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Brief Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Official Title: A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy
Study ID: NCT03833661
Brief Summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Scottsdale, Arizona, United States
UCSF Mount Zion Medical Ctr, San Francisco, California, United States
Mayo Clinic in Florida - Department of Neurology, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
MD Anderson Cancer Center - Unit, Houston, Texas, United States
Peking University Cancer Hospital, Beijing, , China
Affiliated Tumor Hospital of Harbin Medical University, Harbin, , China
Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest, Pessac Cedex, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Institut Gustave Roussy, Villejuif cedex, , France
Istituto Clinico Humanitas, Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria, Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, , Italy
Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica, Roma, , Italy
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology, Chuo-ku, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Kyorin University Hospital - Dept of Oncology, Mitaka-shi, , Japan
Kindai University Hospital - Dept of Gastroenterology, Osakasayama-shi, , Japan
Kanagawa Cancer Center, Yokohama-shi, , Japan
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, , Spain
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia, Madrid, , Spain
Chang Gung Memorial Hospital, Linkou, Linkou, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
St James's University Hospital - Dept of Oncology, Leeds, , United Kingdom
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR