All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

This research study, called DETERMINE, is looking at a medicine named atezolizumab, which is already approved for treating several types of cancer in the UK. Doctors want to see if atezolizumab could also help people with different types of cancer that have specific genetic changes. These changes are known as 'high tumour mutational burden' (TMB-high), 'microsatellite instability-high' (MSI-high), or 'constitutional mismatch repair deficiency' (CMMRD). If the cancer has these particular features, the study aims to find out if atezolizumab is an effective treatment. This could open up new treatment options for both common and rare cancers in adults, teenagers, and children.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Cancer Research UK
Enrolment target
30
Start
25 Oct 2023
Estimated completion
01 Oct 2029

What is this study about?

This study is investigating a cancer drug called atezolizumab. This isn't a completely new drug; it's already approved and used in the UK for treating certain types of cancer, such as some lung cancers, bladder cancer, liver cancer, and a specific type of breast cancer. The reason it works for these cancers is because the cancer cells have particular natural changes, which scientists call 'high tumour mutational burden' (TMB-high), 'microsatellite instability-high' (MSI-high), or 'constitutional mismatch repair deficiency' (CMMRD).

Now, researchers want to find out if atezolizumab could also help people with *other* types of cancer that have these same specific genetic changes, even if the cancer itself is different. For example, some rare cancers, or less common forms of more common cancers, might have these features. If the study shows that atezolizumab is helpful for these additional cancer types, it could mean more treatment choices for patients in the future, including adults, teenagers, and children.

The DETERMINE programme, which this study is part of, aims to match existing cancer drugs to cancers that have specific molecular changes. The ultimate goal is to work with the NHS and the Cancer Drugs Fund to make these new treatment options available to patients if they prove to be effective and safe.

Key takeaways

  • This study is testing an approved cancer drug, atezolizumab, for new types of cancer.
  • It's for cancers with specific genetic markers: TMB-high, MSI-high, or CMMRD.
  • The study includes adults, teenagers, and children with these cancer types.
  • Participation involves screening, receiving atezolizumab, and follow-up.
  • The goal is to find new treatment options for patients with these cancer features.
  • You can stop participating at any time.

Who may be eligible?

To join this study, the main thing is that a doctor has diagnosed you with cancer, and tests have shown that your cancer has certain genetic features. These features are 'high tumour mutational burden' (TMB-high), 'microsatellite instability-high' (MSI-high), or 'constitutional mismatch repair deficiency' (CMMRD). These are specific changes in your cancer cells that indicate how the cancer might respond to certain treatments.

If you are a woman who could become pregnant, you would need to have a negative pregnancy test before starting treatment and agree to use effective birth control throughout the study and for five months after your last dose of the study drug. Men with partners who could become pregnant would also need to agree to use effective birth control during the same period.

Quick self-check
  • Have I been diagnosed with cancer?
  • Do my cancer cells have one of these features: high TMB, MSI-high, or CMMRD?
  • Am I a woman who could become pregnant and willing to use birth control?
  • Am I a man whose partner could become pregnant and willing to use birth control?

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, your first step will be a 'pre-screening' where a team of experts will review your cancer's genetic information to see if this study treatment might be a good fit. If it seems suitable, you'll go through a 'screening' phase. This involves providing blood samples and, in some cases, a small tissue sample (biopsy) for detailed research tests.

If you are eligible, you will then start receiving the study drug, atezolizumab. You will continue to take the drug for as long as it is helping, and you are not experiencing severe side effects, or until you choose to stop. During this treatment period, you will have regular visits to the clinic, where doctors will monitor your health and how you are responding to the treatment. You will also give blood samples at different times. After you finish taking the study drug, doctors will follow up with you every three months for two years to see how you are doing.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your cancer, especially if standard treatments haven't worked or if your cancer has these specific genetic features. However, like all medications, atezolizumab can cause side effects. These can vary from person to person, and the study team will monitor you closely for any unwanted effects. You should remember that joining a clinical trial is always your choice, and you are free to leave the study at any time, for any reason, without affecting your future medical care.

Locations (27)

  • Belfast City Hospital
    Belfast, United Kingdom· Not yet recruiting
  • University Hospital Birmingham
    Birmingham, United Kingdom· Recruiting
  • Birmingham Children's Hospital
    Birmingham, United Kingdom· Not yet recruiting
  • Bristol Royal Hospital for Children
    Bristol, United Kingdom· Recruiting
  • Bristol Haematology and Oncology Centre
    Bristol, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Cambridge, United Kingdom· Recruiting
  • Velindre Cancer Centre
    Cardiff, United Kingdom· Recruiting
  • Cardiff Children's Hospital
    Cardiff, United Kingdom· Not yet recruiting
  • Western General Hospital
    Edinburgh, United Kingdom· Recruiting
  • The Beatson Hospital
    Glasgow, United Kingdom· Recruiting
  • Royal Hospital for Children Glasgow
    Glasgow, United Kingdom· Recruiting
  • Leicester Royal Infirmary
    Leicester, United Kingdom· Recruiting

+15 more sites — see the official record for the full list.

Common questions

What is atezolizumab?

Atezolizumab is a cancer drug that helps your body's immune system fight cancer cells. It's already approved for some cancers in the UK.

What does TMB-high, MSI-high, or CMMRD mean?

These are specific genetic changes found in some cancer cells. They are like 'markers' that help doctors understand how a cancer might respond to certain treatments, like atezolizumab.

Will I get this drug if I join the study?

If you are found to be eligible after the screening tests, you will receive atezolizumab as the study treatment.

How long will I be on the treatment?

You will receive atezolizumab for as long as it is helping you and not causing severe side effects, or until you decide to stop.

Who can take part in this study?

Adults, teenagers, and children with certain types of cancer that have specific genetic changes (TMB-high, MSI-high, or CMMRD) may be eligible.

How to find out more

Aida Sarmiento Castro

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Pae…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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