Could old drugs beat rare cancers? new trial aims to find out

NCT ID NCT05722886

Disease control Sponsor: Cancer Research UK Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

The DETERMINE trial is testing whether drugs already approved for some cancers can help people with rare cancers or common cancers that have rare genetic mutations. It will enroll 825 adults, teenagers, and children whose cancers have specific DNA changes. The goal is to find new uses for existing targeted therapies and make them available through the NHS if they work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: targeted therapies (e.g., alectinib, atezolizumab)
What this could lead to: If successful, this could expand treatment options for people with rare cancers or uncommon genetic mutations, potentially making existing drugs available to new patient groups.
What could go wrong: This is an early-stage platform trial testing many drugs across many cancer types. Not all drugs will work for every mutation, and results may take years to confirm. Side effects from the drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 825 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lymphoproliferative syndrome neoplasm Neoplasms by Histologic Type Neoplasms by Site

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haematological malignancy Solid tumour

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

27 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Addenbrooke's Hospital
RECRUITING

Cambridge, CB2 OQQ, United Kingdom
Alder Hey Hospital
RECRUITING

Liverpool, L14 5AB, United Kingdom
Belfast City Hospital
RECRUITING

Belfast, BT9 7AB, United Kingdom
Birmingham Children's Hospital
NOT_YET_RECRUITING

Birmingham, B4 6NH, United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING

Bristol, BS2 8ED, United Kingdom
Bristol Royal Hospital for Children
RECRUITING

Bristol, BS2 8BJ, United Kingdom
Cardiff Children's Hospital
RECRUITING

Cardiff, CF14 4XW, United Kingdom
Churchill Hospital
RECRUITING

Oxford, OX3 7LE, United Kingdom
Clatterbridge Cancer Centre
RECRUITING

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Freeman Hospital
RECRUITING

Newcastle, NE7 7DN, United Kingdom
Great North Children's Hospital
RECRUITING

Newcastle, NE1 4LP, United Kingdom
Great Ormond Street Hospital
RECRUITING

London, WC1N 3JH, United Kingdom
Guy's Hospital
RECRUITING

London, SE1 9RT, United Kingdom
John Radcliffe Hospital
RECRUITING

Oxford, OX3 9DU, United Kingdom
Leicester Royal Infirmary
RECRUITING

Leicester, LE1 5WW, United Kingdom
Royal Hospital for Children Glasgow
RECRUITING

Glasgow, G51 4TF, United Kingdom
Royal Manchester Children's Hospital
RECRUITING

Manchester, M13 9WL, United Kingdom
Sheffield's Children's Hospital
RECRUITING

Sheffield, S10 2TH, United Kingdom
Southampton General Hospital
RECRUITING

Southampton, SO16 6YD, United Kingdom
The Beatson Hospital
RECRUITING

Glasgow, G12 OYN, United Kingdom
The Christie Hospital
RECRUITING

Manchester, M20 4BX, United Kingdom
The Royal Marsden Hospital
RECRUITING

Sutton, SM2 5PT, United Kingdom
University College London Hospital
RECRUITING

London, NW1 2BU, United Kingdom
University Hospital Birmingham
RECRUITING

Birmingham, B15 2TT, United Kingdom
Velindre Cancer Centre
RECRUITING

Cardiff, CF14 2TL, United Kingdom
Western General Hospital
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Weston Park Hospital
RECRUITING

Sheffield, S10 2SJ, United Kingdom

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