NCT05445778

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
520

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
71mo left

Started Mar 2023

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach
22 countries

264 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Mar 2023May 2032

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

June 30, 2022

Last Update Submit

May 29, 2026

Conditions

Keywords

Platinum-sensitiveFolate-receptor alpha expressionAntibody-drug conjugateCancerOvarian NeoplasmaRecurrent Platinum-SensitiveHigh-Grade OvarianADCAdult

Outcome Measures

Primary Outcomes (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

    Up to 4 years

Secondary Outcomes (8)

  • Assess Overall survival (OS)

    Up to 10 years

  • Assess Safety and tolerability

    Up to 10 years

  • Assess time to second disease progression (PFS2)

    Up to 10 years

  • Assess Objective Response Rate (ORR)

    Up to 10 years

  • Assess Duration of response (DOR)

    Up to 10 years

  • +3 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Mirvetuximab Soravtansine (MIRV) plus Bevacizumab

Drug: Mirvetuximab soravtansine plus Bevacizumab

Arm 2

ACTIVE COMPARATOR

Bevacizumab monotherapy

Drug: Bevacizumab

Interventions

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

Also known as: MIRV
Arm 1

Participants will receive Bevacizumab 15mg/kg every 3 weeks

Arm 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (264)

Usa Mitchell Cancer Institute /ID# 269661

Mobile, Alabama, 36604, United States

Location

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

Phoenix, Arizona, 85016, United States

Location

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

Irvine, California, 92618, United States

Location

Moores Cancer Center at UC San Diego /ID# 269564

La Jolla, California, 92093, United States

Location

Kaiser Permanente - Los Angeles Medical Center /ID# 269541

Los Angeles, California, 90027, United States

Location

University Of California Irvine Medical Center /ID# 269572

Orange, California, 92868, United States

Location

Stanford Women'S Cancer Center /ID# 269552

Palo Alto, California, 94304, United States

Location

Kaiser Permanente - Riverside Medical Center /ID# 269539

Riverside, California, 92505, United States

Location

Kaiser Permanente Zion Medical Center /ID# 269537

San Diego, California, 92120, United States

Location

Kaiser Permanente - San Diego Medical Center /ID# 269540

San Diego, California, 92123, United States

Location

Kaiser Permanente - San Marcos Medical Offices /ID# 269542

San Marcos, California, 92069, United States

Location

Olive View-Ucla Medical Center /ID# 269584

Sylmar, California, 91342, United States

Location

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

Walnut Creek, California, 94598, United States

Location

Broward General Medical Center /ID# 269577

Fort Lauderdale, Florida, 33316, United States

Location

Regional Cancer Center /ID# 269558

Fort Myers, Florida, 33905, United States

Location

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

Jacksonville, Florida, 32207, United States

Location

Mount Sinai Medical Center /ID# 269582

Miami, Florida, 33140, United States

Location

Sarasota Memorial Hospital /ID# 269526

Sarasota, Florida, 34239, United States

Location

Northside Hospital /ID# 269660

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center /ID# 269583

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center /ID# 269546

Chicago, Illinois, 60637, United States

Location

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

Indianapolis, Indiana, 46202-5116, United States

Location

St. Vincent Indianapolis Hospital /ID# 269107

Indianapolis, Indiana, 46260, United States

Location

University of Iowa /ID# 269566

Iowa City, Iowa, 52242, United States

Location

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

Westwood, Kansas, 66205, United States

Location

Baptist Health Lexington /ID# 269568

Lexington, Kentucky, 40503, United States

Location

University of Kentucky Chandler Medical Center. /ID# 269536

Lexington, Kentucky, 40536, United States

Location

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

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center - Jefferson Highway /ID# 269530

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center - Scarborough Campus /ID# 269555

Scarborough, Maine, 04074, United States

Location

Johns Hopkins Hospital /ID# 269579

Baltimore, Maryland, 21287, United States

Location

Sinai Hospital Of Baltimore /ID# 269567

Manchester, Maryland, 21215, United States

Location

GBMC Cancer Center /ID# 269561

Towson, Maryland, 21204-6831, United States

Location

Tufts Medical Center /ID# 269547

Boston, Massachusetts, 02111-1552, United States

Location

Baystate Medical Center /ID# 269544

Springfield, Massachusetts, 01199, United States

Location

Corewell Health /ID# 269562

Grand Rapids, Michigan, 49503, United States

Location

Minnesota Oncology - Coon Rapids Clinic /ID# 269550

Coon Rapids, Minnesota, 55433, United States

Location

Nebraska Methodist Hospital /ID# 269580

Omaha, Nebraska, 68114, United States

Location

The Center Of Hope /ID# 269528

Reno, Nevada, 89511, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 269576

Lebanon, New Hampshire, 03756, United States

Location

John Theurer Cancer Center /ID# 269109

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital /ID# 269548

Paramus, New Jersey, 07652, United States

Location

Holy Name Medical Center /ID# 269543

Teaneck, New Jersey, 07666, United States

Location

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

Albany, New York, 12206-5013, United States

Location

Women'S Cancer Care Associates /ID# 269553

Albany, New York, 12208, United States

Location

Northwell Health Center for Advanced Medicine. /ID# 269108

Lake Success, New York, 11042, United States

Location

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

Mineola, New York, 11501, United States

Location

NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai /ID# 269529

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill /ID# 269563

Chapel Hill, North Carolina, 27514, United States

Location

Duke Cancer Institute /ID# 269557

Durham, North Carolina, 27710, United States

Location

University of Cincinnati /ID# 269578

Cincinnati, Ohio, 45267-2827, United States

Location

Jamescare Gynecologic Oncology At Mill Run /ID# 269105

Hilliard, Ohio, 43026, United States

Location

Kettering Medical Center /ID# 269585

Kettering, Ohio, 45429, United States

Location

OU Health - Stephenson Cancer Center /ID# 269525

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute /ID# 269527

Tulsa, Oklahoma, 74146, United States

Location

Willamette Valley Cancer Institute and Research Center /ID# 269988

Eugene, Oregon, 97401, United States

Location

Compass Oncology - Rose Quarter /ID# 270131

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University /ID# 269581

Portland, Oregon, 97239, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Allegheny Health Network West Penn Hospital /ID# 269551

Pittsburgh, Pennsylvania, 15244, United States

Location

Asplundh Cancer Pavilion /ID# 269574

Willow Grove, Pennsylvania, 19090, United States

Location

Sanford Cancer Center /ID# 269535

Sioux Falls, South Dakota, 57104, United States

Location

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

Germantown, Tennessee, 38138, United States

Location

Texas Oncology - Austin Central /ID# 269531

Austin, Texas, 78731, United States

Location

Texas Oncology - Bedford /ID# 269571

Bedford, Texas, 76022, United States

Location

Texas Oncology - Methodist Dallas Cancer Center /ID# 269554

Dallas, Texas, 75203, United States

Location

Texas Oncology - Fort Worth Cancer Center /ID# 269532

Fort Worth, Texas, 76104, United States

Location

US Oncology Research Investigational Products Center /ID# 278746

Irving, Texas, 75063, United States

Location

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

San Antonio, Texas, 78240, United States

Location

University of Virginia Health System /ID# 269545

Charlottesville, Virginia, 22908-0816, United States

Location

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

Norfolk, Virginia, 23502, United States

Location

VCU Health Adult Outpatient Pavillion /ID# 269570

Richmond, Virginia, 23219, United States

Location

Swedish Cancer Institute /ID# 269538

Seattle, Washington, 98104-3588, United States

Location

Sanatorio De La Mujer /ID# 269352

Rosario, Santa Fe Province, 2000, Argentina

Location

Hospital Italiano de Buenos Aires /ID# 269356

Buenos Aires, 1181, Argentina

Location

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

Córdoba, 5004, Argentina

Location

Isis Centro Especializado De Luce /ID# 269353

Santa Fe, 3000, Argentina

Location

Westmead Hospital /ID# 269362

Westmead, New South Wales, 2145, Australia

Location

Gold Coast University Hospital /ID# 269365

Southport, Queensland, 4215, Australia

Location

Ballarat Base Hospital /ID# 269364

Ballarat, Victoria, 3350, Australia

Location

Monash Health - Monash Medical Centre /ID# 269360

Clayton, Victoria, 3168, Australia

Location

Cabrini Hospital Malvern /ID# 269359

Malvern, Victoria, 3144, Australia

Location

Peter MacCallum Cancer Centre /ID# 269361

Melbourne, Victoria, 3000, Australia

Location

Epworth Hospital /ID# 269363

Richmond, Victoria, 3121, Australia

Location

St. John Of God Subiaco Hospital /ID# 269358

Subiaco, Western Australia, 6008, Australia

Location

Imelda Ziekenhuis /ID# 269369

Bonheiden, Antwerpen, 2820, Belgium

Location

Cliniques Universitaires UCL Saint-Luc /ID# 269368

Brussels, Brussels Capital, 1200, Belgium

Location

Grand Hôpital De Charleroi - Notre Dame /ID# 269367

Charleroi, Hainaut, 6000, Belgium

Location

AZ Sint-Lucas /ID# 269366

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 269370

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ-Delta. /ID# 269091

Roeselare, West-Vlaanderen, 8800, Belgium

Location

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

Namur, 5000, Belgium

Location

Hospital Santa Izabel /ID# 269384

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Catarina Pesquisa Clinica /ID# 269379

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Beneficência Portuguesa de São Paulo /ID# 269092

São Paulo, São Paulo, 01323-001, Brazil

Location

Hospital Nove De Julho /ID# 269375

São Paulo, São Paulo, 01409-002, Brazil

Location

Complex Oncology Center - Shumen /ID# 269372

Shumen, 9705, Bulgaria

Location

Comprehensive Cancer Center /ID# 269373

Vratsa, 3000, Bulgaria

Location

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

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute /ID# 269392

Edmonton, Alberta, T6G 1Z2, Canada

Location

Bc Cancer Agency - Fraser Valley Centre /ID# 269398

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer - Vancouver /ID# 269394

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre - Hamilton Health Sciences /ID# 269396

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston General Hospital /ID# 269397

Kingston, Ontario, K7L 2V7, Canada

Location

The Ottawa Hospital - General Campus /ID# 269391

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre /ID# 269390

Toronto, Ontario, M5G 2M9, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2X 0A9, Canada

Location

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

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS Estrie - Sherbrooke University Hospital Center /ID# 269393

Sherbrooke, Quebec, J1H 5N4, Canada

Location

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233000, China

Location

Capital Medical University (Cmu)

Beijing, Beijing Municipality, 100069, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Province Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital, Sun-Yat Sen University

Guangzhou, Guangdong, 510080, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Province Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Bethune Hospital Of Jilin University

Changchun, Jilin, 130499, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Qilu Hospital Of Shandong University

Jinan, Shandong, 250014, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

LinYi Cancer Hospital

Linyi, Shandong, 276001, China

Location

Fudan University Cancer Hospital /ID# 271025

Shanghai, Shanghai Municipality, 200032, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

Location

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Cancer Hospital Affliated to Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

Yunnan Province Cancer Hospital

Kunming, Yunnan, 650106, China

Location

The Affiliated Women'S Hospital Of Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Fakultní Nemocnice Brno - Obilní Trh /ID# 269401

Brno, Brno-mesto, 602 00, Czechia

Location

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

Prague, Ceske Budejovice, 120 00, Czechia

Location

Nemocnice Novy Jicin /ID# 269400

Nový Jičín, Novy Jicin, 741 01, Czechia

Location

Fakultni nemocnice Ostrava /ID# 269403

Ostrava, Ostrava-mesto, 708 52, Czechia

Location

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

Strasbourg, Bas-Rhin, 67000, France

Location

Hôpital La Timone /ID# 269421

Marseille, Bouches-du-Rhone, 13885, France

Location

Chu Dijon /Id# 269417

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

CHU Brest /ID# 269422

Brest, Finistere, 29200, France

Location

Centre Leon Berard /ID# 269418

Lyon, Rhone, 69373, France

Location

Institut Curie /ID# 269420

Paris, Île-de-France Region, 75248, France

Location

Klinikum Esslingen /ID# 269435

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Universitaetsklinikum Heidelberg /ID# 269438

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Erlangen /ID# 269439

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Giessen /ID# 269432

Giessen, Hesse, 35392, Germany

Location

Onkologische Schwerpunktpraxis Bielefeld /ID# 269440

Bielefeld, North Rhine-Westphalia, 33604, Germany

Location

Universitaetsklinikum Bonn /ID# 269434

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Klinikum Dortmund Klinikzentrum Mitte /ID# 269441

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

Universitaetsmedizin Mainz /ID# 269442

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 269433

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 269429

Hamburg, 20246, Germany

Location

Krankenhaus Jerusalem /ID# 269430

Hamburg, 20357, Germany

Location

General Hospital of Athens Alexandra /ID# 269444

Athens, Attica, 11528, Greece

Location

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

Panórama, Thessaloniki, 55236, Greece

Location

Hygeia Hospital /ID# 270132

Athens, 15123, Greece

Location

IASO Hospital /ID# 269443

Marousi, 15123, Greece

Location

St James Hospital /ID# 269446

Dublin, Dublin, D08 NHY1, Ireland

Location

Bon Secours Cork Hospital /ID# 269449

Cork, T12 DV56, Ireland

Location

Cork University Hospital /ID# 269451

Cork, T12 E8YV, Ireland

Location

Beaumont Hospital /ID# 269452

Dublin, D09 XR63, Ireland

Location

University Hospital Galway /ID# 269447

Galway, H91 YR71, Ireland

Location

Sligo General Hospital /ID# 269448

Sligo, F91 H684, Ireland

Location

Waterford Regional Hospital /ID# 269450

Waterford, X91 ER8E, Ireland

Location

Edith Wolfson Medical Center /ID# 269461

Holon, Central District, 5822012, Israel

Location

Meir Medical Center /ID# 269454

Kfar Saba, Central District, 4428164, Israel

Location

Rabin Medical Center /ID# 269456

Petah Tikva, Central District, 4941492, Israel

Location

Kaplan Medical Center /ID# 269457

Rehovot, Central District, 7660101, Israel

Location

The Chaim Sheba Medical Center /ID# 269094

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 269455

Tel Aviv, Tel Aviv, 6423906, Israel

Location

The Lady Davis Carmel Medical Center /ID# 269453

Haifa, 34362, Israel

Location

Shaare Zedek Medical Center /ID# 269459

Jerusalem, 9103102, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 269458

Jerusalem, 91120, Israel

Location

ZIV Medical Center /ID# 269460

Safed, 1311001, Israel

Location

Azienda Ospedaliero Universitaria Careggi /ID# 269465

Florence, Firenze, 50134, Italy

Location

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

Meldola, Forlì-Cesena, 47014, Italy

Location

Ente Ospedaliero Ospedali Galliera /ID# 269472

Genoa, Genova, 16128, Italy

Location

Ospedale San Martino /ID# 269469

Genoa, Genova, 16132, Italy

Location

IRCCS Istituto Clinico Humanitas /ID# 269473

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Ospedale San Raffaele /ID# 269475

Milan, Milano, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori /ID# 269477

Milan, Milano, 20133, Italy

Location

Casa di Cura San Pio X /ID# 277973

Milan, Milano, 20159, Italy

Location

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

Naples, Napoli, 80131, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 269470

Rome, Roma, 00161, Italy

Location

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

Rome, Roma, 00168, Italy

Location

Ospedale di Mirano - Azienda ULSS 3 /ID# 269462

Mirano, Venezia, 30035, Italy

Location

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

Bologna, 40138, Italy

Location

Ospedale Cannizzaro /ID# 269478

Catania, 95126, Italy

Location

Alessandro Manzoni Hospital /ID# 269467

Lecco, 23900, Italy

Location

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

Lucca, 55100, Italy

Location

Azienda Ospedaliero Universitaria Di Parma /ID# 269466

Parma, 43100, Italy

Location

Fondazione IRCCS Policlinico San Matteo /ID# 269463

Pavia, 27100, Italy

Location

AUSL Piacenza-Ospedale Guglielmo da Saliceto /ID# 269468

Piacenza, 29121, Italy

Location

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

Prato, 59100, Italy

Location

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

Reggio Emilia, 42122, Italy

Location

Aichi Cancer Center /ID# 274332

Nagoya, Aichi-ken, 464-8681, Japan

Location

Chiba University Hospital /ID# 274371

Chiba, Chiba, 260-8677, Japan

Location

The Jikei University Kashiwa Hospital /ID# 274334

Kashiwa, Chiba, 277-0004, Japan

Location

National Hospital Organization Shikoku Cancer Center /ID# 276078

Matsuyama, Ehime, 791-0280, Japan

Location

Kurume University Hospital /ID# 274337

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Sapporo Medical University Hospital /ID# 274330

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital /ID# 274331

Sapporo, Hokkaido, 060-8648, Japan

Location

Hyogo Cancer Center /ID# 274323

Akashi-shi, Hyōgo, 673-8558, Japan

Location

Iwate Medical University Hospital - Yahabacho /ID# 274635

Yahaba, Iwate, 028-3695, Japan

Location

Kagoshima University Hospital /ID# 276081

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Tokai University Hospital /ID# 274336

Isehara, Kanagawa, 259-1193, Japan

Location

Tohoku University Hospital /ID# 274327

Sendai, Miyagi, 980-8574, Japan

Location

Niigata University Medical & Dental Hospital /ID# 274329

Niigata, Niigata, 951-8520, Japan

Location

Okayama University Hospital /ID# 274324

Okayama, Okayama-ken, 700-8558, Japan

Location

Kindai University Hospital /ID# 274335

Sakai-shi, Osaka, 590-0197, Japan

Location

Osaka Medical And Pharmaceutical University Hospital /ID# 276079

Takatsuki, Osaka, 569-8686, Japan

Location

Saitama Medical University International Medical Center /ID# 274953

Hidaka, Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center /ID# 274325

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Jichi Medical University Hospital /ID# 274634

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

National Cancer Center Hospital /ID# 274321

Chuo-Ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital Of JFCR /ID# 274326

Koto-ku, Tokyo, 135-8550, Japan

Location

Keio University Hospital /ID# 276159

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

The Jikei University Hospital /ID# 276160

Tokyo, 105-8461, Japan

Location

The Medical City /ID# 269493

Pasig, National Capital Region, 1600, Philippines

Location

East Avenue Medical Center /ID# 269099

Quezon City, National Capital Region, 1104, Philippines

Location

Cardinal Santos Medical Center /ID# 269100

San Juan City, National Capital Region, 1502, Philippines

Location

Wielkopolskie Centrum Onkologii /ID# 269494

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 30-348, Poland

Location

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

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

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

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

National Cancer Center /ID# 269481

Goyang-si, Gyeonggido, 10408, South Korea

Location

CHA Bundang Medical Center /ID# 269489

Seongnam, Gyeonggido, 13496, South Korea

Location

Seoul National University Bundang Hospital /ID# 269482

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Keimyung University Dongsan Hospital /ID# 269488

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Korea University Anam Hospital /ID# 269486

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Seoul National University Hospital /ID# 269479

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 269483

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center /ID# 269480

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Gangnam Severance Hospital /ID# 269484

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

Samsung Medical Center /ID# 269487

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Korea University Guro Hospital /ID# 269490

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

Complejo Hospitalario Universitario A Coruña /ID# 269414

A Coruña, A Coruna, 15006, Spain

Location

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

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Reina Sofia /ID# 270296

Córdoba, Cordoba, 14004, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 269413

Málaga, Malaga, 29010, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 269410

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari Vall d'Hebron /ID# 269406

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona /ID# 269408

Barcelona, 08036, Spain

Location

Hospital Universitari De Girona Doctor Josep Trueta /ID# 269411

Girona, 17007, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 269405

Madrid, 28027, Spain

Location

Hospital Universitario La Paz /ID# 269407

Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Valencia /ID# 269412

Valencia, 46010, Spain

Location

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

Adana, 01120, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine /ID# 269521

Ankara, 06230, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi /ID# 269524

Ankara, 06490, Turkey (Türkiye)

Location

Cheltenham General Hospital /ID# 269427

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Location

Guy's Hospital /ID# 269426

London, Greater London, SE1 9RT, United Kingdom

Location

The Royal Marsden - Chelsea /ID# 269102

London, Greater London, SW3 6JJ, United Kingdom

Location

Mount Vernon Hospital /ID# 269423

Northwood, Greater London, HA6 2RN, United Kingdom

Location

University Hospital Southampton /ID# 269425

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

The Royal Marsden - Sutton /ID# 269103

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Christie /ID# 269428

Manchester, M20 4BX, United Kingdom

Location

Singleton Hospital /ID# 269424

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsNeoplasms

Interventions

mirvetuximab soravtansineBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

March 15, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2032

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access Criteria
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
More information

Locations