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

Running, not enrolling · Phase 2

Conditions studied: Urothelial Cancer

In brief

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.

Key facts

Study ID: NCT05645692
Run by: Hoffmann-La Roche
People needed: 204
Starts: 2023-04-13
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
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

You may not qualify if…

Pregnancy or breastfeeding
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

Where it is running

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
Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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