Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of RO7247669, Tiragolumab, and Atezolizumab for Patients with Untreated Advanced Urothelial Cancer Ineligible for Platinum Chemotherapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study involves three different treatments: RO7247669, tiragolumab, and atezolizumab. RO7247669 is also known by the code name TOBEMSTOMIG. These treatments are types of immunotherapy, which help the body's immune system fight cancer.

The purpose of the study is to evaluate how effective these treatments are in patients who have not received any previous treatment for their advanced or metastatic urothelial cancer and are not eligible for chemotherapy that contains platinum. The study will compare the effects of RO7247669 alone, RO7247669 combined with tiragolumab, and atezolizumab alone. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment. The study will look at how many participants experience a reduction in their cancer, how long it takes for the cancer to progress, and overall survival rates. The study will also track any side effects that participants may experience. This research aims to find the most effective treatment option for patients with this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including performance status and medical history related to urothelial cancer.

    A representative tumor specimen is required for analysis to determine specific markers.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

  3. Step 3

    Treatment administration

    Participants receive treatment through intravenous infusion. The specific treatment depends on the group assigned during randomization.

    The treatments include atezolizumab, RO7247669, and tiragolumab, either alone or in combination. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure the size and progression of the cancer.

    Participants are also monitored for any side effects or adverse reactions to the treatment.

  5. Step 5

    Follow-up evaluations

    Follow-up evaluations are scheduled to continue monitoring the participant's health and the effectiveness of the treatment.

    These evaluations help determine the overall response rate and progression-free survival.

  6. Step 6

    Completion of study participation

    Upon completion of the study, participants may undergo final assessments to gather data on long-term outcomes and any lasting effects of the treatment.

Who can join the trial?

9 criteria

  • The patient must have **previously untreated** locally advanced or metastatic urothelial cancer. This means the cancer has not been treated before and has spread to nearby areas or other parts of the body.
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 2 or less. This is a scale that measures how well a patient can perform daily activities, with lower numbers indicating better ability.
  • The patient must have a type of cancer called **transitional cell carcinoma (TCC)** of the urothelium, which is the lining of the bladder and other parts of the urinary tract. The cancer must have a urothelial component, even if it has other types of cells.
  • The patient must be considered **ineligible** or "unfit" to receive platinum-based chemotherapy. This could be due to certain health conditions or the patient's ability to handle chemotherapy.
  • The patient must not have had any **prior chemotherapy** for inoperable locally advanced, metastatic, or recurrent urothelial carcinoma.
  • The patient must have **measurable disease**, meaning there is at least one tumor that can be measured to see if it changes in size during the study.
  • The patient must provide a **tumor specimen** that can be used to check for certain markers, like PD-L1 status, which helps in understanding the cancer better and planning treatment.
  • The study is open to both **male and female** patients.
  • The study includes patients who are considered part of a **vulnerable population**, meaning they might need extra protection or care during the study.

Who cannot join the trial?

9 criteria

  • Patients who have already received treatment for their urothelial cancer cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned, cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients with certain heart conditions that are not well controlled cannot participate.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • RO7247669

    is an investigational medication being studied for its potential to treat urothelial cancer. It is being tested to see how well it works on its own and in combination with another medication. Researchers are looking at how effective it is in shrinking tumors or stopping them from growing.

  • Tiragolumab

    is another investigational medication used in this study. It is being combined with RO7247669 to see if the combination is more effective than using RO7247669 alone. The goal is to determine if this combination can improve the treatment outcomes for patients with urothelial cancer.

  • Atezolizumab

    is an approved medication that is used as a comparison in this study. It is a type of immunotherapy that helps the immune system attack cancer cells. The study aims to compare the effectiveness of RO7247669, both alone and in combination with tiragolumab, against atezolizumab in treating urothelial cancer.

What is already known about the treatment

  • RO7247669

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating previously untreated locally advanced or metastatic urothelial cancer. It is being evaluated both alone and in combination with tiragolumab. The main therapeutic indication is for patients who are ineligible for platinum-containing chemotherapy. RO7247669 works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. It is classified as an immunotherapy agent.

  • Tiragolumab

    This medication is also administered intravenously and is under investigation in clinical trials for its potential to treat previously untreated locally advanced or metastatic urothelial cancer. It is being tested in combination with RO7247669. The primary therapeutic use is for patients who cannot receive platinum-based chemotherapy. Tiragolumab functions by blocking certain immune checkpoints, thereby enhancing the body's immune response against cancer cells. It belongs to the class of immune checkpoint inhibitors.

  • Atezolizumab

    Administered intravenously, atezolizumab is an established medication used in the treatment of various cancers, including urothelial cancer. It is being compared to RO7247669 and its combination with tiragolumab in clinical trials. The main therapeutic indication is for patients with advanced urothelial cancer who are not suitable for platinum-based chemotherapy. Atezolizumab works by inhibiting the PD-L1 protein, which helps the immune system to detect and destroy cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that typically begins in the cells lining the bladder, but it can also occur in other parts of the urinary tract. It is characterized by the abnormal growth of cells in the urothelium, which is the tissue lining the bladder and other parts of the urinary system. The disease can be classified as either non-invasive, where the cancer cells are confined to the inner layer of the bladder, or invasive, where the cancer has spread into the muscle layer or beyond. In its advanced stages, the cancer may spread to nearby tissues or distant organs, a process known as metastasis. Symptoms often include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining localized while others become more aggressive and spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504027-78-00Protocol codeBO44157Estimated enrolment244 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.