Actively Recruiting

Phase 2
Phase 3
All Genders
NCT05770102

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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