RecruitingPhase 3NCT05445778

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

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

Sponsor

AbbVie

Enrollment

520 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether mirvetuximab soravtansine (a targeted antibody-drug treatment) combined with bevacizumab works better than bevacizumab alone as maintenance therapy in women with platinum-sensitive ovarian, fallopian tube, or peritoneal cancer whose tumors have high levels of a protein called folate receptor alpha (FRα). **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer - Your tumor tests high for the folate receptor alpha (FRα) protein - Your cancer came back after first-line platinum chemotherapy but is still responsive to platinum (platinum-sensitive) - You are willing to use effective contraception **You may NOT be eligible if...** - Your tumor is a different subtype (such as clear cell or mucinous) - You have significant eye problems that could be worsened by the study drug - You are pregnant or breastfeeding - You have certain other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirvetuximab soravtansine plus Bevacizumab

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

DRUGBevacizumab

Participants will receive Bevacizumab 15mg/kg every 3 weeks

Locations(264)

Usa Mitchell Cancer Institute /ID# 269661

Mobile, Alabama, United States

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

Phoenix, Arizona, United States

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

Irvine, California, United States

Moores Cancer Center at UC San Diego /ID# 269564

La Jolla, California, United States

Kaiser Permanente - Los Angeles Medical Center /ID# 269541

Los Angeles, California, United States

University Of California Irvine Medical Center /ID# 269572

Orange, California, United States

Stanford Women'S Cancer Center /ID# 269552

Palo Alto, California, United States

Kaiser Permanente - Riverside Medical Center /ID# 269539

Riverside, California, United States

Kaiser Permanente Zion Medical Center /ID# 269537

San Diego, California, United States

Kaiser Permanente - San Diego Medical Center /ID# 269540

San Diego, California, United States

Kaiser Permanente - San Marcos Medical Offices /ID# 269542

San Marcos, California, United States

Olive View-Ucla Medical Center /ID# 269584

Sylmar, California, United States

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

Walnut Creek, California, United States

Broward General Medical Center /ID# 269577

Fort Lauderdale, Florida, United States

Regional Cancer Center /ID# 269558

Fort Myers, Florida, United States

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

Jacksonville, Florida, United States

Mount Sinai Medical Center /ID# 269582

Miami, Florida, United States

Sarasota Memorial Hospital /ID# 269526

Sarasota, Florida, United States

Northside Hospital /ID# 269660

Atlanta, Georgia, United States

Rush University Medical Center /ID# 269583

Chicago, Illinois, United States

University of Chicago Medical Center /ID# 269546

Chicago, Illinois, United States

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

Indianapolis, Indiana, United States

St. Vincent Indianapolis Hospital /ID# 269107

Indianapolis, Indiana, United States

University of Iowa /ID# 269566

Iowa City, Iowa, United States

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

Westwood, Kansas, United States

Baptist Health Lexington /ID# 269568

Lexington, Kentucky, United States

University of Kentucky Chandler Medical Center. /ID# 269536

Lexington, Kentucky, United States

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

New Orleans, Louisiana, United States

Ochsner Medical Center - Jefferson Highway /ID# 269530

New Orleans, Louisiana, United States

Maine Medical Center - Scarborough Campus /ID# 269555

Scarborough, Maine, United States

Johns Hopkins Hospital /ID# 269579

Baltimore, Maryland, United States

Sinai Hospital Of Baltimore /ID# 269567

Manchester, Maryland, United States

GBMC Cancer Center /ID# 269561

Towson, Maryland, United States

Tufts Medical Center /ID# 269547

Boston, Massachusetts, United States

Baystate Medical Center /ID# 269544

Springfield, Massachusetts, United States

Corewell Health /ID# 269562

Grand Rapids, Michigan, United States

Minnesota Oncology - Coon Rapids Clinic /ID# 269550

Coon Rapids, Minnesota, United States

Nebraska Methodist Hospital /ID# 269580

Omaha, Nebraska, United States

The Center Of Hope /ID# 269528

Reno, Nevada, United States

Dartmouth-Hitchcock Medical Center /ID# 269576

Lebanon, New Hampshire, United States

John Theurer Cancer Center /ID# 269109

Hackensack, New Jersey, United States

The Valley Hospital /ID# 269548

Paramus, New Jersey, United States

Holy Name Medical Center /ID# 269543

Teaneck, New Jersey, United States

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

Albany, New York, United States

Women'S Cancer Care Associates /ID# 269553

Albany, New York, United States

Northwell Health Center for Advanced Medicine. /ID# 269108

Lake Success, New York, United States

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

Mineola, New York, United States

NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556

New York, New York, United States

Icahn School of Medicine at Mount Sinai /ID# 269529

New York, New York, United States

University of North Carolina at Chapel Hill /ID# 269563

Chapel Hill, North Carolina, United States

Duke Cancer Institute /ID# 269557

Durham, North Carolina, United States

University of Cincinnati /ID# 269578

Cincinnati, Ohio, United States

Jamescare Gynecologic Oncology At Mill Run /ID# 269105

Hilliard, Ohio, United States

Kettering Medical Center /ID# 269585

Kettering, Ohio, United States

OU Health - Stephenson Cancer Center /ID# 269525

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute /ID# 269527

Tulsa, Oklahoma, United States

Willamette Valley Cancer Institute and Research Center /ID# 269988

Eugene, Oregon, United States

Compass Oncology - Rose Quarter /ID# 270131

Portland, Oregon, United States

Oregon Health and Science University /ID# 269581

Portland, Oregon, United States

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

Pittsburgh, Pennsylvania, United States

Allegheny Health Network West Penn Hospital /ID# 269551

Pittsburgh, Pennsylvania, United States

Asplundh Cancer Pavilion /ID# 269574

Willow Grove, Pennsylvania, United States

Sanford Cancer Center /ID# 269535

Sioux Falls, South Dakota, United States

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

Germantown, Tennessee, United States

Texas Oncology - Austin Central /ID# 269531

Austin, Texas, United States

Texas Oncology - Bedford /ID# 269571

Bedford, Texas, United States

Texas Oncology - Methodist Dallas Cancer Center /ID# 269554

Dallas, Texas, United States

Texas Oncology - Fort Worth Cancer Center /ID# 269532

Fort Worth, Texas, United States

US Oncology Research Investigational Products Center /ID# 278746

Irving, Texas, United States

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

San Antonio, Texas, United States

University of Virginia Health System /ID# 269545

Charlottesville, Virginia, United States

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

Norfolk, Virginia, United States

VCU Health Adult Outpatient Pavillion /ID# 269570

Richmond, Virginia, United States

Swedish Cancer Institute /ID# 269538

Seattle, Washington, United States

Sanatorio De La Mujer /ID# 269352

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Buenos Aires /ID# 269356

Buenos Aires, Argentina

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

Córdoba, Argentina

Isis Centro Especializado De Luce /ID# 269353

Santa Fe, Argentina

Westmead Hospital /ID# 269362

Westmead, New South Wales, Australia

Gold Coast University Hospital /ID# 269365

Southport, Queensland, Australia

Ballarat Base Hospital /ID# 269364

Ballarat, Victoria, Australia

Monash Health - Monash Medical Centre /ID# 269360

Clayton, Victoria, Australia

Cabrini Hospital Malvern /ID# 269359

Malvern, Victoria, Australia

Peter MacCallum Cancer Centre /ID# 269361

Melbourne, Victoria, Australia

Epworth Hospital /ID# 269363

Richmond, Victoria, Australia

St. John Of God Subiaco Hospital /ID# 269358

Subiaco, Western Australia, Australia

Imelda Ziekenhuis /ID# 269369

Bonheiden, Antwerpen, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 269368

Brussels, Brussels Capital, Belgium

Grand Hôpital De Charleroi - Notre Dame /ID# 269367

Charleroi, Hainaut, Belgium

AZ Sint-Lucas /ID# 269366

Ghent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Leuven /ID# 269370

Leuven, Vlaams-Brabant, Belgium

AZ-Delta. /ID# 269091

Roeselare, West-Vlaanderen, Belgium

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

Namur, Belgium

Hospital Santa Izabel /ID# 269384

Salvador, Estado de Bahia, Brazil

Catarina Pesquisa Clinica /ID# 269379

Itajaí, Santa Catarina, Brazil

Beneficência Portuguesa de São Paulo /ID# 269092

São Paulo, São Paulo, Brazil

Hospital Nove De Julho /ID# 269375

São Paulo, São Paulo, Brazil

Complex Oncology Center - Shumen /ID# 269372

Shumen, Bulgaria

Comprehensive Cancer Center /ID# 269373

Vratsa, Bulgaria

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

Calgary, Alberta, Canada

Cross Cancer Institute /ID# 269392

Edmonton, Alberta, Canada

Bc Cancer Agency - Fraser Valley Centre /ID# 269398

Surrey, British Columbia, Canada

BC Cancer - Vancouver /ID# 269394

Vancouver, British Columbia, Canada

Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396

Hamilton, Ontario, Canada

Kingston General Hospital /ID# 269397

Kingston, Ontario, Canada

The Ottawa Hospital - General Campus /ID# 269391

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre /ID# 269390

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393

Sherbrooke, Quebec, Canada

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Capital Medical University (Cmu)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Province Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital, Sun-Yat Sen University

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Province Cancer Hospital

Changsha, Hunan, China

The First Bethune Hospital Of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital Of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

LinYi Cancer Hospital

Linyi, Shandong, China

Fudan University Cancer Hospital /ID# 271025

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Cancer Hospital Affliated to Xinjiang Medical University

Ürümqi, Xinjiang, China

Yunnan Province Cancer Hospital

Kunming, Yunnan, China

The Affiliated Women'S Hospital Of Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Fakultní Nemocnice Brno - Obilní Trh /ID# 269401

Brno, Brno-mesto, Czechia

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

Prague, Ceske Budejovice, Czechia

Nemocnice Novy Jicin /ID# 269400

Nový Jičín, Novy Jicin, Czechia

Fakultni nemocnice Ostrava /ID# 269403

Ostrava, Ostrava-mesto, Czechia

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

Strasbourg, Bas-Rhin, France

Hôpital La Timone /ID# 269421

Marseille, Bouches-du-Rhone, France

Chu Dijon /Id# 269417

Dijon, Bourgogne-Franche-Comté, France

CHU Brest /ID# 269422

Brest, Finistere, France

Centre Leon Berard /ID# 269418

Lyon, Rhone, France

Institut Curie /ID# 269420

Paris, Île-de-France Region, France

Klinikum Esslingen /ID# 269435

Esslingen am Neckar, Baden-Wurttemberg, Germany

Universitaetsklinikum Heidelberg /ID# 269438

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen /ID# 269439

Erlangen, Bavaria, Germany

Universitaetsklinikum Giessen /ID# 269432

Giessen, Hesse, Germany

Onkologische Schwerpunktpraxis Bielefeld /ID# 269440

Bielefeld, North Rhine-Westphalia, Germany

Universitaetsklinikum Bonn /ID# 269434

Bonn, North Rhine-Westphalia, Germany

Klinikum Dortmund Klinikzentrum Mitte /ID# 269441

Dortmund, North Rhine-Westphalia, Germany

Universitaetsmedizin Mainz /ID# 269442

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 269433

Dresden, Saxony, Germany

Universitaetsklinikum Hamburg-Eppendorf /ID# 269429

Hamburg, Germany

Krankenhaus Jerusalem /ID# 269430

Hamburg, Germany

General Hospital of Athens Alexandra /ID# 269444

Athens, Attica, Greece

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

Panórama, Thessaloniki, Greece

Hygeia Hospital /ID# 270132

Athens, Greece

IASO Hospital /ID# 269443

Marousi, Greece

St James Hospital /ID# 269446

Dublin, Dublin, Ireland

Bon Secours Cork Hospital /ID# 269449

Cork, Ireland

Cork University Hospital /ID# 269451

Cork, Ireland

Beaumont Hospital /ID# 269452

Dublin, Ireland

University Hospital Galway /ID# 269447

Galway, Ireland

Sligo General Hospital /ID# 269448

Sligo, Ireland

Waterford Regional Hospital /ID# 269450

Waterford, Ireland

Edith Wolfson Medical Center /ID# 269461

Holon, Central District, Israel

Meir Medical Center /ID# 269454

Kfar Saba, Central District, Israel

Rabin Medical Center /ID# 269456

Petah Tikva, Central District, Israel

Kaplan Medical Center /ID# 269457

Rehovot, Central District, Israel

The Chaim Sheba Medical Center /ID# 269094

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 269455

Tel Aviv, Tel Aviv, Israel

The Lady Davis Carmel Medical Center /ID# 269453

Haifa, Israel

Shaare Zedek Medical Center /ID# 269459

Jerusalem, Israel

Hadassah Medical Center-Hebrew University /ID# 269458

Jerusalem, Israel

ZIV Medical Center /ID# 269460

Safed, Israel

Azienda Ospedaliero Universitaria Careggi /ID# 269465

Florence, Firenze, Italy

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

Meldola, Forlì-Cesena, Italy

Ente Ospedaliero Ospedali Galliera /ID# 269472

Genoa, Genova, Italy

Ospedale San Martino /ID# 269469

Genoa, Genova, Italy

IRCCS Istituto Clinico Humanitas /ID# 269473

Rozzano, Lombardy, Italy

IRCCS Ospedale San Raffaele /ID# 269475

Milan, Milano, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori /ID# 269477

Milan, Milano, Italy

Casa di Cura San Pio X /ID# 277973

Milan, Milano, Italy

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

Naples, Napoli, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 269470

Rome, Roma, Italy

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

Rome, Roma, Italy

Ospedale di Mirano - Azienda ULSS 3 /ID# 269462

Mirano, Venezia, Italy

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

Bologna, Italy

Ospedale Cannizzaro /ID# 269478

Catania, Italy

Alessandro Manzoni Hospital /ID# 269467

Lecco, Italy

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

Lucca, Italy

Azienda Ospedaliero Universitaria Di Parma /ID# 269466

Parma, Italy

Fondazione IRCCS Policlinico San Matteo /ID# 269463

Pavia, Italy

AUSL Piacenza-Ospedale Guglielmo da Saliceto /ID# 269468

Piacenza, Italy

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

Prato, Italy

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

Reggio Emilia, Italy

Aichi Cancer Center /ID# 274332

Nagoya, Aichi-ken, Japan

Chiba University Hospital /ID# 274371

Chiba, Chiba, Japan

The Jikei University Kashiwa Hospital /ID# 274334

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center /ID# 276078

Matsuyama, Ehime, Japan

Kurume University Hospital /ID# 274337

Kurume-shi, Fukuoka, Japan

Sapporo Medical University Hospital /ID# 274330

Sapporo, Hokkaido, Japan

Hokkaido University Hospital /ID# 274331

Sapporo, Hokkaido, Japan

Hyogo Cancer Center /ID# 274323

Akashi-shi, Hyōgo, Japan

Iwate Medical University Hospital - Yahabacho /ID# 274635

Yahaba, Iwate, Japan

Kagoshima University Hospital /ID# 276081

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital /ID# 274336

Isehara, Kanagawa, Japan

Tohoku University Hospital /ID# 274327

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital /ID# 274329

Niigata, Niigata, Japan

Okayama University Hospital /ID# 274324

Okayama, Okayama-ken, Japan

Kindai University Hospital /ID# 274335

Sakai-shi, Osaka, Japan

Osaka Medical And Pharmaceutical University Hospital /ID# 276079

Takatsuki, Osaka, Japan

Saitama Medical University International Medical Center /ID# 274953

Hidaka, Saitama, Japan

Shizuoka Cancer Center /ID# 274325

Sunto-gun, Shizuoka, Japan

Jichi Medical University Hospital /ID# 274634

Shimotsuke-shi, Tochigi, Japan

National Cancer Center Hospital /ID# 274321

Chuo-Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 274326

Koto-ku, Tokyo, Japan

Keio University Hospital /ID# 276159

Shinjuku-ku, Tokyo, Japan

The Jikei University Hospital /ID# 276160

Tokyo, Japan

The Medical City /ID# 269493

Pasig, National Capital Region, Philippines

East Avenue Medical Center /ID# 269099

Quezon City, National Capital Region, Philippines

Cardinal Santos Medical Center /ID# 269100

San Juan City, National Capital Region, Philippines

Wielkopolskie Centrum Onkologii /ID# 269494

Poznan, Greater Poland Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

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

Siedlce, Masovian Voivodeship, Poland

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

Gdynia, Pomeranian Voivodeship, Poland

National Cancer Center /ID# 269481

Goyang-si, Gyeonggido, South Korea

CHA Bundang Medical Center /ID# 269489

Seongnam, Gyeonggido, South Korea

Seoul National University Bundang Hospital /ID# 269482

Seongnam-si, Gyeonggido, South Korea

Keimyung University Dongsan Hospital /ID# 269488

Daegu, Gyeongsangbuk-do, South Korea

Korea University Anam Hospital /ID# 269486