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
NCT ID: NCT05645692
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
204 participants
INTERVENTIONAL
2023-04-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
Atezolizumab
Participants will receive 1200 mg IV atezolizumab Q3W.
Arm B
Participants will receive IV tobemstomig Q3W.
Tobemstomig
Participants will receive 600 mg IV tobemstomig Q3W.
Arm C
Participants will receive IV tobemstomig + IV tiragolumab Q3W.
Tobemstomig
Participants will receive 600 mg IV tobemstomig Q3W.
Tiragolumab
Participants will receive 600 mg IV tiragolumab Q3W.
Interventions
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Atezolizumab
Participants will receive 1200 mg IV atezolizumab Q3W.
Tobemstomig
Participants will receive 600 mg IV tobemstomig Q3W.
Tiragolumab
Participants will receive 600 mg IV tiragolumab Q3W.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Participants with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Participants with other variant histologies or pure variant histologies are not eligible for inclusion in this study
* Ineligible ("unfit") to receive platinum-based chemotherapy
* No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)
* Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)
* Availability of a representative leftover tumor specimen that is suitable for determination of PD-L1 status as assessed by a central laboratory
* Adequate hematologic and end organ function
* Negative for hepatitis B and hepatitis C virus (HCV)
* Adequate cardiovascular function
Exclusion Criteria
* GFR \<15 mL/min/1.73 m2
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis (TB) or acute Epstein-Barr virus (EBV)
* Significant cardiovascular/cerebrovascular disease within 3 months prior to initiation of study treatment
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* History of another primary malignancy other than urothelial carcinoma within 2 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death
* Severe infection within 4 weeks prior to initiation of study treatment
* Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease \[COPD\] exacerbation), or who are receiving oral antibiotics to treat a urinary tract infection are eligible for the study
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of tobemstomig, or 90 days after the final dose of tiragolumab
* Current treatment with anti-viral therapy for HBV
* Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
* Treatment with investigational therapy within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting agents
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-LaRoche
Locations
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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
Napoli, 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)
Padua, 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
Countries
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Other Identifiers
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BO44157
Identifier Type: -
Identifier Source: org_study_id
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