Active not recruitingPHASE2INTERVENTIONAL

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

This research study is looking at new immune-boosting medicines for people with bladder cancer that has spread (called urothelial cancer). These medicines, called immunotherapies, help your own body fight cancer. The study will compare whether taking a medicine called tobemstomig by itself, or tobemstomig with another medicine called tiragolumab, is safe and effective. These treatments will be compared to another immunotherapy called atezolizumab. This study is for people who haven't had treatment for their advanced bladder cancer yet and can't have traditional chemotherapy. The main goal is to find out if these new combinations are safe and might be a good option for patients in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

204

Start

13 Apr 2023

Estimated completion

31 Dec 2026

Urothelial Cancer

What is this study about?

This clinical trial is designed to investigate new ways to treat a specific type of cancer called urothelial cancer, which most commonly starts in the bladder but can be found elsewhere in the urinary system. In this study, we're focusing on cases where the cancer has grown into nearby tissues or spread to other parts of the body, and for which standard chemotherapy treatments aren't suitable. Doctors are always looking for better and safer treatments, particularly for patients who have limited options.

Immunotherapy is a type of treatment that uses your body's own immune system to find and destroy cancer cells. This study is testing several different immunotherapies. One of the main goals is to see how safe these new treatments are, both when given alone and when combined. They're also looking to see how well they work compared to an existing immunotherapy treatment.

By taking part in this study, you would help researchers understand if these new combinations of immunotherapy medicines could become a helpful treatment for people with advanced urothelial cancer in the future. The information gathered will be important for developing new ways to fight this disease. This is a "Phase 2" study, which means it's one of the earlier stages of testing new medicines in people.

Key takeaways

This study is testing new immune treatments for advanced bladder cancer.
It's for people who can't have standard chemotherapy.
The research aims to find safer and more effective treatment options.
Treatment involves regular hospital visits for infusions and check-ups.
You'll be closely monitored for any side effects.
Your participation could help advance cancer treatment for others.

Who may be eligible?

This study is for adults generally aged 18 and over who have advanced bladder cancer (urothelial cancer) that has spread or grown significantly and hasn't been treated yet. Importantly, you must not be able to have standard platinum-based chemotherapy treatments, often because of other health reasons.

Your cancer must be a specific type called "transitional cell carcinoma" or a similar kind, and doctors need to be able to measure it on scans. You'll also need to be generally well enough to take part, meaning you can do most of your usual activities, and your important organs like your heart, liver, and kidneys need to be working properly. You cannot be pregnant or breastfeeding.

There are also some reasons why you might not be able to join. For example, if you have certain autoimmune diseases (where your immune system attacks your own body), a history of certain lung problems, or if your cancer has spread to your brain and is causing symptoms. Recent heart problems or serious infections like tuberculosis would also prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced urothelial cancer that has spread?
Have you *not* had prior treatment for your advanced cancer?
Have your doctors said you are not suitable for platinum-based chemotherapy?
Are you generally well enough to carry out most daily activities?
Do you not have certain serious ongoing health conditions like active autoimmune disease or recent heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given one of the study medications: either atezolizumab, tobemstomig, or a combination of tobemstomig and tiragolumab. These medicines are given into a vein (like a drip) over a period of time. You would have regular appointments at the hospital for these treatments, as well as for blood tests, scans (like CT scans) to check your cancer, and check-ups with the study team to see how you're feeling and to monitor for any side effects.

Your involvement would continue as long as the treatment is benefiting you and you are tolerating it well, or until the study doctor decides it's no longer the best option. After treatment finishes, you would still have follow-up visits or phone calls to monitor your health in the longer term. The total duration of your participation, including follow-up, can vary, but would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close medical attention from a specialist team. These new immunotherapies might help slow down or shrink your cancer. However, there are also potential risks; the medicines being tested might cause side effects, some of which could be serious or unexpected, as their full effects are still being studied. There's no guarantee the treatment will work for you. You will be monitored very closely for any problems, and you can withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cleveland Clinic
Verified postcode
Cleveland, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States
Macquarie University Hospital
Verified postcode
Macquarie Park, Australia
Lyell McEwin Hospital
Verified postcode
Adelaide, Australia
ICON Cancer Care Adelaide
Verified postcode
Kurralta Park, Australia
Hospital Universitario Evangelico De Curitiba
Verified postcode
Curitiba, Brazil
Hospital das Clinicas - UFRGS
Verified postcode
Porto Alegre, Brazil
Hospital de Amor Amazônia
Verified postcode
Porto Velho, Brazil
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Verified postcode
Santo André, Brazil
Hospital Alemao Oswaldo Cruz
Verified postcode
São Paulo, Brazil
Beijing Cancer Hospital
Verified postcode
Beijing, China
West China Hospital - Sichuan University
Verified postcode
Chengdu, China

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that usually starts in the lining of the bladder, but can also be found in other parts of the urinary system.

What is immunotherapy?

Immunotherapy is a treatment that uses your body's own immune system to help fight cancer cells.

Why is this study only for people who can't have chemotherapy?

This study focuses on patients who aren't able to have standard chemotherapy, usually due to other health conditions, to find new treatment options for them.

What are 'Phase 2' studies?

Phase 2 studies are an important stage where doctors test if a new treatment is safe and effective in a larger group of people, after earlier safety tests.

Will I know which treatment I'm getting?

You will be told by the study team whether you will know which specific treatment you are receiving, as this can vary between studies.