Actively Recruiting
DETERMINE Trial: Atezolizumab for Adults, Pediatric, and Teenage/Young Adult Patients With Cancers Showing High Tumor Mutational Burden, MSI-high, or Proven CMMRD
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
27
Research Sites
N/A
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
Researchers are evaluating the drug atezolizumab in a clinical trial for adult, pediatric, and teenage/young adult patients with rare cancers or common cancers showing specific genetic changes called high tumor mutational burden (TMB), high microsatellite instability (MSI), or proven constitutional mismatch repair deficiency (CMMRD). Atezolizumab is already approved for several cancer types, and this trial aims to see if it can be useful for other cancers with these genetic features. This trial is part of the DETERMINE program, which studies targeted therapies for rare cancers or cancers with specific mutations. Participants who qualify will receive atezolizumab treatment, given intravenously every 21 days. Adults receive 1200 mg per dose, while pediatric patients receive 15 mg/kg (up to 1200 mg). Treatment continues until the cancer progresses without benefit, unacceptable side effects occur, or the patient chooses to stop. Before treatment, patients undergo biopsy and blood sample collection. Blood samples are also collected during treatment and at the end of treatment. After treatment ends, patients will be followed up every 3 months for 2 years. During the study, patients will have regular disease assessments, including scans every two treatment cycles (each cycle is 21 days) and at the end of treatment, with less frequent assessments after 24 weeks. Quality of life questionnaires will be completed regularly. Researchers will monitor treatment response, duration of response, survival, and any serious side effects. Follow-up for survival and safety continues for up to 2 years after treatment ends, with some safety monitoring extending up to 5 years. The trial aims to provide evidence to support wider access to this treatment through the NHS if results are positive.
CONDITIONS
Brief 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 mutations/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 contraception during and for five months after treatment.
- Male patients with partners of childbearing potential must agree to use barrier contraception or abstinence during treatment and ensure partners use effective contraception.
- Ability and willingness to undergo fresh tissue biopsy and provide blood samples for research.
- Adults (≥18 years) and pediatric patients (<18 years) must have adequate organ function as defined in the protocol.
- Stable thyroid function; patients on stable thyroxine replacement are allowed.
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 symptomatically worsening brain metastases or leptomeningeal disease.
- Pregnant, breastfeeding, or planning pregnancy during the trial or within five months after last dose.
- History or evidence of current inflammatory lung disease such as idiopathic pulmonary fibrosis or active pneumonitis.
- Active autoimmune disease requiring systemic immunomodulatory therapy, except stable hormone replacement.
- Ongoing lung conditions posing safety risks.
- Recent use of systemic immunomodulatory agents except certain low-dose or acute uses.
- Positive for hepatitis B, hepatitis C, or HIV infections.
- History of severe allergic reactions to antibodies or immune checkpoint inhibitors.
- Known hypersensitivity to atezolizumab or its components.
- Recent live vaccine administration or planned need during the treatment period.
- Significant cardiac conditions or recent cerebrovascular or cardiovascular events.
- Prior allogeneic stem cell or organ transplant requiring immunosuppression.
- Prior treatment with similar drugs unless resistance profile suggests sensitivity.
- Uncontrolled diabetes.
- Any condition or treatment that may interfere with trial conduct or pose unacceptable risk.
- Severe infection or recent antibiotic use within specified timeframes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for biopsy and blood sample collection
Duration - Until disease progression or withdrawal
Participants receive atezolizumab intravenously every 21 days until disease progression without clinical benefit, unacceptable adverse events, or withdrawal of consent. Blood samples are collected at various intervals during treatment and at the end of treatment.
Infusions every 3 weeks with regular blood sample collections and disease assessments every 6 weeks (every 2 cycles)
Duration - Up to 2 years
Participants are followed up every 3 months for 2 years after completing study treatment to monitor health and outcomes.
Follow-up visits every 3 months
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
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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