RecruitingPhase 2Phase 3NCT05770102

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

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.


Sponsor

Cancer Research UK

Enrollment

30 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Atezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD). Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB/MSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing atezolizumab (an immunotherapy) in patients of any age with cancers that have a high number of mutations (high TMB), are microsatellite instability-high (MSI-H), or carry a rare inherited DNA repair deficiency (CMMRD). It is part of the DETERMINE master protocol, which matches cancer patients to treatments based on their tumor's genetic features, regardless of cancer type. **You may be eligible if...** - Your tumor has been confirmed to have high tumor mutational burden (≥10 mutations/Mb), MSI-H, or CMMRD by genetic testing - You meet the eligibility criteria of the DETERMINE master protocol (NCT05722886) **You may NOT be eligible if...** - Your tumor does not have the required genetic markers - You do not meet the master protocol's general eligibility requirements - You have conditions that specifically contraindicate atezolizumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Adult patients will receive 1200 mg of atezolizumab intravenously every 21 days. Paediatric patients will receive atezolizumab at a dose of 15 mg/kg (maximum 1200 mg) every 21 days. Patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.


Locations(27)

Belfast City Hospital

Belfast, United Kingdom

University Hospital Birmingham

Birmingham, United Kingdom

Birmingham Children's Hospital

Birmingham, United Kingdom

Bristol Royal Hospital for Children

Bristol, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Cardiff Children's Hospital

Cardiff, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

The Beatson Hospital

Glasgow, United Kingdom

Royal Hospital for Children Glasgow

Glasgow, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Alder Hey Hospital

Liverpool, United Kingdom

University College London Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Great North Children's Hospital

Newcastle, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Churchill Hospital

Oxford, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom

Sheffield's Children's Hospital

Sheffield, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

The Royal Marsden Hospital

Sutton, United Kingdom

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NCT05770102


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