Spots Global Cancer Trial Database for Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
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Trial Identification
Brief Title: Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
Official Title: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO)
Study ID: NCT05041257
Interventions
Study Description
Brief Summary: PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
Detailed Description: Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients will have had at least 2 prior lines of therapy. These will include at least 2 lines of platinum-containing therapy or 1 line with a documented platinum allergy. FRα positivity will be defined by the Ventana FOLR1 (FOLR1- 2.1) CDx assay (Ventana FOLR1 Assay)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center, Birmingham, Alabama, United States
Alaska Women's Cancer Care/Providence Alaska Medical Center, Anchorage, Alaska, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit, Los Angeles, California, United States
University of Colorado School of Medicine, Aurora, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
University of Miami, Miami, Florida, United States
Florida Cancer Specialist North Division, Saint Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialist East Division, West Palm Beach, Florida, United States
Women's Cancer Center, Covington, Louisiana, United States
Maine Medical Partners - Women's Health, Scarborough, Maine, United States
Tufts Medical Center, Boston, Massachusetts, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
Duke University, Durham, North Carolina, United States
Cleveland Clinic Fairview Hospital-Moll Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Zangmeister Cancer Center / Sarah Cannon Research Institute, Columbus, Ohio, United States
Hillcrest Hospital: North Campus, Mayfield Heights, Ohio, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Northwest Cancer Specialist, P.C., Portland, Oregon, United States
Women & Infants Hospital of Rhode Island Oncology Research, Providence, Rhode Island, United States
Tennessee Oncology / Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-South Austin, Austin, Texas, United States
Texas Oncology - Dallas Presbyterian, Dallas, Texas, United States
Texas Oncology, The Woodlands, Texas, United States
Virginia Cancer Specialists, PC, Gainesville, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Kadlec Clinic Hematology & Oncology, Kennewick, Washington, United States
Newcastle Private Hospital, New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre, Toorak Gardens, South Australia, Australia
Monash Health, Clayton, Victoria, Australia
Cabrini Hospital Malvern, Malvern, Victoria, Australia
St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU UCL, Namur, , Belgium
Princess Margaret Cancer Centre - University Health Network, Toronto, Ontario, Canada
McGill University Health Center, Montréal, Quebec, Canada
Ciussse-Chus, Sherbrooke, Quebec, Canada
Centre Oscar Lambret, Lille, , France
Centre Léon Bérard, Lyon, , France
Institut Poali Calmette, Marseille, , France
Groupe Hospitalier Diaconesse, Croix Saint-Simon, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Centre CARIO - HPCA, Plerin, , France
ICO Centre Rene Gauducheau, Saint-Herblain Cedex, , France
Institut de Cancerologie Strabsourg Europe Unité de recherche clinique, Strasbourg, , France
Bon Secours Hospital, Cork, , Ireland
St James's Hospital, Dublin, , Ireland
Beaumont Hospital, Dublin, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Azienda Ospedaliero-Universitaria-IRCCS, Bologna, , Italy
Osperdale Cannizzaro di Catania, Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IRCCS - Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori Napoli, Napoli, , Italy
Azienda Unita Sanitaria Locale di Ravenna, Ravenna, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, , Italy
ClÃ-nica Universidad de Navarra (CUN), Pamplona, Madrid, Spain
Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta), Badalona, , Spain
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Institut Català d' Oncologia L' Hospitalet, Barcelona, , Spain
Complejo Hospitalario Provincial de Castellón, Castelló, , Spain
Hospital Reina Sofia, Cordoba, , Spain
Hospital Universitario HU de Jaen, Jaen, , Spain
Hospital MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital de San Chinarro-Clara Campal, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Virgen del Rocío, Sevilla, , Spain
Hospital Clinico, Valencia, , Spain
Contact Details
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