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ACTIVE NOT RECRUITING
NCT05645692
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the safety 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2023-04-13

Completion Date

2026-12-31

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Participants will receive 1200 mg IV atezolizumab Q3W.

DRUG

Tobemstomig

Participants will receive 600 mg IV tobemstomig Q3W.

DRUG

Tiragolumab

Participants will receive 600 mg IV tiragolumab Q3W.

Locations (56)

Cleveland Clinic

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, 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, Paraná, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor Amazônia

Porto Velho, Rondônia, Brazil

*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Beijing Cancer Hospital

Beijing, China

West China Hospital - Sichuan University

Chengdu, China

Sun yat-sen University Cancer Center

Guangzhou, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Aarhus Universitetshospital

Aarhus N, Denmark

Herlev Hospital

Herlev, Denmark

Centre Leon Berard

Lyon, France

Gustave Roussy

Villejuif, France

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

Halle, Germany

Martini-Klinik am UKE GmbH

Hamburg, Germany

Alexandras General Hospital of Athens

Athens, Greece

Attikon University General Hospital

Chaïdári, Greece

Theageneio Hospital

Thessaloniki, Greece

A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

Bari, Apulia, Italy

Istituto Nazionale Tumori Irccs Fondazione G. Pascale

Naples, Campania, Italy

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

Policlinico Universitario "Agostino Gemelli"

Rome, Lazio, Italy

Irccs Ospedale San Raffaele

Milan, Lombardy, Italy

Azienda Ospedaliera S. Maria - Terni

Terni, Umbria, Italy

IRCCS Istituto Oncologico Veneto (IOV)

Padova, Veneto, Italy

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Pratia Poznan

Późna, Poland

Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

Warsaw, Poland

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

Madrid, Spain

Adana Baskent University Medical Faculty

Adana, Turkey (Türkiye)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, Turkey (Türkiye)

Izmir Medical Point Hospital

Izmir, Turkey (Türkiye)

Goztepe Prof.Dr. Suleyman Yalcin City Hospital

Kadiköy, Turkey (Türkiye)

Barts and the London NHS Trust

London, United Kingdom

Royal Preston Hosptial

Preston, United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom