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Brief Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
Official Title: A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
Study ID: NCT04697628
Brief Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
University of California Irvine Medical Center, Irvine, California, United States
Olive View - UCLA Medical Center, Sylmar, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Broward Health Medical Center, Fort Lauderdale, Florida, United States
Augusta University, Augusta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Gynecological Cancer Institute of Chicago, LLC, Oak Lawn, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Willis-Knighton Physician Network/Gynecologic Oncology Associates, Shreveport, Louisiana, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
Minnesota Oncology Hematology P.A., Minneapolis, Minnesota, United States
St. Dominic - Jackson Memorial Hospital, Jackson, Mississippi, United States
Washington University in St Louis, Saint Louis, Missouri, United States
Weill Cornell Medicine, Brooklyn, New York, United States
Weill Cornell Medicine, Flushing, New York, United States
New York University (NYU) Cancer Institute, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
Ohio State University Clinical Trials Management Office, Hilliard, Ohio, United States
Kettering Health, Kettering, Ohio, United States
Cleveland Clinic Hillcrest Hospital, Mayfield Heights, Ohio, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Texas Oncology - Austin Central, Austin, Texas, United States
Texas Oncology - Fort Worth 12th Avenue, Fort Worth, Texas, United States
Texas Oncology - The Woodlands, The Woodlands, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Carbone Cancer Center / University of Wisconsin, Madison, Wisconsin, United States
Instituto Oncologico de Cordoba, Córdoba, Other, Argentina
Fundacion Cenit, Caba, , Argentina
Instituto Alexander Fleming, Caba, , Argentina
Sanatorio de la Mujer, Rosario, , Argentina
LKH- Universitat Klinikum Graz, Graz, Other, Austria
AKH - Medizinische Universitat Wien, Vienna, Other, Austria
Institut Jules Bordet, Anderlecht, Other, Belgium
ZNA Middelheim, Antwerpen, Other, Belgium
Cliniques Universitaires Saint Luc, Brussels, Other, Belgium
Universitair Ziekenhuis Gent, Gent, Other, Belgium
UZ Leuven campus Gasthuisberg, Leuven, Other, Belgium
CHU de Liege, Liege, Other, Belgium
CHU UCL Namur-Site de Saint Elisabeth, Namur, Other, Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Erasto Gaertner Hospital, Curitiba, Other, Brazil
Hospital de Caridade de Ijui, Ijui, Other, Brazil
Hospital Mãe de Deus, Porto Alegre, Other, Brazil
Centro de Pesquisa em Oncologia - HSL-PUCRS, Porto Alegre, Other, Brazil
Brazilian National Cancer Institute, Rio de Janeiro, Other, Brazil
Hospital Beneficencia Portuguesa, Sao Paulo, Other, Brazil
Fundacao Antonio Prudente (AC Camargo Cancer Center), Sao Paulo, Other, Brazil
Instituto Brasileiro de Controle do Cancer, Formosa, , Brazil
University of Alberta / Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Other, China
Beijing Obstetrics and Gynecology Hospital, Beijing, Other, China
Peking University People's Hospital, Beijing, Other, China
Jilin University - First Affiliated Hospital - Cancer Center, Changchun, Other, China
The Third Xiangya Hospital of Central South University, Changsha, Other, China
Hunan Cancer Hospital, Changsha, Other, China
Sichuan Cancer Hospital, Chengdu, Other, China
Chongqing Cancer Hospital, Chongqing, Other, China
The Second Hospital of Dalian Medical University, Dalian, Other, China
Sun Yat-sen University Cancer Center, Guangzhou City, Other, China
Zhejiang Cancer Hospital, Hangzhou City, Other, China
Shandong Cancer Hospital, Jinan, Other, China
Shanghai First People's Hospital, Shanghai, Other, China
Liaoning Cancer Hospital and Institute, Shenyang, Other, China
The Second Hospital of Hebei Medical University, Shijiazhuang, Other, China
The Second Hospital of Shanxi Medical University, Taiyuan, Other, China
Shanxi Province Cancer Hospital, Taiyuan, Other, China
The Affiliated Cancer Hospital of XinJiang Medical University, Urumqi, Other, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Other, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan City, Other, China
Hubei Cancer Hospital, Wuhan, Other, China
Shaanxi Provincial People's Hospital, Xi'an, Other, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Other, China
The Second People's Hospital of Yibin, Yibin, Other, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, , China
Fakultni nemocnice Brno, Brno-stred-Veveri, Other, Czechia
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika, Olomouc, Other, Czechia
General University Hospital Prague, Praha 2, Other, Czechia
Hospital Na Bulovce, Praha 8-Liben, Other, Czechia
Rigshospitalet, Kobenhavn, Other, Denmark
University of Turku, Turku, Other, Finland
Kuopio University Hospital, Kuopio, , Finland
Tampere University Hospital, Tampere, , Finland
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz, Besancon Cedex, Other, France
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie, Bordeaux, Other, France
Centre de Lutte contre le Cancer - Francois Baclesse, Caen Cedex 5, Other, France
CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie, Cotes d'Armor, Other, France
Institute Cancer De Lorraine (ICL) - Alexis Vautrin, Moselle, Other, France
Hopital Prive du Confluent, Nantes Cedex 2, Other, France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon), Paris, Other, France
Institut de cancerologie Strasbourg Europe, Strasbourg, Other, France
Institut Claudius Regaud IUCT-O, Toulouse Cedex 9, Other, France
Institut Gustave Roussy, Villejuif Cedex, Other, France
Kliniken Essen-Mitte, Essen, Other, Germany
Universitaetsklinikum Essen, Essen, Other, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE), Hamburg, Other, Germany
University Hospital LMU Munich, Munchen, Other, Germany
National Institute of Oncology Hungary, Budapest, Pest, Other, Hungary
Medical and Health Science Centre Debrecen Institution of Internal Medicine, Debrecen, Hajdú-Bihar, Other, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemet, Other, Hungary
University Hospital Waterford, Waterford, Other, Ireland
Azienda Ospedaliera per l'Emergenza, Catania, Other, Italy
Ospedale San Raffaele, Milano, Other, Italy
Fondazione Policlinico Universitario Agostino, Roma, Other, Italy
Hospital San Bortolo, Vicenza, Other, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l, Meldola, , Italy
National Cancer Center Hospital, Chuo-ku, Other, Japan
Kurume University Hospital, Fukuoka, Other, Japan
Gunma University Hospital, Gunma, Other, Japan
Saitama Cancer Center, Hidaka-City, Other, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Hiroshima, Other, Japan
Kagoshima University Hospital, Kagoshima City, Other, Japan
Kagoshima City Hospital, Kagoshima-City, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
The Jikei University Kashiwa Hospital, Kashiwashi, Other, Japan
Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Other, Japan
NHO Shikoku Cancer Center, Matsuyama, Other, Japan
Aichi Cancer Center, Nagoya-shi, Other, Japan
University of the Ryukyus Hospital, Nakagami-gun, Other, Japan
Okayama University Hospital, Okayama, Other, Japan
Kindai University Hospital, Osakasayama, Other, Japan
Osaka International Cancer Institute, Osaka, Other, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Other, Japan
Hokkaido University Hospital, Sapporo-shi, Other, Japan
Iwate Medical University Hospital, Shiwa-gun, Other, Japan
Shizuoka Cancer Center, Sunto-Gun, Other, Japan
Jikei University Hospital, Tokyo, Other, Japan
The Cancer Institute Hospital of JFCR, Tokyo, Other, Japan
Keio University Hospital, Tokyo, Other, Japan
Yokohama City University Hospital, Yokohama, Other, Japan
Kanagawa Cancer Center, Yokohama, Other, Japan
Hyogo Cancer Center, Akashi, , Japan
Ehime University Hospital, Ehime, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Keimyung University Dongsan Medical Center, Daegu, Other, Korea, Republic of
National Cancer Center, Goyang-si, Other, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Other, Korea, Republic of
CHA Bundang Medical Center, Seongnam, Other, Korea, Republic of
Korea Cancer Center Hospital, Seoul, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Soon Chun Hyang University Hospital Seoul, Seoul, Other, Korea, Republic of
Asan Medical Center, Seoul, Other, Korea, Republic of
Samsung Medical Center, Seoul, Other, Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, Other, Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Inje University Busan-Paik Hospital, Busan, , Korea, Republic of
Sungkyunkwan University of Medicine - Samsung Changwon Hospital, Changwon, Kyungsangnam-do, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Oncologico Potosino, San Luis Potosi, Other, Mexico
Amsterdam UMC, Locatie AMC, Amsterdam, Other, Netherlands
Maastricht University Medical Center, Maastricht, Other, Netherlands
Radboud University Medical Center, Nijmegen, Other, Netherlands
Erasmus Medisch Centrum Daniel Den Hoed, Rotterdam, Other, Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, Other, Netherlands
Oslo University Hospital, Radiumhospitalet, Olso, Other, Norway
Trondheim University Hospital, Trondheim, Trondheim, , Norway
Hospital Maria Auxiliadora, Lima, , Peru
Białostockie Centrum Onkologii, Białystok, Other, Poland
National University Cancer Institute, Singapore, Singapore, Other, Singapore
National Cancer Centre Singapore, Singapore, Other, Singapore
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Hospital Clinic de Barcelona, Barcelona, Other, Spain
Hospital Universitario Reina Sofia, Cordoba, Other, Spain
Clinica Universidad de Navarra, Madrid, Other, Spain
Hospital Universitario 12 de Octubre, Madrid, Other, Spain
Hospital Universitario La Paz, Madrid, Other, Spain
Clinica Universidad de Navarra, Pamplona, Other, Spain
Hospital Clinico Universitario de Valencia, Valencia, Other, Spain
Linkoping University Hospital, Linköping, Other, Sweden
Skanes University Hospital - Universitetssjukhus, Lund, Other, Sweden
Uppsala University Hospital (Akademiska Sjukhuset), Uppsala, Other, Sweden
Mackay Memorial Hospital, Taipei City, Other, Taiwan
Taipei Veterans General Hospital, Taipei City, Other, Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan, Other, Taiwan
Cambridge University Hospitals NHS Foundation Trust, Cambridge, Other, United Kingdom
Royal Devon and Exeter NHS Foundation Trust, Exeter, Other, United Kingdom
The Royal Marsden Hospital, London, Other, United Kingdom
The Christie NHS Foundation Trust, Manchester, Other, United Kingdom
The Royal Marsden Hospital (Surrey), Sutton, Other, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR