldola, Forlì-Cesena, 47014

  • IRCCS Ospedale San Raffaele /ID# 269475

    Milan, Milano, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori /ID# 269477

    Milan, Milano, 20133

  • Casa di Cura San Pio X /ID# 277973

    Milan, Milano, 20159

  • Ospedale di Mirano - Azienda ULSS 3 /ID# 269462

    Mirano, Venezia, 30035

  • Istituto Nazionale Tumori Irccs Fondazione G. Pascale /ID# 269097

    Naples, Napoli, 80131

  • Azienda Ospedaliero Universitaria Di Parma /ID# 269466

    Parma, 43100

  • Fondazione IRCCS Policlinico San Matteo /ID# 269463

    Pavia, 27100

  • AUSL Piacenza-Ospedale Guglielmo da Saliceto /ID# 269468

    Piacenza, 29121

  • New Hospital of Prato - S. Stefano /ID# 269464

    Prato, 59100

  • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 269471

    Reggio Emilia, 42122

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 269470

    Rome, Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 269096

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 269473

    Rozzano, Lombardy, 20089

Other trials in Italy

Canada12 sites

  • Arthur J.E Child Comprehensive Cancer Centre /ID# 269388

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute /ID# 269392

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396

    Hamilton, Ontario, L8V 5C2

  • Kingston General Hospital /ID# 269397

    Kingston, Ontario, K7L 2V7

  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 269395

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269387

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre - Glen Site. /ID# 269389

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital - General Campus /ID# 269391

    Ottawa, Ontario, K1H 8L6

  • CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393

    Sherbrooke, Quebec, J1H 5N4

  • Bc Cancer Agency - Fraser Valley Centre /ID# 269398

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret Cancer Centre /ID# 269390

    Toronto, Ontario, M5G 2M9

  • BC Cancer - Vancouver /ID# 269394

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

South Korea12 sites

  • Keimyung University Dongsan Hospital /ID# 269488

    Daegu, Gyeongsangbuk-do, 42601

  • National Cancer Center /ID# 269481

    Goyang-si, Gyeonggido, 10408

  • CHA Bundang Medical Center /ID# 269489

    Seongnam, Gyeonggido, 13496

  • Seoul National University Bundang Hospital /ID# 269482

    Seongnam-si, Gyeonggido, 13620

  • Korea University Anam Hospital /ID# 269486

    Seoul, Seoul Teugbyeolsi, 02841

  • Seoul National University Hospital /ID# 269479

    Seoul, Seoul Teugbyeolsi, 03080

  • Yonsei University Health System Severance Hospital /ID# 269483

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center /ID# 269480

    Seoul, Seoul Teugbyeolsi, 05505

  • Gangnam Severance Hospital /ID# 269484

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 269487

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 269485

    Seoul, Seoul Teugbyeolsi, 06591

  • Korea University Guro Hospital /ID# 269490

    Seoul, Seoul Teugbyeolsi, 08308

Other trials in South Korea

Germany11 sites

  • Onkologische Schwerpunktpraxis Bielefeld /ID# 269440

    Bielefeld, North Rhine-Westphalia, 33604

  • Universitaetsklinikum Bonn /ID# 269434

    Bonn, North Rhine-Westphalia, 53127

  • Klinikum Dortmund Klinikzentrum Mitte /ID# 269441

    Dortmund, North Rhine-Westphalia, 44137

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 269433

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen /ID# 269439

    Erlangen, Bavaria, 91054

  • Klinikum Esslingen /ID# 269435

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Universitaetsklinikum Giessen /ID# 269432

    Giessen, Hesse, 35392

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 269429

    Hamburg, 20246

  • Krankenhaus Jerusalem /ID# 269430

    Hamburg, 20357

  • Universitaetsklinikum Heidelberg /ID# 269438

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsmedizin Mainz /ID# 269442

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Spain11 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 269414

    A Coruña, A Coruna, 15006

  • Hospital Universitari Vall d'Hebron /ID# 269406

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 269408

    Barcelona, 08036

  • Hospital Universitario Reina Sofia /ID# 270296

    Córdoba, Cordoba, 14004

  • Hospital Universitari De Girona Doctor Josep Trueta /ID# 269411

    Girona, 17007

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 269409

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 269405

    Madrid, 28027

  • Hospital Universitario La Paz /ID# 269407

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria /ID# 269413

    Málaga, Malaga, 29010

  • Clinica Universidad de Navarra - Pamplona /ID# 269410

    Pamplona, Navarre, 31008

  • Hospital Clínico Universitario de Valencia /ID# 269412

    Valencia, 46010

Other trials in Spain

Israel10 sites

  • The Lady Davis Carmel Medical Center /ID# 269453

    Haifa, 34362

  • Edith Wolfson Medical Center /ID# 269461

    Holon, Central District, 5822012

  • Shaare Zedek Medical Center /ID# 269459

    Jerusalem, 9103102

  • Hadassah Medical Center-Hebrew University /ID# 269458

    Jerusalem, 91120

  • Meir Medical Center /ID# 269454

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center /ID# 269456

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 269094

    Ramat Gan, Tel Aviv, 5265601

  • Kaplan Medical Center /ID# 269457

    Rehovot, Central District, 7660101

  • ZIV Medical Center /ID# 269460

    Safed, 1311001

  • Tel Aviv Sourasky Medical Center /ID# 269455

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Australia8 sites

  • Ballarat Base Hospital /ID# 269364

    Ballarat, Victoria, 3350

  • Monash Health - Monash Medical Centre /ID# 269360

    Clayton, Victoria, 3168

  • Cabrini Hospital Malvern /ID# 269359

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre /ID# 269361

    Melbourne, Victoria, 3000

  • Epworth Hospital /ID# 269363

    Richmond, Victoria, 3121

  • Gold Coast University Hospital /ID# 269365

    Southport, Queensland, 4215

  • St. John Of God Subiaco Hospital /ID# 269358

    Subiaco, Western Australia, 6008

  • Westmead Hospital /ID# 269362

    Westmead, New South Wales, 2145

Other trials in Australia

United Kingdom8 sites

  • Cheltenham General Hospital /ID# 269427

    Cheltenham, Gloucestershire, GL53 7AN

  • Guy's Hospital /ID# 269426

    London, Greater London, SE1 9RT

  • The Royal Marsden - Chelsea /ID# 269102

    London, Greater London, SW3 6JJ

  • The Christie /ID# 269428

    Manchester, M20 4BX

  • Mount Vernon Hospital /ID# 269423

    Northwood, Greater London, HA6 2RN

  • University Hospital Southampton /ID# 269425

    Southampton, Hampshire, SO16 6YD

  • The Royal Marsden - Sutton /ID# 269103

    Sutton, Surrey, SM2 5PT

  • Singleton Hospital /ID# 269424

    Swansea, SA2 8QA

Other trials in United Kingdom

Belgium7 sites

  • Imelda Ziekenhuis /ID# 269369

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires UCL Saint-Luc /ID# 269368

    Brussels, Brussels Capital, 1200

  • Grand Hôpital De Charleroi - Notre Dame /ID# 269367

    Charleroi, Hainaut, 6000

  • AZ Sint-Lucas /ID# 269366

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 269370

    Leuven, Vlaams-Brabant, 3000

  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 269371

    Namur, 5000

  • AZ-Delta. /ID# 269091

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Ireland7 sites

  • Bon Secours Cork Hospital /ID# 269449

    Cork, T12 DV56

  • Cork University Hospital /ID# 269451

    Cork, T12 E8YV

  • St James Hospital /ID# 269446

    Dublin, Dublin, D08 NHY1

  • Beaumont Hospital /ID# 269452

    Dublin, D09 XR63

  • University Hospital Galway /ID# 269447

    Galway, H91 YR71

  • Sligo General Hospital /ID# 269448

    Sligo, F91 H684

  • Waterford Regional Hospital /ID# 269450

    Waterford, X91 ER8E

Other trials in Ireland

France6 sites

  • CHU Brest /ID# 269422

    Brest, Finistere, 29200

  • Chu Dijon /Id# 269417

    Dijon, Bourgogne-Franche-Comté, 21000

  • Centre Leon Berard /ID# 269418

    Lyon, Rhone, 69373

  • Hôpital La Timone /ID# 269421

    Marseille, Bouches-du-Rhone, 13885

  • Institut Curie /ID# 269420

    Paris, Île-de-France Region, 75248

  • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC) /ID# 269419

    Strasbourg, Bas-Rhin, 67000

Other trials in France

Argentina4 sites

  • Hospital Italiano de Buenos Aires /ID# 269356

    Buenos Aires, 1181

  • Hospital Italiano de Córdoba (Sociedad de Beneficencia Hospital Italiano) /ID# 269090

    Córdoba, 5004

  • Sanatorio De La Mujer /ID# 269352

    Rosario, Santa Fe Province, 2000

  • Isis Centro Especializado De Luce /ID# 269353

    Santa Fe, 3000

Other trials in Argentina

Brazil4 sites

  • Catarina Pesquisa Clinica /ID# 269379

    Itajaí, Santa Catarina, 88301-220

  • Hospital Santa Izabel /ID# 269384

    Salvador, Estado de Bahia, 40050-410

  • Beneficência Portuguesa de São Paulo /ID# 269092

    São Paulo, São Paulo, 01323-001

  • Hospital Nove De Julho /ID# 269375

    São Paulo, São Paulo, 01409-002

Other trials in Brazil

Czechia4 sites

  • Fakultní Nemocnice Brno - Obilní Trh /ID# 269401

    Brno, Brno-mesto, 602 00

  • Nemocnice Novy Jicin /ID# 269400

    Nový Jičín, Novy Jicin, 741 01

  • Fakultni nemocnice Ostrava /ID# 269403

    Ostrava, Ostrava-mesto, 708 52

  • General University Hospital in Prague, Charles University /ID# 269402

    Prague, Ceske Budejovice, 120 00

Other trials in Czechia

Greece4 sites

  • General Hospital of Athens Alexandra /ID# 269444

    Athens, Attica, 11528

  • Hygeia Hospital /ID# 270132

    Athens, 15123

  • IASO Hospital /ID# 269443

    Marousi, 15123

  • St. Luke's Hospital S.A. /ID# 269445

    Panórama, Thessaloniki, 55236

Other trials in Greece

Poland4 sites

  • Szpitale Pomorskie Sp. z o.o. /ID# 269495

    Gdynia, Pomeranian Voivodeship, 81-519

  • Jagiellonskie Centrum Innowacji Sp. z o.o. /ID# 269497

    Krakow, Lesser Poland Voivodeship, 30-348

  • Wielkopolskie Centrum Onkologii /ID# 269494

    Poznan, Greater Poland Voivodeship, 61-866

  • Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 269500

    Siedlce, Masovian Voivodeship, 08-110

Other trials in Poland

Philippines3 sites

  • The Medical City /ID# 269493

    Pasig, National Capital Region, 1600

  • East Avenue Medical Center /ID# 269099

    Quezon City, National Capital Region, 1104

  • Cardinal Santos Medical Center /ID# 269100

    San Juan City, National Capital Region, 1502

Other trials in Philippines

Turkey (Türkiye)3 sites

  • Baskent Universitesi Adana Uyg. Ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 270174

    Adana, 01120

  • Hacettepe University Faculty of Medicine /ID# 269521

    Ankara, 06230

  • Baskent Universitesi Ankara Hastanesi /ID# 269524

    Ankara, 06490

Other trials in Turkey (Türkiye)

Bulgaria2 sites

  • Complex Oncology Center - Shumen /ID# 269372

    Shumen, 9705

  • Comprehensive Cancer Center /ID# 269373

    Vratsa, 3000

Other trials in Bulgaria

About this study

Official title: 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.

Read the 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.

Being tested
Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Keywords
Platinum-sensitive, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive, High-Grade Ovarian, ADC, Adult
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab soravtansine plus BevacizumabDrug

    Also called MIRV

    Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks

  • BevacizumabDrug

    Participants will receive Bevacizumab 15mg/kg every 3 weeks

Study groups in NCT05445778
Study groupRoleWhat they receive
Arm 1ExperimentalMirvetuximab Soravtansine (MIRV) plus Bevacizumab
Receives: Drug: Mirvetuximab soravtansine plus Bevacizumab
Arm 2Active comparatorBevacizumab monotherapy
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess Progression-free survival (PFS)

    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

    Measured: Up to 4 years

Secondary outcomes (8)

  1. Assess Overall survival (OS)

    Overall survival (OS), defined as the time from randomization to death

    Measured: Up to 10 years

  2. Assess Safety and tolerability

    Adverse events (AEs) will be evaluated according to the NCI CTCAE v5

    Measured: Up to 10 years

  3. Assess time to second disease progression (PFS2)

    Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first

    Measured: Up to 10 years

  4. Assess Objective Response Rate (ORR)

    Objective response includes best response of complete response (CR) or partial response (PR).

    Measured: Up to 10 years

  5. Assess Duration of response (DOR)

    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"

    Measured: Up to 10 years

  6. Assess Disease-free survival (DFS)

    DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization

    Measured: Up to 10 years

  7. CA-125 response

    Serum CA-125 response determined using the GCIG criteria

    Measured: Up to 10 years

  8. 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).

    A questionnaire assessing the health of patients with ovarian cancer.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start15 Mar 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionMay 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445778
Sponsor's protocol ID
IMGN853-0421
Other IDs
2022-501606-35
Acronym
GLORIOSA
Status last verified
May 2026
First submitted
30 Jun 2022
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • O'Malley DM, Myers T, Wimberger P, Van Gorp T, Redondo A, Cibula D, Nicum S, Rodrigues M, Backes FJ, Barlin JN, Lewin SN, Lim P, Pothuri B, Diver E, Banerjee S, Lorusso D. Maintenance with mirvetuximab soravtansine plus bevacizumab vs bevacizumab in FRalpha-high platinum-sensitive ovarian cancer. Future Oncol. 2024;20(32):2423-2436. doi: 10.1080/14796694.2024.2372241. Epub 2024 Jul 31.

    PubMed 39082675

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirvetuximab soravtansine plus Bevacizumab and Bevacizumab in people with Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 264 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 264 sites in United States, China, Japan, Italy, Canada and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess Progression-free survival (PFS) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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