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Brief Title: A Trial of Tisotumab Vedotin in Cervical Cancer
Official Title: A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
Study ID: NCT03438396
Brief Summary: A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
Detailed Description: The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama, Birmingham, Alabama, United States
Arizona Oncology Associate - Biltmore Cancer Center, Phoenix, Arizona, United States
UCLA Dept. of OBGYN, Los Angeles, California, United States
Southern Baptist Hospital of Florida, Inc, Jacksonville, Florida, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
University of Gynecologic Oncology, Atlanta, Georgia, United States
Community Hospital East, Indianapolis, Indiana, United States
Louisville Oncology, Louisville, Kentucky, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
MD Anderson Cancer Center at Cooper University Hospital, Camden, New Jersey, United States
University of New Mexico Comprehensive Cancer Center (UNMCCC), Albuquerque, New Mexico, United States
University of Cincinnati, Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center, Hilliard, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Willow Grove, Pennsylvania, United States
Bon Secours Saint Francis Cancer Center, Greenville, South Carolina, United States
UT Health McGovern Medical School, Houston, Texas, United States
Froedtert & Medical College Clinics, Milwaukee, Wisconsin, United States
AZ Sint-Jan Brugge-Oostende av, Brugge, , Belgium
Cliniques universitaires Saint-Luc, Brussels, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Algemeen Ziekenhuis Maria MiddelaresMedical Oncology - IKG, Gent, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UZLeuvenGynaecologische oncologie, Leuven, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
CHU de LIEGE/ Oncologie Médicale, domaine universitaire du Sart Tilman, Liege, , Belgium
CHC SAINT Montlegia, Liège, , Belgium
CHU UCL Namur site de Sainte Elisabeth, Namur, , Belgium
Fakultni Nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc Onkologic, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze, Prague, , Czechia
Nemocnice Na Bulovce, Gynekologicko-porodnicka kl, Prague, , Czechia
Aalborg Universitetshospital, Aalborg, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Kliniken Essen-Mitte, Duesseldorf, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Klinikum der Universität München, Münich, , Germany
Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, , Italy
Irst Irccs, Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Naples, , Italy
Policlinico Universitario Agostino Gemelli, UOC Patologia Ostetrica e Ginecologica, Rome, , Italy
Hospital Teresa Herrera-CHUAC, A Coruna, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Duran I Reynals ICO Hospitalet, Hospitalet de Llobregat, , Spain
Clínica Universidad de Navarra (Sede Madrid), Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Edificio dotacional de Oncología, Madrid, , Spain
Fundacion Hospital Son Llatzer, Palma de Mallorca, , Spain
Skåne University Hospital, Lund, , Sweden