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Looking for participantsPhase2/Phase3

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol

Sponsor: Cancer Research UK

NCT ID: NCT05722886

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Alectinib (drug), Atezolizumab (drug), Entrectinib (drug), Trastuzumab in combination with pertuzumab (drug)
How long the study runs
Study runs about 79 months (dates as stated)
About the drug or intervention
Alectinib — drug: Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. · Atezolizumab — drug: Adult patients will receive 1200 mg of atezolizumab intravenously every 21 days. · Entrectinib — drug: Adult and paediatric patients with body surface area (BSA) ≥1.51 m\^2 will receive entrectinib orally at a dose of 600 mg daily dose (three 200 mg capsules per day). · Trastuzumab in combination with pertuzumab — drug: The initial loading dose of trastuzumab is 8 mg/kg body weight followed thereafter by a maintenance dose of 6 mg/kg body weight administered intravenously every 21 days. · Vemurafenib in combination with cobimetinib — drug: Patients will receive vemurafenib at a dose of 960 mg (four tablets of 240 mg) orally on a twice daily schedule throughout a 28-day cycle. · Capmatinib — drug: Patients will receive capmatinib orally at a daily dose of 800 mg consisting of 400 mg (two 200 mg tablets) twice daily. · Dabrafenib in combination with trametinib — drug: Adult patients (≥18 years) will receive dabrafenib at a dose of 150 mg (two 75 mg tablets) twice daily (total daily dose 300 mg).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
Not specified
Who
All
Number of participants
825
Started
2023-03-01
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for haematological malignancy
  • • Phase2/Phase3 - 825 participants
  • • DETERMINE is an open-label phase II/III trial

Who can take part?

  • • Adults
  • • Diagnosed with haematological malignancy

Where?

  • • Belfast - Belfast City Hospital
  • • Birmingham - University Hospital Birmingham
  • • Birmingham - Birmingham Children's Hospital
  • • Bristol - Bristol Royal Hospital for Children
  • • +23 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Patients must have a cancer with an identified mutation. This could be found during routine testing or as part of another research programme. The DETERMINE trial will recruit adults, teenagers and children. If a drug is found to benefit a new patient group, the study team will work with the NHS and the Cancer Drugs Funds to see if these drugs can be available for patients in the future. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), additional records will be added to clinicaltrials.gov for each treatment arm.

More detail

DETERMINE is an umbrella-basket platform trial to evaluate the efficacy of licensed targeted therapies in rare\* adult, paediatric and teenage/young adult (TYA) cancers with actionable genomic alterations, including common cancers with rare actionable alterations. \*Rare is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and TYA cancers) or common cancers with rare alterations. The number of treatment arms opened will depend on the number of licensed medicines identified for inclusion. Each trial cohort 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. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), please refer to the references section for links to the individual treatment arm records. The main aims of the clinical trial arms are: * To describe the anti-cancer activity of licensed targeted drugs outside their licensed indication. * To assess the safety and adverse event (AE) profile of licensed, targeted anti-cancer drugs in the target population. * To understand biological mechanisms for response and resistance to targeted therapies. * To evaluate the quality of life (QoL) of target populations receiving the licensed, targeted anti-cancer drugs. This Master Screening Record will capture the number of patients with a cancer containing the appropriate genetic alteration that have been successfully allocated and consented to each arm. The trial results (according to the protocol defined outcome measures) will be reported per-arm for each treatment arm. The ultimate aim is to translate positive clinical findings to the NHS to provide new treatment options for rare adult, paediatric and TYA cancers.

Haematological MalignancySolid Tumour

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

Biomarkers mentioned

Have a negative

What the study is looking for

  • ✓exhausted (or declined) standard-of-care treatment options.
  • ✓or for whom no effective standard treatment is available.
  • ✓and whose disease has progressed or is refractory. Exceptional circumstances may apply as described in the protocol.
  • ✓Life expectancy of at least three months.
  • ✓Patients with objectively evaluable or cancer that can be measured on scans, according to an assessment method appropriate for their...

Who cannot take part

  • ✗At high medical risk, in the opinion of the Investigator, because of non-malignant systemic disease (including...
  • ✗Any other condition which, in the opinion of the local Investigator, would not be in the best interests of the patient.
See the full criteria
THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA OUTLINED BELOW AND WITHIN THE SPECIFIC TREATMENT ARM APPENDIX TO WHICH THEY ARE ENROLLED. Core Inclusion Criteria: 1. Any patient (adult patients or children and TYA as defined in each treatment arm appendix) with histologically proven locally advanced or metastatic cancer (solid tumour or haematological malignancy) who has: 1. exhausted (or declined) standard-of-care treatment options. 2. or for whom no effective standard treatment is available. 3. and whose disease has progressed or is refractory. Exceptional circumstances may apply as described in the protocol. 2. Diagnosis of a rare cancer harbouring an actionable genomic alteration, or common cancer types with rare actionable genomic alterations, that has been identified using a validated next-generation sequencing method and for which there is a relevant open treatment arm within the DETERMINE trial. 3. Life expectancy of at least three months. 4. Patients are able to provide written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up. For patients under 16 years old, the parent or legal guardian will be asked to provide written informed consent and the patient will be asked to provide age-appropriate assent (written or verbal, commensurate with age and level of understanding). 5. Patients with objectively evaluable or measurable disease, according to an assessment method appropriate for their cancer type. 6. Patients must provide a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow and/or trephine, lymph node or lump biopsy samples may be taken. For patients with haematological malignancies, a skin punch biopsy may also be taken. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status 2 may be considered on an individual basis) (adults), Karnofsky score ≥50% (TYA) or Lansky Play scales ≥50% (\<12 years). Please see specific treatment arm appendices for any variations on this criterion and for definitions of adult and paediatric populations. Note: Paediatric patients: patients with Central Nervous System (CNS) tumours and a stable neurological deficit may be eligible with a performance status below 50%, at the discretion of the Investigator. In such cases, the deficit must be stable for at least 7 days prior to trial enrolment and be assessed by the local investigator as due to tumour or due to a post-surgical AE. 8. Women of childbearing potential are eligible provided that they meet the following criteria: * Have a negative serum or urine pregnancy test before enrolment and * Agree to the birth control methods and duration of use of those methods, as specified in each treatment arm appendix. 9. Male patients with partners of childbearing potential are eligible provided that they agree to the birth control methods and duration of use of those methods, as specified in each treatment arm appendix. Core exclusion criteria: 1. Ongoing AEs Common Terminology Criteria of Adverse Events (CTCAE) Grade ≥2 attributable to previous anti-cancer treatments. Exceptions to this are any clinically stable AEs, which in the opinion of the Investigator should not exclude the patient. 2. At high medical risk, in the opinion of the Investigator, because of non-malignant systemic disease (including active uncontrolled infection). 3. Female patients who are pregnant, breastfeeding or planning to become pregnant or male patients with a partner who is a woman of childbearing potential and is planning to become pregnant during the trial or following the last dose of IMP, as specified in each treatment arm appendix. 4. Is (or plans to be) a patient in another interventional clinical trial, whilst taking part in this trial. Participation in an observational trial which does not involve administration of an Investigational Medicinal Product (IMP) and which, in the opinion of the local Investigator, would not place an unacceptable burden on the patient would be acceptable e.g. sample collection\* or QoL studies. \*for paediatric patients participating in other studies involving tissue/circulating tumour (ct) DNA/other blood collection, consideration would need to be given to the total blood volumes collected (as per the European Medicines Agency blood volume limits for children). 5. Co-administration of anti-cancer therapies other than those administered in this trial (with the exception of lifelong hormone suppression such as luteinising hormone agonists/analogues in prostate cancer). 6. Radiotherapy (except for palliative reasons) or chemotherapy, endocrine therapy (except when given for conditions other than malignant disease; e.g. thyroid replacement for hypothyroidism, hydrocortisone for cortisol deficiency/panhypopituitarism), nitrosoureas, mitomycin-C, immunotherapy and molecularly targeted agents or other IMPs within 4 weeks or 5 half-lives (whichever is the shorter). 7. Rapidly progressing or symptomatically deteriorating brain metastases. 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 the 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 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. 8. Any other condition which, in the opinion of the local Investigator, would not be in the best interests of the patient.

Where Is This Study? (27 UK sites)

Belfast City Hospital

Belfast BT9 7AB, United Kingdom

Recruiting
Site contact (verified)
Vicky Coyle, ProfPrincipal Investigator
Vicky Coyle, ProfV.Coyle@qub.ac.uk

University Hospital Birmingham

Birmingham B15 2TT, United Kingdom

Recruiting
Site contact (verified)
Gary Middleton, ProfPrincipal Investigator

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Gerard Millen, DrPrincipal Investigator

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

Recruiting
Site contact (verified)
Antony Ng, DrPrincipal Investigator

Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting
Site contact (verified)
Antony Ng, DrPrincipal Investigator

Addenbrooke's Hospital

Cambridge CB2 OQQ, United Kingdom

Recruiting
Site contact (verified)
Bristi Basu, DrPrincipal Investigator

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
Robert Jones, DrPrincipal Investigator

Cardiff Children's Hospital

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Madeline Adams, DrPrincipal Investigator

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Stefan Symeonides, DrPrincipal Investigator

The Beatson Hospital

Glasgow G12 OYN, United Kingdom

Recruiting
Site contact (verified)
Patricia Roxburgh, DrPrincipal Investigator

Royal Hospital for Children Glasgow

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Milind Ronghe, DrPrincipal Investigator

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Harriet Walter, DrPrincipal Investigator

Alder Hey Hospital

Liverpool L14 5AB, United Kingdom

Recruiting
Site contact (verified)
Lisa Howell, DrPrincipal Investigator

University College London Hospital

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Martin Forster, ProfPrincipal Investigator

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
James Spicer, DrPrincipal Investigator

Great Ormond Street Hospital

London WC1N 3JH, United Kingdom

Recruiting
Site contact (verified)
Darren Hargrave, DrPrincipal Investigator

Royal Manchester Children's Hospital

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Guy Makin, DrPrincipal Investigator

The Christie Hospital

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Matthew KrebsPrincipal Investigator

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Site contact (verified)
Dan Palmer, DrPrincipal Investigator

Great North Children's Hospital

Newcastle NE1 4LP, United Kingdom

Recruiting
Site contact (verified)
Alastair Greystoke, DrPrincipal Investigator

Freeman Hospital

Newcastle NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Alastair Greystoke, DrPrincipal Investigator

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Sarah Pratap, DrPrincipal Investigator

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Sarah Pratap, DrPrincipal Investigator

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

Recruiting
Site contact (verified)
Sarah Danson, DrPrincipal Investigator

Sheffield's Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Site contact (verified)
Daniel Yeomanson, DrPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Juliet Gray, ProfPrincipal Investigator

The Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Lynley Marshall, DrPrincipal Investigator

How to Get in Touch

Aida Sarmiento Castro

Sponsor contact

CONTACT

+44 207 242 0200 determine@cancer.org.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-06