Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
Study ID: NCT02631876
Study Description
Brief 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.
Detailed Description: Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL, Tempe, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
UCLA Women's Health Clinical Research Unit - OBGYN, Los Angeles, California, United States
University of California San Diego Medical Center, San Diego, California, United States
California Pacific Medical Center, San Francisco, California, United States
Kaiser Permanente Medical Center, Vallejo, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Norwalk Hospital/WCHN, Norwalk, Connecticut, United States
Florida State University College of Medicine, Sarasota, Florida, United States
Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center, Augusta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Sudarshan Sharma LTD, Hinsdale, Illinois, United States
Community Health Network, Inc., Indianapolis, Indiana, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Women's Cancer Care, Covington, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
WK Physician Network Clinical Research, Shreveport, Louisiana, United States
Holy Cross Hospital, Silver Spring, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Mercy Women's Oncology, Springfield, Missouri, United States
Center of Hope, Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
MD Anderson Cancer Center - Cooper Health, Camden, New Jersey, United States
Overlook Medical Center, Summit, New Jersey, United States
The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center, Albuquerque, New Mexico, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester), New York, New York, United States
Levine Cancer Institute - Carolinas Medical Center, Charlotte, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Fairview Hospital, Moll Pavilion Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
OSU Wexner Medical Center, Columbus, Ohio, United States
Hillcrest Hospital, Mayfield, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Magee - Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Women & Infants of Rhode Island, Providence, Rhode Island, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Texas Oncology-Austin Central, Austin, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology - Fort Worth, Fort Worth, Texas, United States
Texas Oncology - The Woodlands, Gynecologic Oncology, The Woodlands, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
Kadlec Clinic Hematology & Oncology, Kennewick, Washington, United States
Froedtert and Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
AZ Groeninge - Oncology Centre, Kortrijk, , Belgium
Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg, Leuven, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
University Clinical Center of Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Research Institute - Odette Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital de la CitedelaSante, Laval, Quebec, Canada
Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada
McGill University Health Centre - Glen Site, Montréal, Quebec, Canada
Porodnicka A Gynekologicka Klinika, Hradec Králové, , Czechia
University Hospital Ostrava, Ostrava Poruba, , Czechia
Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin, Zlín, , Czechia
Institut de Cancerologie de L'Ouest - site Paul Papin, Angers, , France
CHRU Jean Minjoz, Besançon, , France
Institut Bergonie, Bordeaux, , France
Cochin Hospital, Paris, , France
Hôpital Croix St-Simon, Paris, , France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, , France
Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol, Plérin, , France
Centre Eugene Marquis, Rennes, , France
Institut Curie-Hopital Rene Huguenin, Saint-Cloud, , France
Institut Claudius Regaud, Toulouse, , France
Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy, , France
Gustave Roussy Institution, Villejuif, , France
Bon Secours Hospital, Cork, , Ireland
Mater Private Hospital and Mater Misericordiae University Hospital, Dublin, , Ireland
Istituto Europeo di Oncologia, Milano, MI, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, , Italy
Azienda Sanitaria Locale (ASL), Brindisi, , Italy
Azienda Unita Sanitaria Locale di Ravenna, Faenza, , Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica, Meldola (FC), , Italy
Ospedale San Raffaele, Milan, , Italy
Fondazione IRCCS National Cancer Institute, Milan, , Italy
Istituto Nazionale Tumori- G. Pascale, Naples, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
LLC "VitaMed", Moscow, , Russian Federation
State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary", Novosibirsk, , Russian Federation
Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary", Omsk, , Russian Federation
State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary", Saint Petersburg, , Russian Federation
Oncology and Radiology Institute Serbia, Belgrade, , Serbia
Clinical Centre Nis, Oncology Clinic, Niš, , Serbia
Oncology Institute Vojvodina, Sremska Kamenica, , Serbia
ICO Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Onkologikoa, Donostia San Sebastian, Gipuzkoa, Spain
Hospital Teresa Herrera (CHUACoruña), A Coruña, , Spain
IOR - Hospital Quiron Dexeus, Barcelona, , Spain
Hospital Vall D'Hebron, Barcelona, , Spain
Institut Català d'Oncologia - Unitad de Investigación Clínica, Barcelona, , Spain
Hospital Reina Sofia, Córdoba, , Spain
Complejo Hospitalario Granada, Granada, , Spain
Hospital Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center - Madrid, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Servicio de Oncología Médica Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga, Malaga, , Spain
Hospital Son Llatzer (HSLL), Palma de Mallorca, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Kantonsspital Winterthur, Medizinische Onkologie, Winterthur, Zurich, Switzerland
Kantonsspital, Winterthur, Zurich, Switzerland
Hopitaux Universitaires de Geneve, Geneve, , Switzerland
UCL Cancer Institute, London, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, England, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital, Preston, England, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH), Sutton, England, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW, Wolverhampton, England, United Kingdom
Peterborough City Hospital, Peterborough, Great Britain, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University, Stoke-on-Trent, Staffordshire, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre, Coventry, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Contact Details
Name: CMO ImmunoGen
Affiliation: ImmunoGen, Inc.
Role: STUDY_DIRECTOR
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