Urothelial CancerPhase 2NCT05645692
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
A Phase 2 study testing Atezolizumab, Tobemstomig and Tiragolumab in people with Urothelial Cancer, run by Hoffmann-La Roche at 56 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- Atezolizumab, Tobemstomig and Tiragolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 56 sitesin 15 countries
- Study dates
- 13 Apr 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate hematologic and end organ function
- Negative for hepatitis B and hepatitis C virus (HCV)
- Adequate cardiovascular function
Who cannot join
- 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
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- 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
Trial locations and contacts
56 sites in 15 countries.
56 sites in 15 countries
Italy8 sites
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, 70124
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
Istituto Nazionale Tumori Irccs Fondazione G. Pascale
Naples, Campania, 80131
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, 35128
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, 00168
Azienda Ospedaliera S. Maria - Terni
Terni, Umbria, 05100
South Korea6 sites
Seoul National University Bundang Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Spain6 sites
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
Madrid, 28050
Brazil5 sites
Hospital Universitario Evangelico De Curitiba
Curitiba, Paraná, 80440-220
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital de Amor Amazônia
Porto Velho, Rondônia, 76834-899
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, São Paulo, 09060-650
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-903
Turkey (Türkiye)5 sites
Adana Baskent University Medical Faculty
Adana, 01220
Ankara City Hospital
Ankara, 06800
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Izmir Medical Point Hospital
Izmir, 35101
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, 34722
China4 sites
Beijing Cancer Hospital
Beijing, 100142
West China Hospital - Sichuan University
Chengdu, 610047
Sun yat-sen University Cancer Center
Guangzhou, 510060
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Poland4 sites
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581
Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Pratia Poznan
Późna, 60-192
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warsaw, 04-073
Australia3 sites
Lyell McEwin Hospital
Adelaide, South Australia, 5112
ICON Cancer Care Adelaide
Kurralta Park, South Australia, 5037
Macquarie University Hospital
Macquarie Park, New South Wales, 2113
Greece3 sites
Alexandras General Hospital of Athens
Athens, 115 28
Attikon University General Hospital
Chaïdári, 124 62
Theageneio Hospital
Thessaloniki, 54007
United Kingdom3 sites
Barts and the London NHS Trust
London, E1 2ES
Royal Preston Hosptial
Preston, PR2 9HT
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44106
MD Anderson Cancer Center
Houston, Texas, 77030
Denmark2 sites
Aarhus Universitetshospital
Aarhus N, 8200
Herlev Hospital
Herlev, 2730
Germany2 sites
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
Halle, 06120
Martini-Klinik am UKE GmbH
Hamburg, 20246
Mexico1 site
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100
About this study
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
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.
- Conditions
- Urothelial Cancer
- Being tested
- Atezolizumab, Tobemstomig, Tiragolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Participants will receive 1200 mg IV atezolizumab Q3W.
TobemstomigDrug
Also called RO7247669
Participants will receive 600 mg IV tobemstomig Q3W.
TiragolumabDrug
Participants will receive 600 mg IV tiragolumab Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W). Receives: Drug: Atezolizumab |
| Arm B | Experimental | Participants will receive IV tobemstomig Q3W. Receives: Drug: Tobemstomig |
| Arm C | Experimental | Participants will receive IV tobemstomig + IV tiragolumab Q3W. Receives: Drug: Tobemstomig; Drug: Tiragolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start13 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-LaRoche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645692
- Sponsor's protocol ID
- BO44157
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05645692
- Acronym / sponsor ID
- BO44157
- Conditions
- Urothelial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: AtezolizumabParticipants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W). |
| Arm B | Experimental | Drug: TobemstomigParticipants will receive IV tobemstomig Q3W. |
| Arm C | Experimental | Drug: Tobemstomig, Drug: TiragolumabParticipants will receive IV tobemstomig + IV tiragolumab Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabParticipants will receive 1200 mg IV atezolizumab Q3W. | Drug | Arm A |
| TobemstomigAlso: RO7247669Participants will receive 600 mg IV tobemstomig Q3W. | Drug | Arm B, Arm C |
| TiragolumabParticipants will receive 600 mg IV tiragolumab Q3W. | Drug | Arm C |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: Up to approximately 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-LaRoche
56 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Tobemstomig and Tiragolumab in people with Urothelial Cancer, run by Hoffmann-La Roche at 56 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Italy, South Korea, Spain, Brazil, Turkey (Türkiye) and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: Up to approximately 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.