A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

PHASE3CompletedINTERVENTIONAL
Enrollment

453

Participants

Timeline

Start Date

December 31, 2019

Primary Completion Date

March 6, 2023

Study Completion Date

October 29, 2024

Conditions
Epithelial Ovarian CancerPeritoneal CancerFallopian Tube Cancer
Interventions
DRUG

Mirvetuximab Soravtansine

Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

DRUG

Paclitaxel

Paclitaxel will be administered per dose and schedule specified in the arm.

DRUG

Topotecan

Topotecan will be administered per dose and schedule specified in the arm.

DRUG

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.

Trial Locations (214)

10

"LLC VitaMed", Moscow

220

Far Eastern Memorial Hospital, New Taipei City

1407

Acibadem City Clinic Tokuda Hospital, Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD, Sofia", Sofia

2031

Prince of Wales Hospital, Randwick

2065

Royal North Shore Hospital, Saint Leonards

2305

Newcastle Private Hospital, New Lambton Heights

2390

AZ Klina, Brasschaat

2650

Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek, Edegem

3000

UZ Leuven, Leuven

3144

Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location, Malvern

3168

Monash Health, Clayton

5065

Burnside War Memorial Hospital - The Brian Fricker Oncology Centre, Toorak Gardens

5800

UMHAT Georgi Stranski, Pleven

6132

Centro Operativo Studi Clinici S.C.Oncologia Medica, Perugia

8000

Complex Oncology Center, Burgas

8208

Parc Taulí, Sabadell

8916

Institut Català d'Oncologia, Badalona

9000

AZ St-Lucas, Ghent

9300

OLV Ziekenhuis, Aalst

10003

H. San Pedro de Alcántara, Cáceres

10032

Columbia University Medical Center, New York

10126

Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino, Torino

10128

Ospedale Mauriziano Umberto I, Torino

10408

National Cancer Center - Center for Uterine Cancer, Gyeonggi-do

10449

Mackay Memorial Hospital - Taipei Branch, Taipei

11000

Oncology and Radiology Institute Serbia, Belgrade

11217

Taipei Veterans General Hospital, Taipei

12002

Hospital Provincial de Castellon, Castelló

13009

Institut Paoli Calmettes, Marseille

13100

Ziv Medical Center, Safed

13620

Seoul National University Bundang Hospital, Seongnam-si

14029

Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council, Chernihiv

15213

Magee-Women's Hospital-UPMC, Pittsburgh

15224

West Penn Hospital, Pittsburgh

15706

Hospital Clínico de Santiago, Santiago de Compostela

18009

"Communal non-profit enterprise Cherkasy Regional Oncology Dispensary of Cherkasy oblast council", Cherkasy

19104

University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20141

IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO), Milan

20155

USOR: Virginia Cancer Specialists, PC, Gainesville

20357

Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg

20902

Holy Cross Hospital, Silver Spring

USOR: Maryland Oncology Hematology, P.A., Silver Spring

21204

Oncology Institute Vojvodina, Surgical Oncology Clinic, Kamenitz

22190

Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO, Plérin

22908

University of Virginia Health System, Charlottesville

23007

H. U. de Jaén, Jaén

23900

ASST Lecco- Ospedale A.Manzoni, Lecco

25030

CHRU Besançon, Besançon

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia

26506

West Virginia University- MBRCC, Morgantown

28050

Hospital de San Chinarro-Clara Campal, Madrid

28374

FirstHealth of the Carolinas Outpatient Cancer Center, Pinehurst

28702

Hospital Universitario Infanta Sofía, San Sebastián de los Reyes

29009

"Communal non-profit enterprise Khmelnytskyi Regional Antitumor Center of Khmelnytskoyi Regional Council", Khmelnytskyi

30120

Hospital Clínico Universitario Virgen de la Arrixaca, Murcia

31059

Institut Claudius Regaud, Toulouse

31404

Memorial University Medical Center, Savannah

32224

Mayo Clinic Jacksonville, Jacksonville

32308

Florida Cancer Specialists, Tallahassee

33076

Institut Bergonie, Bordeaux

33401

Florida Cancer Specialist East Division, West Palm Beach

33701

Women's Care Florida / Women's Cancer Associates, St. Petersburg

33705

Florida Cancer Specialist North Division, St. Petersburg

33901

Florida Cancer Specialist South Division, Fort Myers

34000

Clinical Center Kragujevac, Kragujevac

34239

Sarasota Memorial Hospital, Sarasota

35128

IOV Istituto Oncologico, Padua

35233

University of Alabama at Birmingham (UAB) GYN Oncology, Birmingham

37075

UMG Göttingen Frauenklinik, Göttingen

37203

Tennessee Oncology / Sarah Cannon Research Institute, Nashville

40207

Norton Cancer Institute, Louisville

41013

Virgen del Rocío, Seville

41017

St. Elizabeth Healthcare, Edgewood

42123

Oncologia Azienda Osc-IRCCS Reggio Emilia, Reggio Emilia

43026

The Ohio State University Wexner Medical Center, Hilliard

43215

Columbus NCORP, Columbus

43219

Zangmeister Cancer Center, Columbus

44109

MetroHealth Medical Center, Cleveland

44137

Klinikum Dortmund gGmbH / Frauenklinik, Dortmund

44195

Cleveland Clinic, Cleveland

44805

ICO Centre René Gauducheau, Saint-Herblain

45014

Oncology_Hematology Care Clinical Trials, LLC, Fairfield

45242

USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc., Cincinnati

46026

Hospital de la Fe, Valencia

46250

Community Health Network, Indianapolis

48106

St. Joseph Mercy Hospital, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

49055

Institut de cancérologie de l'ouest, site Angers, Angers

50009

HCU Lozano Blesa, Zaragoza

53127

Universitätsklinikum Bonn, Bonn

54519

Institut de cancérologie de Lorraine, Vandoeuvre Les Nancy_ Cedex

55125

USOR: Minnesota Oncology Hematology, PA, Woodbury

55905

Mayo Clinic Rochester, Rochester

59020

Centre Oscar Lambret, Lille

59405

Sletten Cancer Institute, Great Falls

60005

Illinois Cancer Specialists, Arlington Heights

60521

Dr. Sudarshan K. Sharma, Ltd., Hinsdale

60637

University of Chicago, Chicago

61024

Grigoriev Institute for Medical Radiology NAMS of Ukraine, Kharkiv

64132

HCA Midwest Kansas City/ Sarah Cannon, Kansas City

66205

University of Kansas Cancer Center, Westwood

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

69373

Centre Leon Berard, Lyon

70121

Ochnser Medical Center Jefferson, New Orleans

73104

Stephenson Cancer Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute, Tulsa

75014

Cochin Hospital, Paris

75702

USOR: Texas Oncology - Tyler, Tyler

76018

Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council, Ivano-Frankivsk

76100

Kaplan Medical Center, Rehovot

76104

USOR: Texas Oncology - Fort Worth Cancer Center, Fort Worth

77030

University of Texas, Memorial Hermann, Houston

77380

USOR: Texas Oncology - The Woodlands, Gynecologic Oncology, The Woodlands

77479

USOR: Texas Oncology, P.A., Sugar Land

77598

USOR: Texas Oncology, P.A., Webster

78240

USOR: Texas Oncology - San Antonio, San Antonio

78503

USOR: Texas Oncology - McAllen South Second, McAllen

78745

USOR: Texas Oncology-South Austin, Austin

79106

University Hospital Freiburg, Freiburg im Breisgau

80131

INT Pascale, Naples

80228

USOR: Rocky Mountain Cancer Centers, Lakewood

85016

Arizona Oncology Associates, PC - HAL - USOR, Phoenix

85054

Mayo Clinic, Phoenix

85711

USOR: Arizona Oncology Associates, PC - HOPE, Tucson

85719

University of Arizona Cancer Center, Tucson

89075

Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe, Ulm

89511

Center of Hope, Reno

90095

UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit, Los Angeles

91324

Olive View - UCLA Medical Center, Sylmar

92210

Institut Curie, Saint-Cloud

92663

Hoag Cancer Center, Newport Beach

94143

University of California San Francisco, San Francisco

94589

Kaiser Permanente Oncology Clinical Trials, Vallejo

94805

Gustave Roussy, Villejuif

96813

Hawaii Pacific Health - Kapiolani Medical Center for Women and Children, Honolulu

97210

Legacy Gynecologic Oncology, Portland

97227

USOR: Northwest Cancer Specialists, P.C., Portland

97401

USOR: Willamette Valley Cancer Institute and Research Center, Eugene

99336

Kadlec Clinic Hematology & Oncology, Kennewick

99508

Alaska Women's Cancer Care, Anchorage

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

110801

Liaoning Cancer Hospital, Shenyang

130031

The First Hospital of Jilin University, Changchun

194356

Leningrad regional oncology dispensa, Saint Petersburg

200032

Fudan University Shanghai Cancer Center, Shanghai

215006

The First Affiliated Hospital of Soochow University, Suzhou

230000

Anhui Provincial Cancer Hospital, Hefei

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

350014

Fujian Cancer Hospital, Fuzhou

361004

Zhongshan Hospital Xiamen University, Xiamen

430024

Wuhan Union Hospital of China, Wuhan

430061

Zhongnan Hospital of Wuhan University, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450054

State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan, Ufa

510060

Sun Yat-sen University, Cancer Center, Guangzhou

644013

"BIH of Omsk Region Clinical Oncology Dispensary", Omsk

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

771103

WK Physicians Network/Gynecologic Oncology Associates, Shreveport

4428164

Meir Medical Center, Kfar Saba

5265601

Sheba Medical Center, Ramat Gan

5822012

Wolfson Medical Center, Holon

06520

Yale University School of Medicine, New Haven

02111

Tufts Medical Center, Boston

01199

Baystate Medical Center, Springfield

01605

University of Massachusetts, Worcester

07450

The Valley Hospital, Inc, Ridgewood

07666

Holy Name Medical Center, Teaneck

02905

Women & Infants Hospital of Rhode Island, Providence

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

K1H8L6

The Ottawa Hospital General Campus, Ottawa

M4N 3M5

Sunnybrook Health Sciences Center, Toronto

M5G 2M9

Princess Margaret Cancer Centre - University Health Network, Toronto

H2X 0A9

Centre Hospitalier de L'Universite de Montreal, Montreal

H4A 3J1

McGill University Health Centre, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

708 52

Fakultní nemocnice Ostrava, Ostrava

128 51

Všeobecná fakultní nemocnice v Praze, Prague

762 75

KNTB a.s. Zlín, Zlín

75960 Cedex 20

Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

06847

Städtisches Klinikum Dessau, Zentrum für Klinische Studien, Dessau

Unknown

UKGM Standort Giessen, Giessen

Istituto Oncologico Candiolo, Torino

POB 12000

Hadassah Ein Kerem Medical center, Jerusalem

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

1105 AZ

Amsterdam UMC, Amsterdam

6229 HX

Maastricht UMC, Maastricht

Postbus 9101, 6500 HB

Radboud University Medical Center, Nijmegen

3015 AA

Erasmus Medical Center, Rotterdam

80-214

Medical University of Gdansk, Gdansk

20-081

Samodzielny publiczny szpital kliniczny nr 1, Lublin

10-561

Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne, Olsztyn

61-866

Wielkopolskie Centrum Onkologii, Poznan

00-315

Szpital Kliniczny im. Ks. Anny Mazowieckiej, Warsaw

1400-038

Fundação Champalimaud, Lisbon

1500-650

Hospital da Luz, S.A, Lisbon

1649-028

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

2674-514

Hospital Beatriz Angelo, Loures

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

University of Ulsan College of Medicine - Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

PE3 9GZ

Peterborough City Hospital, Peterborough

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

CV2 2DX

University Hospitals Coventry and Warwickshire, Coventry

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

EC1A 7BE

St Bartholomew's Hospital-Barts Health NHS Trust, London

NW1 2PG

University College London Hospital, London

SM2 5PT

The Royal Marsden NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Gynecologic Oncology Group

NETWORK

collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

lead

AbbVie

INDUSTRY