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Clinical Trials in the USA / NCT05645692
Active, not recruiting Phase 2

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

NCT05645692 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2023-04-13
Last updated
2026-07-28

Condition(s) studied

Urothelial Cancer

Investigational drug(s) / intervention(s)

AtezolizumabTobemstomigTiragolumab

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Cleveland Clinic Cleveland Ohio
MD Anderson Cancer Center Houston Texas
Macquarie University Hospital Macquarie Park New South Wales
Lyell McEwin Hospital Adelaide South Australia
ICON Cancer Care Adelaide Kurralta Park South Australia
Hospital Universitario Evangelico De Curitiba Curitiba Paraná
Hospital das Clinicas - UFRGS Porto Alegre Rio Grande do Sul
Hospital de Amor Amazônia Porto Velho Rondônia
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia Santo André São Paulo
Hospital Alemao Oswaldo Cruz São Paulo São Paulo
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
Istituto Nazionale Tumori Irccs Fondazione G. Pascale Naples Campania
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna Emilia-Romagna
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola Meldola Emilia-Romagna
Policlinico Universitario "Agostino Gemelli" Rome Lazio
Irccs Ospedale San Raffaele Milan Lombardy
Azienda Ospedaliera S. Maria - Terni Terni Umbria
IRCCS Istituto Oncologico Veneto (IOV) Padova Veneto
Health Pharma Professional Research Mexico City Mexico CITY (federal District)
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

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Hoffmann-La Roche trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05645692 on ClinicalTrials.gov ↗ ← All trials in the USA