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Brief Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
Official Title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy
Study ID: NCT04246489
Brief Summary: The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Highlands Oncology Group, Fayetteville, Arkansas, United States
University of Arkansas Medical Sciences, Little Rock, Arkansas, United States
Stanford University Hospital and Clinics - Stanford Cancer Center, Stanford, California, United States
The Stamford Hospital, Stamford, Connecticut, United States
Karmanos Cancer Institute, Farmington Hills, Michigan, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
UC Health Clinical Trials Office, Cincinnati, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
The West Clinic, Germantown, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Sanatorio El Parque, Salta, , Argentina
Centro Medico San Roque S.R.L., San Miguel de Tucuman, , Argentina
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, , Australia
Linear Clinical Research Limited, Nedlands, , Australia
Calvary Mater Newcastle, Waratah, , Australia
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Universitair Ziekenhuis Gent - Pneumology, Gent, , Belgium
AZ Groeninge - Campus Kennedylaan - account 2, Kortrijk, , Belgium
CHU de Liège - PARENT, Liège, , Belgium
CHU Sart Tilman, Liège, , Belgium
UZ Leuven, Pellenberg, , Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk, , Belgium
HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer, Porto Alegre, , Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda., São Paulo, , Brazil
IBCC - Instituto Brasileiro de Controle do Câncer, São Paulo, , Brazil
Chongqing Cancer Hospital, Chongqing, , China
Sun Yat-sen University, Cancer Center, Guangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Anhui Provincial Hospital, Hefei, , China
Shanghai Cancer Hospital, Fudan University, Shanghai, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
Institut Bergonié, Bordeaux cedex, , France
Centre Oscar lambret - Service d'Oncologie medicale, Lille cedex, , France
Centre Léon Bérard, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hôpital Cochin - Hematologie et Oncologie Médicale, Paris, , France
Centre Hospitalier Lyon Sud - service d'oncologie medicale, Pierre Benite cedex, , France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, Plérin, , France
Institut Jean Godinot - Service d'hématologie et Oncologie Médicale, Reims cedex, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale, Strasbourg, , France
Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly, Budapest, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia, Nyiregyhaza, , Hungary
National Cancer Center Hospital - Dept of Mammary Gland/Oncology, Chuo-ku, , Japan
NHO Kyushu Cancer Center - Dept of Gynecology, Fukuoka-shi, , Japan
Saitama Medical University International Medical Center - Dept of Gynecology/Oncology, Hidaka-shi, , Japan
Cancer Institute Hospital of JFCR - Dept of Gynecology, Koto-ku, , Japan
Kurume University Hospital - Dept of Gynecology, Kurume-shi, , Japan
Jikei University Hospital - Dept of Gynecology, Minato-ku, , Japan
University Hospital, University of the Ryukyus - Dept of Obstetrics/Gynecology, Nakagami-gun, , Japan
Osaka International Cancer Institute - Dept of Gynecology, Osaka-shi, , Japan
NHO Hokkaido Cancer Center - Dept of Gynecology, Sapporo-shi, , Japan
Kanagawa Cancer Center - Dept of Gynecology, Yokohama-shi, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
BHI of Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
LLC "ClinicaUZI4D", Pyatigorsk, , Russian Federation
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, , Spain
ICO Girona - Hospital Doctor Josep Trueta - Servicio de Oncologia Medica, Girona, , Spain
Clinica Universidad de Navarra (MAD) - Oncology Service, Madrid, , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia, , Spain
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR