Active not recruitingPHASE3INTERVENTIONAL

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

This research study is for people with a specific type of oesophageal cancer called squamous cell carcinoma. This is when the cancer has been treated with chemotherapy and radiotherapy and hasn't grown back or spread. The study is investigating two experimental medications, tiragolumab and atezolizumab, which are given as infusions. Participants will receive either both new medicines, one new medicine and a placebo, or two placebos. A placebo looks like the real medicine but contains no active drug. The aim is to find out if these new treatments are safe and effective at preventing the cancer from progressing in people who can't have surgery.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

760

Start

28 Sep 2020

Estimated completion

31 Mar 2027

Esophageal Squamous Cell Carcinoma

What is this study about?

This study is for individuals diagnosed with a specific type of oesophageal cancer called squamous cell carcinoma. This is a cancer of the tube that carries food from your mouth to your stomach. You've already had a standard treatment called chemoradiotherapy, which combines chemotherapy drugs with radiation therapy. The good news is that after this treatment, your cancer hasn't grown or spread, and typically, surgery is not an option for your particular situation.

The main goal of this study is to see if combining two new experimental medicines, tiragolumab and atezolizumab, can help keep the cancer from coming back or getting worse. These medications are a type of immunotherapy, which means they work with your body's immune system to fight the cancer. We want to compare this combination to receiving only atezolizumab (with a dummy version of tiragolumab) or receiving dummy versions of both medicines (placebos).

You'll be randomly assigned to one of three groups, much like flipping a coin, to ensure a fair comparison. This helps us understand if these new treatments are safe and truly effective for people in your situation. By taking part, you'll be contributing to important research that could help future patients with oesophageal cancer.

Key takeaways

This study is for a specific type of oesophageal cancer that hasn't progressed after initial treatment.
It's testing new immunotherapy drugs (tiragolumab and atezolizumab) to prevent cancer recurrence.
Participation involves receiving one of three possible treatments via infusion.
You'll have regular hospital visits for treatment, tests, and monitoring.
This research hopes to find better ways to manage oesophageal cancer in the future.

Who may be eligible?

To be considered for this study, you'd generally need to be an adult at least 18 years old and have a confirmed diagnosis of oesophageal squamous cell carcinoma. Your cancer must have been treated with a combination of chemotherapy and radiotherapy, and it shouldn't have grown or spread since then. Importantly, surgery must not be an option for your cancer.

You should also be generally well and able to carry out your daily activities with little difficulty. The research team will need a sample of your cancer tissue taken before your previous treatment. They will also check your blood test results to make sure your organs are working properly.

There are also some reasons why you might not be able to join. For example, if you've already had certain types of immunotherapy medicines, or if you have an active autoimmune disease (where your body's immune system mistakenly attacks healthy cells). Serious side effects from your previous cancer treatment that haven't cleared up could also prevent you from participating, as could a history of certain lung conditions or other cancers within the last two years.

Quick self-check

Have I been diagnosed with oesophageal squamous cell carcinoma?
Has my cancer already been treated with chemotherapy and radiotherapy?
Has my cancer not grown or spread since that treatment?
Am I unable to have surgery for my cancer?
Am I generally well enough to participate in a study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of three treatment groups. This is like drawing lots; two groups will receive one or both of the investigational new medicines (tiragolumab and atezolizumab), while the third group will receive dummy versions of both (placebos). All treatments are given as infusions directly into your vein.

You'll have regular visits to the clinic for your infusions and check-ups. These visits will include physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Throughout the study, the research team will closely watch for any side effects. The total duration of your participation, including treatment and follow-up, will be explained by the study team, but generally involves regular appointments over several months, followed by longer-term check-ups.

Potential risks and benefits

While we hope that these new treatments might help prevent your cancer from returning or worsening, there's no guarantee. There may also be side effects, some of which could be serious, as is the case with any new medication. The study team will explain all known potential risks and monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (167)

Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, United States
Cancer Center of Kansas
Wichita, United States
Great Lakes Cancer Center
Williamsville, United States
Instituto de Investigaciones Metabolicas (Idim)
Buenos Aires, Argentina
Fundacion Favaloro
Buenos Aires, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Princess Alexandra Hospital
Woolloongabba, Australia
Austin Health
Heidelberg, Australia
St John of God Hospital
Subiaco, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria

+155 more sites — see the official record for the full list.

Common questions

What is oesophageal squamous cell carcinoma?

It's a type of cancer that starts in the cells lining the oesophagus, which is the food pipe leading to your stomach.

What is 'chemoradiotherapy'?

It's a standard cancer treatment that combines chemotherapy drugs (to kill cancer cells) with radiation therapy (using high-energy rays).

What does 'unresectable' mean?

It means surgery is not a suitable or recommended option to remove the cancer, either because of its location, size, or other health reasons.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active drug. It helps ensure a fair comparison in studies.

Will I know which treatment group I'm in?

No, you won't know which group you're in (whether you're getting the active drugs or the placebos) to make sure the study results are unbiased. This is called 'blinding'.