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

Last updated: September 24, 2020
Sponsor: ImmunoGen, Inc.
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Mirvetuximab soravtansine

Paclitaxel

Pegylated liposomal doxorubicin

Clinical Study ID

NCT02631876
IMGN853-0403
  • Ages > 18
  • Female

Study Summary

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be diagnosed with advanced epithelial ovarian cancer, primaryperitoneal cancer or fallopian tube cancer

  • Participants must have folate receptor alpha positive tumor expression as defined inthe protocol

  • Participants must have platinum-resistant ovarian cancer, defined as progressionwithin 6 months from completion of a minimum of four cycles of platinum-containingtherapy.

  • Participants must have received at least one but no more than three prior systemictreatment regimens and for whom single-agent chemotherapy is appropriate as the nextline of treatment

  • Participants must have at least one lesion that meets the definition of measurabledisease by RECIST 1.1

Exclusion

Exclusion Criteria:

  • Diagnosis of clear cell, low grade ovarian cancer or mixed tumors

  • Participants with primary platinum-refractory disease

  • Serious concurrent illness or clinically relevant active infection as defined in theprotocol

  • Prior treatment with mirvetuximab soravtansine

  • Women who are pregnant or breast feeding

Study Design

Total Participants: 366
Treatment Group(s): 4
Primary Treatment: Mirvetuximab soravtansine
Phase: 3
Study Start date:
March 02, 2016
Estimated Completion Date:
January 31, 2020

Study Description

Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.

Connect with a study center

  • Facility St. Augustunus

    Antwerp, Wirijk 2610
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • University Ziekenhuis Dienst Medical Oncologie

    Gent, B-9000
    Belgium

    Site Not Available

  • AZ Groeninge - Oncology Centre

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800
    Belgium

    Site Not Available

  • University Clinical Center of Republic of Srpska

    Banja Luka, 78 000
    Bosnia and Herzegovina

    Site Not Available

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Sunnybrook Research Institute - Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Hopital de la CitedelaSante

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • McGill University Health Centre - Glen Site

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Porodnicka A Gynekologicka Klinika

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • University Hospital Ostrava

    Ostrava Poruba, 708 52
    Czechia

    Site Not Available

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

    Zlín, 76275
    Czechia

    Site Not Available

  • Institut de Cancerologie de L'Ouest - site Paul Papin

    Angers, 49055
    France

    Site Not Available

  • CHRU Jean Minjoz

    Besançon, 25030
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • Cochin Hospital

    Paris, 75014
    France

    Site Not Available

  • Hôpital Croix St-Simon

    Paris, 75020
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol

    Plérin, 22190
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Site Not Available

  • Institut Curie-Hopital Rene Huguenin

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Site Not Available

  • Gustave Roussy Institution

    Villejuif, 94800
    France

    Site Not Available

  • Bon Secours Hospital

    Cork,
    Ireland

    Site Not Available

  • Mater Private Hospital and Mater Misericordiae University Hospital

    Dublin,
    Ireland

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, MI 20141
    Italy

    Site Not Available

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

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Sanitaria Locale (ASL)

    Brindisi, 72100
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale di Ravenna

    Faenza, 48018
    Italy

    Site Not Available

  • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

    Meldola (FC), 47014
    Italy

    Site Not Available

  • Fondazione IRCCS National Cancer Institute

    Milan, 20133
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Istituto Nazionale Tumori- G. Pascale

    Naples, 80131
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • LLC "VitaMed"

    Moscow, 121309
    Russian Federation

    Site Not Available

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

    Novosibirsk, 630108
    Russian Federation

    Site Not Available

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

    Omsk, 644013
    Russian Federation

    Site Not Available

  • State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"

    Saint Petersburg, 191014
    Russian Federation

    Site Not Available

  • Oncology and Radiology Institute Serbia

    Belgrade, 11 000
    Serbia

    Site Not Available

  • Clinical Centre Nis, Oncology Clinic

    Niš, 18 000
    Serbia

    Site Not Available

  • Oncology Institute Vojvodina

    Sremska Kamenica, 21 204
    Serbia

    Site Not Available

  • ICO Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Onkologikoa

    Donostia San Sebastian, Gipuzkoa 20014
    Spain

    Site Not Available

  • Hospital Teresa Herrera (CHUACoruña)

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Vall D'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • IOR - Hospital Quiron Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • Institut Català d'Oncologia - Unitad de Investigación Clínica

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Complejo Hospitalario Granada

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • MD Anderson Cancer Center - Madrid

    Madrid, 28033
    Spain

    Site Not Available

  • Servicio de Oncología Médica Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga

    Malaga, 29011
    Spain

    Site Not Available

  • Hospital Son Llatzer (HSLL)

    Palma de Mallorca, 07198
    Spain

    Site Not Available

  • Instituto Valenciano de Oncologia

    Valencia, 46009
    Spain

    Site Not Available

  • Kantonsspital

    Winterthur, Zurich 8401
    Switzerland

    Site Not Available

  • Kantonsspital Winterthur, Medizinische Onkologie

    Winterthur, Zurich 8401
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve

    Geneve, 1205
    Switzerland

    Site Not Available

  • UCL Cancer Institute

    London, England WC1E 6BT
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, England NG5 1PB
    United Kingdom

    Site Not Available

  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

    Preston, England PR2 9HT
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

    Surrey, England SM2 5PT
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

    Sutton, England SM2 5PT
    United Kingdom

    Site Not Available

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

    Wolverhampton, England WV10 OQP
    United Kingdom

    Site Not Available

  • York Teaching Hospitals NHS foundation Trust

    York, England YO31 8HE
    United Kingdom

    Site Not Available

  • Peterborough City Hospital

    Peterborough, Great Britain PE3 9GZ
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland G12 0YN
    United Kingdom

    Site Not Available

  • Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University

    Stoke-on-Trent, Staffordshire ST4 6QG
    United Kingdom

    Site Not Available

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

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • St. Joseph's Hospital and Medical Center (SJHMC) - Center for Women's Health

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona 85284
    United States

    Site Not Available

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona 85711
    United States

    Site Not Available

  • UCLA Women's Health Clinical Research Unit - OBGYN

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California San Diego Medical Center

    San Diego, California 92093
    United States

    Site Not Available

  • California Pacific Medical Center

    San Francisco, California 94118
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    Vallejo, California 94589
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Norwalk Hospital/WCHN

    Norwalk, Connecticut 06856
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center/UMHC

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida State University College of Medicine

    Sarasota, Florida 34239
    United States

    Site Not Available

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

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60629
    United States

    Site Not Available

  • Sudarshan Sharma LTD

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Loyola University Chicago

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Community Health Network, Inc.

    Indianapolis, Indiana 46184
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • McFarland Clinic

    Ames, Iowa 50010
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Women's Cancer Care

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • WK Physician Network Clinical Research

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Holy Cross Hospital

    Silver Spring, Maryland 20902
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Mercy Women's Oncology

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Center of Hope

    Reno, Nevada 89502
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • MD Anderson Cancer Center - Cooper Health

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Morristown Medical Center Women's Cancer Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)

    New York, New York 10065
    United States

    Site Not Available

  • Levine Cancer Institute - Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Fairview Hospital, Moll Pavilion Cancer Center

    Cleveland, Ohio 44111
    United States

    Site Not Available

  • OSU Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Hillcrest Hospital

    Mayfield, Ohio 44124
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Abington Hospital, Hanjani Institute for Gynecologic Oncology

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Abington Hospital, Hanjani Institute for Gynecologic Oncology

    Abington,, Pennsylvania 19001
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Magee - Womens Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Women & Infants of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Hollings Cancer Center

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Oncology-Austin Central

    Austin, Texas 78731
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Texas Oncology - Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Texas Oncology-Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • Kadlec Clinic Hematology & Oncology

    Kennewick, Washington 99336
    United States

    Site Not Available

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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