Actively Recruiting
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
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
27
Research Sites
309 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cancer with high tumor mutational burden (≥10 mut/Mb), high microsatellite instability, or proven constitutional mismatch repair deficiency
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for 5 months after treatment
- Male patients with partners of childbearing potential must agree to use barrier contraception or abstinence during treatment and refrain from sperm donation
- Ability and willingness to undergo fresh tissue biopsy and blood sample collection
- Adequate organ function for adult and pediatric patients as defined in the protocol
- Stable thyroid function or on stable thyroxine replacement therapy
You will not qualify if you...
- Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma, or triple negative breast cancer
- Rapidly progressing or worsening brain metastases or leptomeningeal disease; unstable primary brain or CNS tumors
- Women who are pregnant, breastfeeding, or planning pregnancy during or within 5 months after treatment
- History or evidence of inflammatory lung disease or active pneumonitis
- Active autoimmune disease requiring systemic immunomodulatory therapy
- Ongoing lung diseases posing safety risks (e.g., active tuberculosis)
- Use of systemic immunomodulatory agents within 14 days before trial entry (with some exceptions)
- Positive for hepatitis B, hepatitis C, or HIV infection
- History of severe allergic reactions to antibodies or immune checkpoint inhibitors
- Hypersensitivity to Chinese hamster ovary cell products or atezolizumab
- Live vaccine administration within 28 days prior or planned during treatment
- Significant cardiac conditions or recent cardiovascular/cerebrovascular events
- Prior allogeneic stem cell or organ transplant on immunosuppression
- Prior treatment with similar drugs unless resistance profile supports use
- Uncontrolled diabetes
- Any condition or treatment interfering with trial participation or safety
- Severe infection within 4 weeks or recent antibiotic use within 2 weeks prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Not Yet Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom
Not Yet Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
5
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
6
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Actively Recruiting
7
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
8
Cardiff Children's Hospital
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
9
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
10
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
11
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
12
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
13
Alder Hey Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
14
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
15
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
16
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
17
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
18
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
19
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
20
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
21
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
22
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
23
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
24
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
25
Sheffield's Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
26
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
27
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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