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New drug combo aims to treat bladder cancer without chemo

NCT ID NCT05645692

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This Phase 2 trial tests two new immunotherapy drugs, tobemstomig alone or with tiragolumab, against the standard drug atezolizumab. It includes 204 people with advanced bladder cancer who cannot have platinum chemotherapy. The main goal is to check safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tobemstomig (alone or with tiragolumab) compared to atezolizumab
What this could lead to
If successful, this could offer a new immunotherapy option for people with advanced bladder cancer who cannot take standard chemotherapy.
What could go wrong
This is an early Phase 2 trial with only 204 participants, so results may not confirm benefit. Immunotherapies can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

204 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urothelial cancer

Contacts and locations

Locations

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

    Santo André, São Paulo, 09060-650, Brazil

  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

    Bari, Apulia, 70124, Italy

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Adana Baskent University Medical Faculty

    Adana, 01220, Turkey (Türkiye)

  • Alexandras General Hospital of Athens

    Athens, 115 28, Greece

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Attikon University General Hospital

    Chaïdári, 124 62, Greece

  • Azienda Ospedaliera S. Maria - Terni

    Terni, Umbria, 05100, Italy

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Barts and the London NHS Trust

    London, E1 2ES, United Kingdom

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Centre Leon Berard

    Lyon, 69373, France

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722, Turkey (Türkiye)

  • Gustave Roussy

    Villejuif, 94800, France

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903, Brazil

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Evangelico De Curitiba

    Curitiba, Paraná, 80440-220, Brazil

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Amor Amazônia

    Porto Velho, Rondônia, 76834-899, Brazil

  • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • ICON Cancer Care Adelaide

    Kurralta Park, South Australia, 5037, Australia

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

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

    Meldola, Emilia-Romagna, 47014, Italy

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Istituto Nazionale Tumori Irccs Fondazione G. Pascale

    Naples, Campania, 80131, Italy

  • Izmir Medical Point Hospital

    Izmir, 35101, Turkey (Türkiye)

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120, Germany

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112, Australia

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2113, Australia

  • Martini-Klinik am UKE GmbH

    Hamburg, 20246, Germany

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Pratia Poznan

    Późna, 60-192, Poland

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT, United Kingdom

  • Royal Preston Hosptial

    Preston, PR2 9HT, United Kingdom

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University

    Seoul, 03722, South Korea

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060, China

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

    Warsaw, 04-073, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501, Poland

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581, Poland

  • Theageneio Hospital

    Thessaloniki, 54007, Greece

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

    Edirne, 22030, Turkey (Türkiye)

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

    Barcelona, 08035, Spain

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

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