Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE II, OPEN LABEL, RANDOMIZED, NON-COMPARATIVE COHORTS STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN (TMB-H) OR MICROSATELLITE INSTABILITY (MSI-H) (IMperator)

This research study, called IMperator, is for adults with certain solid cancers that have been removed during an operation. Doctors want to find out if giving two medicines, atezolizumab (Tecentriq) or atezolizumab teamed with tiragolumab, after surgery can help prevent the cancer from returning. They are looking at specific cancers that have a higher chance of coming back or have certain genetic features. This is a Phase II study, meaning they are checking how well the treatments work and what side effects they might cause. The main goal is to see how many people remain cancer-free 24 months after starting the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Roche Farma S.A.

Enrolment target

Start

17 May 2024

Solid tumors

What is this study about?

This study is called IMperator and it's looking into new ways to treat certain solid cancers. 'Solid cancers' are growths that form a lump, unlike blood cancers. The study focuses on people who have already had their cancer removed by surgery. Even after surgery, there's a chance the cancer could come back, especially if it's considered to have a 'medium to high risk' of returning, or if the cancer cells have certain features called 'high tumor mutational burden' (TMB-H) or 'microsatellite instability' (MSI-H).

The researchers want to see if giving two specific medicines, atezolizumab (also known as Tecentriq) or atezolizumab combined with another medicine called tiragolumab, after surgery can help stop the cancer from coming back. These medicines work with your body's immune system to fight cancer cells. The study is comparing these treatments to see which is more effective at keeping the cancer away.

This is a 'Phase II' study, which means it's still in the earlier stages of testing new treatments. The main thing they want to find out is how many people are still free from cancer at 24 months (two years) after they start the study treatment. They will also look at how long people live overall, what side effects might happen, and how these medicines affect the cancer at a genetic level.

Key takeaways

This study explores new treatments to prevent cancer recurrence after surgery.
It focuses on specific solid cancers with higher risk of return or certain genetic markers.
Two medicines, atezolizumab (Tecentriq) and tiragolumab, are being investigated.
The main goal is to see how many people remain cancer-free after 24 months.
Participation involves regular clinic visits, infusions, and health monitoring.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, regardless of whether they are male or female.

To be considered for this study, you must have a type of solid cancer that has recently been removed by surgery. Your doctors will also need to confirm that your cancer has a medium to high chance of coming back, or it has specific features in its cells called 'high tumor mutational burden' (TMB-H) or 'microsatellite instability' (MSI-H). These are details your cancer specialist can check.

There will be other health checks and tests to make sure the study treatment is suitable and safe for you, as is standard practice for all clinical trials.

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 old or older?
Have you recently had surgery to remove a solid cancer?
Has your doctor told you your cancer has an intermediate-high risk of returning, or has specific features like TMB-H or MSI-H?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. This involves various tests and scans. If you are eligible, you would then be randomly assigned to receive either atezolizumab by itself, or atezolizumab along with tiragolumab. Both medicines are given through an infusion into your vein.

You would have regular appointments for treatment and check-ups, which include blood tests, scans, and physical examinations. These visits will help doctors monitor how you are doing, how the treatment is working, and if you are experiencing any side effects. The study aims to follow participants for several years, looking at whether the cancer returns, your general health, and any new illnesses. The total duration of your active treatment would be decided by the study doctors, and you would then have follow-up appointments.

Potential risks and benefits

Taking part in a study like this could offer the potential benefit of receiving new treatments that might help prevent your cancer from returning. However, as with all medicines, there are potential risks, including side effects from the treatments. These side effects can vary from mild to severe, and the study team will carefully monitor you for them. You will be given detailed information about all known potential side effects. Remember, participating in any clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What kind of cancers is this study for?

This study is for people who have solid cancers (cancers that form a lump) that have recently been surgically removed and are at intermediate-to-high risk of coming back, or have specific genetic features (TMB-H or MSI-H).

What are atezolizumab and tiragolumab?

These are medicines designed to work with your body's immune system to help fight cancer cells. They are given as infusions into a vein.

What does 'Disease Free Survival rate at 24 months' mean?

It means the percentage of people in the study who are still free from their cancer, haven't developed a new cancer, or haven't died from any cause, two years after they started the study treatment.

Will I know which treatment I'm receiving?

Yes, this is an 'open label' study, which means both you and your study doctor will know which treatment you are receiving.

Is this a new treatment approach?

Yes, this is a 'Phase II' study, which means it's an earlier stage of research designed to see how well these new treatments work and what side effects they might have for people with these specific types of cancer after surgery.