AzTrials
AzTrials

MalignancyPhase 2/3DETERMINENCT05770102

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

A Phase 2/3 study testing Atezolizumab in people with Malignancy and Malignant Neoplasm, run by Cancer Research UK at 27 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
27 sitesUnited Kingdom
Study dates
25 Oct 2023to Oct 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut/Mb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut/Mb may be discussed in an MTB meeting. TMB ≥19 mut/Mb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.
  • Women of childbearing potential are eligible provide they meet the following criteria:
  • Have a negative serum or urine pregnancy test before enrolment and;
  • Agree to use one form of effective birth control method such as:
  • combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation ([oral, intravaginal or transdermal]);
  • progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);
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  • intrauterine device (IUD),
  • intrauterine hormone-releasing system (IUS),
  • bilateral tubal occlusion,
  • vasectomised partner,
  • sexual abstinence,
  • male or female condom with or without spermicide;
  • cap, diaphragm or sponge with spermicide.
  • Effective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.
  • Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:
  • Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.
  • Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.
  • Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.
  • All male patients must refrain from donating sperm for the same period.
  • Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken.
  • ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.
  • PAEDIATRIC PATIENTS (<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.
  • Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.

Who cannot join

  • Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.
  • Patients with rapidly progressing or symptomatically deteriorating brain metastases and/or leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and/or stereotactic radiosurgery at least 14 days prior to the start of IMP administration.
  • Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.
  • Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.
  • History or clinical evidence of current inflammatory lung disease:
  • History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
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  • Evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.
  • Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).
  • Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:
  • Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.
  • Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.
  • Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.
  • Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.
  • Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  • History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.
  • Known hypersensitivity to Chinese hamster ovary cell products.
  • Known hypersensitivity to atezolizumab or any of the excipients.
  • Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.
  • Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.
  • Patients with a cerebrovascular event (including stroke or transient ischaemic attacks [TIA]) or cardiovascular event (including acute myocardial infarction [MI]) within three months before the first dose of atezolizumab.
  • Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages <3 mm may be considered.
  • Patients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.
  • Prior allogeneic stem cell or solid organ transplantation on immunosuppression.
  • Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.
  • Uncontrolled diabetes.
  • Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.
  • Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aida Sarmiento Castro contact

+44 207 242 0200

determine@cancer.org.uk

27 sites in 1 country

United Kingdom27 sites, 27 recruiting

  • Belfast City Hospital

    Belfast, BT9 7AB

    Vicky Coyle, Prof, V.Coyle@qub.ac.uk

    Vicky Coyle, Prof

    Not yet recruiting

  • University Hospital Birmingham

    Birmingham, B15 2TT

    Gary Middleton, Prof, 0121 371 3573, G.Middleton@bham.ac.uk

    Gary Middleton, Prof

    Recruiting

  • Birmingham Children's Hospital

    Birmingham

    Gerard Millen, Dr, 07921843607, g.millen@nhs.net

    Gerard Millen, Dr

    Not yet recruiting

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

    Antony Ng, Dr, 0117 342 8044, Antony.Ng@uhbw.nhs.uk

    Antony Ng, Dr

    Recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    Antony Ng, Dr, 0117 342 8044, Antony.Ng@uhbw.nhs.uk

    Antony Ng, Dr

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 OQQ

    Bristi Basu, Dr, 01223 596105, bb313@medschl.cam.ac.uk

    Bristi Basu, Dr

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Robert Jones, Dr, 02920 615888 ext. 6327, Robert.Hugh.Jones@wales.nhs.uk

    Robert Jones, Dr

    Recruiting

  • Cardiff Children's Hospital

    Cardiff, CF14 4XW

    Madeline Adams, Dr, +442921842285, madeline.adams@wales.nhs.uk

    Madeline Adams, Dr

    Not yet recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Stefan Symeonides, Dr

    Stefan Symeonides, Dr

    Recruiting

  • The Beatson Hospital

    Glasgow, G12 OYN

    Patricia Roxburgh, Dr, 0141 301 7118, Patricia.Roxburgh@glasgow.ac.uk

    Patricia Roxburgh, Dr

    Recruiting

  • Royal Hospital for Children Glasgow

    Glasgow, G51 4TF

    Milind Ronghe, Dr, 0141 452 6692, Milind.Ronghe@ggc.scot.nhs.uk

    Milind Ronghe, Dr

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Olubukola Ayodele, Dr, 0116 2587601, olubukola.ayodele@uhl-tr.nhs.uk

    Olubukola Ayodele, Dr

    Recruiting

  • Alder Hey Hospital

    Liverpool, L14 5AB

    Lisa Howell, Dr, 0151 293 3679, Lisa.Howell@alderhey.nhs.uk

    Lisa Howell, Dr

    Recruiting

  • University College London Hospital

    London, NW1 2BU

    Martin Forster, Prof, 020 3447 5085, M.Forster@ucl.ac.uk

    Martin Forster, Prof

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    James Spicer, Dr, 020 7188 4260, james.spicer@kcl.ac.uk

    James Spicer, Dr

    Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH

    Darren Hargrave, Dr, 0207 813 8525, Darren.hargrave@gosh.nhs.uk

    Darren Hargrave, Dr

    Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

    Guy Makin, Dr, 0161 701 8419, Guy.Makin@mft.nhs.uk

    Guy Makin, Dr

    Not yet recruiting

  • The Christie Hospital

    Manchester, M20 4BX

    Matthew Krebs, Dr, 0161 918 7672, matthew.krebs@nhs.net

    Matthew Krebs, Dr

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Dan Palmer, Dr, 0151 706 4172 / 0151 706 4177, daniel.palmer@liverpool.ac.uk

    Dan Palmer, Dr

    Recruiting

  • Great North Children's Hospital

    Newcastle, NE1 4LP

    Alastair Greystoke, Dr, 0191 2138476, Alastair.Greystoke@newcastle.ac.uk

    Alastair Greystoke, Dr

    Recruiting

  • Freeman Hospital

    Newcastle, NE7 7DN

    Alastair Greystoke, Dr, 0191 2138476, Greystoke@newcastle.ac.uk

    Alastair Greystoke, Dr

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    Sarah Pratap, Dr, 01865 235273, Sarah.Pratap@ouh.nhs.uk

    Sarah Pratap, Dr

    Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Sarah Pratap, Dr, 01865 235273, Sarah.Pratap@ouh.nhs.uk

    Sarah Pratap, Dr

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ

    Sarah Danson, Dr, 0114 226 5068, s.danson@sheffield.ac.uk

    Sarah Danson, Dr

    Recruiting

  • Sheffield's Children's Hospital

    Sheffield, S10 2TH

    Daniel Yeomanson, Dr, 01142717366, danyeomanson@nhs.net

    Daniel Yeomanson, Dr

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Juliet Gray, Prof, 0238 120 6639, Juliet.Gray@uhs.nhs.uk

    Juliet Gray, Prof

    Recruiting

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

    Lynley Marshall, Dr, 0208 661 3678, LynleyVanessa.Marshall@icr.ac.uk

    Lynley Marshall, Dr

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

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).

Read more

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.

Read the detailed description

DETERMINE Treatment Arm 02 (atezolizumab) aims to evaluate the efficacy of atezolizumab in adult, paediatric and teenage/young adult (TYA) patients with rare* cancers with high TMB or high MSI or proven CMMRD disposition and in common cancers where high TMB/MSI or proven CMMRD is considered to be infrequent.

*Rare is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and teenagers/young adult cancers) or common cancers with rare alterations.

This treatment arm has a target sample size of 30 evaluable patients. Sub-cohorts may be defined and further expanded to a target of 30 evaluable patients each.

The ultimate aim is to translate positive clinical findings to the NHS (Cancer Drugs Fund) to provide new treatment options for rare adult, paediatric and TYA cancers.

OUTLINE:

Pre-screening: The Molecular Tumour Board (MTB) makes a treatment recommendation for the participant based on molecularly-defined cohorts.

Screening: Consenting patients undergo biopsy and collection of blood samples for research purposes.

Treatment: Patients will receive atezolizumab until disease progression without clinical benefit, unacceptable adverse events (AEs) or withdrawal of consent. Patients will also undergo collection of blood samples at various intervals while receiving treatment and at EoT.

After completion of study treatment, patients are followed up every 3 months for 2 years.

THE DETERMINE TRIAL MASTER (SCREENING) PROTOCOL:

Please see DETERMINE Trial Master (Screening) Protocol record (NCT05722886) for information on the DETERMINE Trial Master Protocol and applicable documents.

Being tested
Atezolizumab
Keywords
Adult, Antineoplastic Agents, Atezolizumab, Cancer, Child, Malignancy, Malignant Neoplasms, Molecular Targeted Therapy, Neoplasms by Histologic Type, Neoplasms by Site, Paediatric, Precision Medicine, Rare, Tumour-agnostic, Young adult
Medical subject headings
Neoplasms, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Colorectal Neoplasms, Endometrial Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    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.

Study groups in NCT05770102
Study groupRoleWhat they receive
Treatment Arm 02: AtezolizumabExperimentalThis atezolizumab treatment arm is for adult, paediatric and TYA patients with cancers with high TMB or high MSI or proven (previously diagnosed) CMMRD.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response (OR)

    An OR is defined as the confirmed occurrence of either a Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 criteria (or immune related [ir]-RECIST or standard imaging criteria for specific disease e.g. Response Evaluation in Neuro Oncology criteria [RANO]). In patients with leukaemia, OR will be defined as the occurrence of CR, CRi (CR incomplete neutrophil recovery) or CRp (CR with incomplete platelet recovery). The trial will report the proportion of patients with an OR and 95% credible interval.

    Measured: Disease assessments to be performed up to 24 weeks from the start of trial treatment.

  2. Durable Clinical Benefit (DCB)

    DCB is defined as the absence of disease progression for at least 24 weeks from the start of trial treatment according to RECIST Version 1.1 criteria (or ir-RECIST or standard imaging criteria for specific disease e.g. RANO criteria) and, where relevant (e.g. for haematological malignancies), by standard bone marrow response assessment criteria. Alternative definitions of DCB based on different time points may be pre-specified for particular sub-cohorts if 24 weeks is not clinically relevant. The trial will report the proportion of patients with a DCB and 95% credible interval.

    Measured: Disease assessments to be performed up to 24 weeks from the start of trial treatment.

Secondary outcomes (13)

  1. Duration of response (DR)

    DR is defined as the time from the date of the first confirmed CR or PR according to RECIST 1.1 or ir-RECIST or standard imaging criteria for specific disease e.g. RANO criteria to the date of disease progression. The trial will report the median DR and 95% credible interval.

    Measured: Disease assessment every 2 cycles of atezolizumab (each cycle is 21 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of atezolizumab for up to 2 years.

  2. Best percentage change in sum of target lesion / index lesion diameters (PCSD)

    PCSD is defined as the greatest decrease or least increase in the sum of target lesion diameters (RECIST) or index lesion diameters (irRECIST) as a percentage compared to the baseline measurement. The trial will report the mean PCSD and 95% credible interval.

    Measured: Disease assessment every 2 cycles of atezolizumab (each cycle is 21 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of atezolizumab for up to 2 years.

  3. Time to treatment discontinuation (TTD)

    TTD is defined as the time from date of starting trial treatment to date of discontinuing trial treatment, in days estimated by the median of the posterior inverse gamma probability distribution. The trial will report the median TTD and 95% credible interval.

    Measured: From first dose of atezolizumab to discontinuation of trial treatment up to 5 years.

  4. Progression-Free Survival time (PFS)

    PFS is defined as the time from date of starting trial treatment to date of progression or date of death without a previous progression recorded estimated by the median of the posterior inverse gamma probability distribution.

    Measured: Disease assessment every 2 cycles of atezolizumab (each cycle is 21 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of atezolizumab for up to 2 years.

  5. Time to Progression (TTP)

    TTP is defined as the time from date of starting trial treatment to date of progression or date of death without recorded progression censored rather than events. The trial will report the median TTP and 95% credible interval.

    Measured: Disease assessment every 2 cycles of atezolizumab (each cycle is 21 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of atezolizumab for up to 2 years.

  6. Growth Modulation Index (GMI)

    GMI is defined as the ratio of TTP with the trial protocol treatment to TTP on the most recent prior line of therapy. The trial will report the mean GMI and 95% credible interval.

    Measured: Disease assessment every 2 cycles of atezolizumab (each cycle is 21 days) and at EoT. After 24 weeks, it can be done every 12 weeks, on discussion with Sponsor. Follow-up visits are every 3 months after last dose of atezolizumab for up to 2 years.

  7. Overall Survival time (OS)

    OS is defined as the time from date of starting trial treatment to date of death from any cause estimated by the median of the posterior normal probability distribution.

    Measured: Time of death or up to 2 years after the EoT visit.

  8. Occurrence of at least one Suspected Unexpected Serious Adverse Reaction (SUSAR)

    The trial will report the number of patients who experience at least one SUSAR to atezolizumab.

    Measured: From the time of consent until 90 days after last dose of atezolizumab (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.

  9. Occurrence of at least one Grade 3, 4 or 5 atezolizumab related AE

    Number of patients who experience at least one atezolizumab related Grade 3, 4 or 5 AE according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.

    Measured: From the time of consent until 90 days after last dose of atezolizumab (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.

  10. EORTC-QLQ-C30 Standardised Area Under Summary Score Curve (QLQSAUC) in adult patients

    For adult populations, multiple measures of Quality of Life (QoL) will be generated from patient completion of the European Organisation for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30) questionnaire (15 measures). For each patient the Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean QLQSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 21 days) and at EoT visit (up to 5 years).

  11. EQ-5D Standardised Area Under Index Value Curve (EQ5DSAUC) in adult patients.

    For adult populations, two measures of QoL will be generated from patient completion of the EQ-5D-5L questionnaire. For each measure, scores based on responses from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean EQ5DSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 21 days) and at EoT visit (up to 5 years).

  12. Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in paediatric patients.

    For paediatric populations multiple measures of QoL will be generated from patient completion of the PedsQL 4.0 (4 measures). The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean PedsSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 21 days) and at EoT visit (up to 5 years).

  13. Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in parents of paediatric patients.

    For paediatric populations multiple measures of QoL will be generated from patient's parent completion of the PedsQL 4.0 (4 measures). The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame. The trial will report the mean PedsSAUC and 95% credible interval.

    Measured: QoL surveys performed prior to inclusion, every cycle (each cycle is 21 days) and at EoT visit (up to 5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start25 Oct 2023
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05770102
Sponsor's protocol ID
CRUKD/21/004 - Treatment Arm 2
Other IDs
IRAS ID: 1004057
Acronym
DETERMINE
Status last verified
Nov 2025
First submitted
22 Feb 2023
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual de-identified patient data will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.

Publications

  • Robinson MD, Wheatley R, Foster L, Jamdar S, Siriwardena AK, Lamarca A, Hubner R, Valle JW, McNamara MG. Intrahepatic Cholangiocarcinoma With Extrahepatic Metastasis and High Tumor Mutation Burden: Case of Complete Pathological Response to Cisplatin/Gemcitabine/Pembrolizumab. JCO Precis Oncol. 2024 Apr;8:e2300572. doi: 10.1200/PO.23.00572. No abstract available.

    PubMed 38662981

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Atezolizumab in people with Malignancy and Malignant Neoplasm, run by Cancer Research UK at 27 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aida Sarmiento Castro (+44 207 242 0200, determine@cancer.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) (time frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05770102, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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