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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (27 UK sites)
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
University Hospital Birmingham
Birmingham B15 2TT, United Kingdom
Birmingham Children's Hospital
Birmingham B4 6NH, United Kingdom
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 OQQ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Cardiff Children's Hospital
Cardiff CF14 4XW, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Beatson Hospital
Glasgow G12 OYN, United Kingdom
Royal Hospital for Children Glasgow
Glasgow G51 4TF, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Alder Hey Hospital
Liverpool L14 5AB, United Kingdom
University College London Hospital
London NW1 2BU, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
Great Ormond Street Hospital
London WC1N 3JH, United Kingdom
Royal Manchester Children's Hospital
Manchester M13 9WL, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Great North Children's Hospital
Newcastle NE1 4LP, United Kingdom
Freeman Hospital
Newcastle NE7 7DN, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
Sheffield's Children's Hospital
Sheffield S10 2TH, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Aida Sarmiento Castro
Sponsor contactCONTACT
