A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

March 2, 2016

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2020

Conditions
Epithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerOvarian 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

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin 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.

Trial Locations (131)

1200

Cliniques Universitaires Saint-Luc, Brussels

1205

Hopitaux Universitaires de Geneve, Geneva

6800

Centre Hospitalier de l'Ardenne, Libramont

8401

Kantonsspital Winterthur, Medizinische Onkologie, Winterthur

Kantonsspital, Winterthur

8500

AZ Groeninge - Oncology Centre, Kortrijk

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester), New York

14004

Hospital Reina Sofia, Córdoba

15006

Hospital Teresa Herrera (CHUACoruña), A Coruña

15213

Magee - Womens Hospital of UPMC, Pittsburgh

18014

Complejo Hospitalario Granada, Granada

19104

University of Pennsylvania, Philadelphia

20014

Onkologikoa, Donostia / San Sebastian

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS National Cancer Institute, Milan

20141

Istituto Europeo di Oncologia, Milan

20902

Holy Cross Hospital, Silver Spring

22190

Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol, Plérin

25030

CHRU Jean Minjoz, Besançon

28007

Hospital Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center - Madrid, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28046

Servicio de Oncología Médica Hospital Universitario La Paz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28204

Levine Cancer Institute - Carolinas Medical Center, Charlotte

29011

Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga, Málaga

29425

Hollings Cancer Center, Charleston

30912

Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center, Augusta

31059

Institut Claudius Regaud, Toulouse

33076

Institut Bergonie, Bordeaux

34239

Florida State University College of Medicine, Sarasota

35042

Centre Eugene Marquis, Rennes

35294

University of Alabama at Birmingham, Birmingham

40138

Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna

40241

Norton Cancer Institute, Louisville

43210

OSU Wexner Medical Center, Columbus

44111

Fairview Hospital, Moll Pavilion Cancer Center, Cleveland

44124

Hillcrest Hospital, Mayfield

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati Medical Center, Cincinnati

46009

Instituto Valenciano de Oncologia, Valencia

46184

Community Health Network, Inc., Indianapolis

46202

Indiana University School of Medicine, Indianapolis

47014

Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica, Meldola (FC)

48018

Azienda Unita Sanitaria Locale di Ravenna, Faenza

48201

Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

49055

Institut de Cancerologie de L'Ouest - site Paul Papin, Angers

53226

Froedtert and Medical College of Wisconsin, Milwaukee

54519

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy

60521

Sudarshan Sharma LTD, Hinsdale

60629

Rush University Medical Center, Chicago

65804

Mercy Women's Oncology, Springfield

69495

Centre Hospitalier Lyon-Sud, Pierre-Bénite

70121

Ochsner Clinic Foundation, New Orleans

70433

Women's Cancer Care, Covington

71101

WK Physician Network Clinical Research, Shreveport

72100

Azienda Sanitaria Locale (ASL), Brindisi

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa

75014

Cochin Hospital, Paris

75020

Hôpital Croix St-Simon, Paris

75390

University of Texas Southwestern Medical Center, Dallas

75702

Texas Oncology-Tyler, Tyler

76104

Texas Oncology - Fort Worth, Fort Worth

76275

Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin, Zlín

77380

Texas Oncology - The Woodlands, Gynecologic Oncology, The Woodlands

78731

Texas Oncology-Austin Central, Austin

80131

Istituto Nazionale Tumori- G. Pascale, Naples

85284

Arizona Oncology Associates, PC - HAL, Tempe

85711

Arizona Oncology Associates, PC - HOPE, Tucson

87131

The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center, Albuquerque

89502

Center of Hope, Reno

90095

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

92093

University of California San Diego Medical Center, San Diego

92210

Institut Curie-Hopital Rene Huguenin, Saint-Cloud

94118

California Pacific Medical Center, San Francisco

94589

Kaiser Permanente Medical Center, Vallejo

94800

Gustave Roussy Institution, Villejuif

99336

Kadlec Clinic Hematology & Oncology, Kennewick

121309

"LLC VitaMed", Moscow

191014

"State Budget Institution of Health Leningrad Regional Oncologicacal Dispensary", Saint Petersburg

630108

"State Budget-Funded Healthcare Institution of Novosibirsk Oblast Novosibirsk Oblast Oncology Dispensary", Novosibirsk

644013

"Budget-Funded Healthcare Institution of Omsk Oblast Clinical Oncology Dispensary", Omsk

06520

Yale University School of Medicine, New Haven

06856

Norwalk Hospital/WCHN, Norwalk

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

01605

University of Massachusetts Memorial Medical Center, Worcester

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08103

MD Anderson Cancer Center - Cooper Health, Camden

07901

Overlook Medical Center, Summit

02905

Women & Infants of Rhode Island, Providence

B-3000

Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg, Leuven

78 000

University Clinical Center of Republic of Srpska, Banja Luka

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6A 4L6

London Health Sciences Centre, London

K1H8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute - Odette Cancer Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H7M 3L9

Hopital de la CitedelaSante, Laval

H2X 0A9

Centre hospitalier de l'Université de Montréal, Montreal

H4A 3J1

McGill University Health Centre - Glen Site, Montreal

500 05

Porodnicka A Gynekologicka Klinika, Hradec Králové

708 52

University Hospital Ostrava, Ostrava Poruba

Unknown

Bon Secours Hospital, Cork

Mater Private Hospital and Mater Misericordiae University Hospital, Dublin

00168

Policlinico Universitario Agostino Gemelli, Roma

11 000

Oncology and Radiology Institute Serbia, Belgrade

21 204

Oncology Institute Vojvodina, Kamenitz

18 000

Clinical Centre Nis, Oncology Clinic, Niš

08916

ICO Hospital Germans Trias i Pujol, Badalona

08028

IOR - Hospital Quiron Dexeus, Barcelona

08035

Hospital Vall D'Hebron, Barcelona

08908

Institut Català d'Oncologia - Unitad de Investigación Clínica, Barcelona

07198

Hospital Son Llatzer (HSLL), Palma de Mallorca

WC1E 6BT

UCL Cancer Institute, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham

PR2 9HT

Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital, Preston

SM2 5PT

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH), Sutton

WV10 OQP

The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW, Wolverhampton

PE3 9GZ

Peterborough City Hospital, Peterborough

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

ST4 6QG

Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University, Stoke-on-Trent

CV2 2DX

University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre, Coventry

HA6 2RN

Mount Vernon Cancer Centre, Northwood

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Gynecologic Oncology Group

NETWORK

lead

ImmunoGen, Inc.

INDUSTRY

NCT02631876 - A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer | Biotech Hunter | Biotech Hunter