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Brief Title: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer
Official Title: A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy
Study ID: NCT05645692
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Advent Health Orlando, Orlando, Florida, United States
Cleveland Clinic, Cleveland, Ohio, United States
SCRI Mark H. Zangmeister Center, Columbus, Ohio, United States
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center; Oncology, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Lyell McEwin Hospital, Adelaide, South Australia, Australia
ICON Cancer Care Adelaide, Kurralta Park, South Australia, Australia
Hospital Universitario Evangelico De Curitiba, Curitiba, PR, Brazil
Oncoclinicas Rio de Janeiro S.A., Rio de Janeiro, RJ, Brazil
Hospital de Amor Amazônia, Porto Velho, RO, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André, SP, Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, SP, Brazil
Peking University First Hospital, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
West China Hospital - Sichuan University, Chengdu City, , China
Sun yat-sen University Cancer Center; Internal Medicine of Oncology, Guangzhou, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai City, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Tianjin Cancer Hospital; urologic tumor, Tianjin City, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Aalborg Universitetshospital; Onkologisk Afdeling, Aalborg, , Denmark
Aarhus Universitetshospital; Kræftafdelingen, Aarhus N, , Denmark
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed, Odense C, , Denmark
CHRU Besançon, Besançon, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Centre Leon Berard, Lyon CEDEX 08, , France
Institut Régional du Cancer de Montpellier, Montpellier, , France
Centre Eugène Marquis, Rennes, , France
Gustave Roussy, Villejuif, , France
Universitätsklinikum Düsseldorf; Urologische Klinik, Düsseldorf, , Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie, Halle (Saale), , Germany
Martini-Klinik am UKE GmbH, Hamburg, , Germany
Universitaetsklinikum Muenster; Urology, Muenster, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
Athens Medical Center; Dept. of Oncology, Athens, , Greece
Attikon University General Hospital, Chaidari, , Greece
Theageneio Hospital, Thessaloniki, , Greece
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica, Roma, Lazio, Italy
Irccs Ospedale San Raffaele, Milano, Lombardia, Italy
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria, Bari, Puglia, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia, Terni, Umbria, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Seoul National University Bundang Hospital; Internal Medicine, Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia, Mexico City, Mexico CITY (federal District), Mexico
Instituto Nacional de Cancerologia, Mexico City, Mexico CITY (federal District), Mexico
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna, Kraków, , Poland
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37, Olsztyn, , Poland
Centrum Medyczne Pratia Poznan, Skórzewo, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o., Warszawa, , Poland
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Adana Baskent University Medical Faculty; Oncology, Adana, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Izmir Medical Point Hospital, Izmir, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Western General Hospital; Clinical Oncology, Edinburgh, , United Kingdom
Barts and the London NHS Trust, London, , United Kingdom
Royal Preston Hosptial, Preston, , United Kingdom
Lister Hospital; Oncology Dept, Stevenage, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-LaRoche
Role: STUDY_DIRECTOR