- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722886
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol (DETERMINE)
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
Study Overview
Status
Conditions
Detailed Description
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 teenagers/young adult 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 where promising activity is identified to a target of 30 evaluable patients each. The total number of patients recruited to the platform will depend on the number of treatment arms and sub-cohorts opened.
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 evaluate the anti-cancer activity of licensed targeted drugs outside their license 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.
- 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 NHS England to provide new treatment options for rare adult, paediatric and TYA cancers.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Aida Sarmiento Castro
- Phone Number: +442034695101
- Email: determine@cancer.org.uk
Study Locations
-
-
-
Belfast, United Kingdom, BT9 7AB
- Recruiting
- Belfast City Hospital
-
Contact:
- Vicky Coyle, Prof
- Email: V.Coyle@qub.ac.uk
-
Principal Investigator:
- Vicky Coyle, Prof
-
Birmingham, United Kingdom, B4 6NH
- Not yet recruiting
- Birmingham Children's Hospital
-
Principal Investigator:
- Susanne Gatz, Dr
-
Contact:
- Susanne Gatz, Dr
- Phone Number: 6266 0121 333 9999
- Email: Susanne.Gatz@nhs.net
-
Birmingham, United Kingdom, B15 2TT
- Recruiting
- University Hospital Birmingham
-
Contact:
- Gary Middleton, Prof
- Phone Number: 0121 371 3573
- Email: G.Middleton@bham.ac.uk
-
Principal Investigator:
- Gary Middleton, Prof
-
Bristol, United Kingdom, BS2 8ED
- Recruiting
- Bristol Haematology and Oncology Centre
-
Contact:
- Antony Ng, Dr
- Phone Number: 0117 342 8044
- Email: Antony.Ng@uhbw.nhs.uk
-
Principal Investigator:
- Antony Ng, Dr
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Bristol, United Kingdom, BS2 8BJ
- Recruiting
- Bristol Royal Hospital for Children
-
Contact:
- Antony Ng, Dr
- Phone Number: 0117 342 8044
- Email: Antony.Ng@uhbw.nhs.uk
-
Principal Investigator:
- Antony Ng, Dr
-
Cambridge, United Kingdom, CB2 OQQ
- Recruiting
- Addenbrooke's Hospital
-
Contact:
- Bristi Basu, Dr
- Phone Number: 01223 596105
- Email: bb313@medschl.cam.ac.uk
-
Principal Investigator:
- Bristi Basu, Dr
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Cardiff, United Kingdom, CF14 2TL
- Recruiting
- Velindre Cancer Centre
-
Contact:
- Robert Jones, Dr
- Phone Number: 6327 02920 615888
- Email: Robert.Hugh.Jones@wales.nhs.uk
-
Principal Investigator:
- Robert Jones, Dr
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Edinburgh, United Kingdom, EH4 2XU
- Recruiting
- Western General Hospital
-
Contact:
- Stefan Symeonides, Dr
-
Principal Investigator:
- Stefan Symeonides, Dr
-
Glasgow, United Kingdom, G12 OYN
- Recruiting
- The Beatson Hospital
-
Contact:
- Patricia Roxburgh, Dr
- Phone Number: 0141 301 7118
- Email: Patricia.Roxburgh@glasgow.ac.uk
-
Principal Investigator:
- Patricia Roxburgh, Dr
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Glasgow, United Kingdom, G51 4TF
- Recruiting
- Royal Hospital for Children Glasgow
-
Contact:
- Milind Ronghe, Dr
- Phone Number: 0141 452 6692
- Email: Milind.Ronghe@ggc.scot.nhs.uk
-
Principal Investigator:
- Milind Ronghe, Dr
-
Leicester, United Kingdom, LE1 5WW
- Recruiting
- Leicester Royal Infirmary
-
Contact:
- Anne Thomas, Dr
- Phone Number: 0116 2587601
- Email: at107@le.ac.uk
-
Principal Investigator:
- Anne Thomas, Dr
-
Liverpool, United Kingdom, L14 5AB
- Recruiting
- Alder Hey Hospital
-
Contact:
- Lisa Howell, Dr
- Phone Number: 0151 293 3679
- Email: Lisa.Howell@alderhey.nhs.uk
-
Principal Investigator:
- Lisa Howell, Dr
-
London, United Kingdom, WC1N 3JH
- Not yet recruiting
- Great Ormond Street Hospital
-
Contact:
- Darren Hargrave, Dr
- Phone Number: 0207 813 8525
- Email: Darren.hargrave@gosh.nhs.uk
-
Principal Investigator:
- Darren Hargrave, Dr
-
London, United Kingdom, NW1 2BU
- Recruiting
- University College London Hospital
-
Contact:
- Martin Foster, Prof
- Phone Number: 020 3447 5085
- Email: M.Forster@ucl.ac.uk
-
Principal Investigator:
- Martin Foster, Prof
-
London, United Kingdom, SE1 9RT
- Recruiting
- Guy's Hospital
-
Principal Investigator:
- James Spicer, Dr
-
Contact:
- James Spicer
- Phone Number: 020 7188 4260
- Email: james.spicer@kcl.ac.uk
-
London Borough of Sutton, United Kingdom, SM2 5PT
- Recruiting
- The Royal Marsden Hospital
-
Contact:
- Lynley Marshall, Dr
- Phone Number: 0208 661 3678
- Email: LynleyVanessa.Marshall@icr.ac.uk
-
Principal Investigator:
- Lynley Marshall, Dr
-
Manchester, United Kingdom, M13 9WL
- Not yet recruiting
- Royal Manchester Children's Hospital
-
Contact:
- Guy Makin, Dr
- Phone Number: 0161 701 8419
- Email: Guy.Makin@mft.nhs.uk
-
Principal Investigator:
- Guy Makin, Dr
-
Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie Hospital
-
Principal Investigator:
- Matthew Krebs
-
Contact:
- Matthew Krebs, Prof
- Phone Number: 0161 918 7672
- Email: Matthew.Krebs@nhs.net
-
Newcastle, United Kingdom, NE7 7DN
- Recruiting
- Freeman Hospital
-
Principal Investigator:
- Alastair Greystoke, Dr
-
Contact:
- Alastair Greystoke, Dr
- Phone Number: 0191 2138476
- Email: Greystoke@newcastle.ac.uk
-
Newcastle, United Kingdom, NE1 4LP
- Recruiting
- Great North Children's Hospital
-
Contact:
- Alastair Greystoke, Dr
- Phone Number: 0191 2138476
- Email: Alastair.Greystoke@newcastle.ac.uk
-
Principal Investigator:
- Alastair Greystoke, Dr
-
Oxford, United Kingdom, OX3 7LE
- Recruiting
- Churchill Hospital
-
Contact:
- Sarah Pratap, Dr
- Phone Number: 01865 235273
- Email: Sarah.Pratap@ouh.nhs.uk
-
Principal Investigator:
- Sarah Pratap, Dr
-
Oxford, United Kingdom, OX3 9DU
- Recruiting
- John Radcliffe Hospital
-
Contact:
- Sarah Pratap, Dr
- Phone Number: 01865 235273
- Email: Sarah.Pratap@ouh.nhs.uk
-
Principal Investigator:
- Sarah Pratap, Dr
-
Sheffield, United Kingdom, S10 2SJ
- Not yet recruiting
- Weston Park Hospital
-
Contact:
- Sarah Danson, Dr
- Phone Number: 0114 226 5068
- Email: s.danson@sheffield.ac.uk
-
Principal Investigator:
- Sarah Danson, Dr
-
Southampton, United Kingdom, SO16 6YD
- Not yet recruiting
- Southampton General Hospital
-
Contact:
- Juliet Gray, Prof
- Phone Number: 0238 120 6639
- Email: Juliet.Gray@uhs.nhs.uk
-
Principal Investigator:
- Juliet Gray, Prof
-
Wirral, United Kingdom, CH63 4JY
- Not yet recruiting
- Clatterbridge Cancer Centre
-
Contact:
- Dan Palmer, Dr
- Phone Number: 0151 706 4172 / 0151 706 4177
- Email: daniel.palmer@liverpool.ac.uk
-
Principal Investigator:
- Dan Palmer, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
THE PARTICIPANT MUST FULFIL THE ELIGIBILITY CRITERIA OUTLINED BELOW AND WITHIN THE SPECIFIC TREATMENT ARM APPENDIX TO WHICH THEY ARE ENROLLED.
Core Inclusion Criteria
Any patient with histologically proven locally advanced or metastatic cancer (solid tumour or haematological malignancy) who has:
- exhausted (or declined) standard-of-care treatment options.
- or for whom no effective standard treatment is available*. *In exceptional circumstances where upfront treatment on the CRUKD/21/004 DETERMINE trial is considered the best choice for the patient in the opinion of the Investigator, due to risk of considerable harm from standard treatment (e.g. where this involves mutilating surgery or is unacceptable due to patient age or genetic vulnerability such as CMMRD).
- and whose disease has progressed, or is refractory.
- Diagnosis of a rare cancer harbouring an actionable genomic alteration, or common cancer types with rare actionable genomic alterations, that have been identified using a validated sequencing technique and for which there is a relevant open treatment arm within the DETERMINE trial.
- Life expectancy of at least three months.
- 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 of age, 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).
- Patients with objectively evaluable or measurable disease, according to an assessment method appropriate for their cancer type.
- Patients must provide a fresh tissue biopsy at baseline and blood samples for translational research.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status 2 may be considered on an individual basis) (≥ 16 years), Karnofsky score ≥ 50% (12 years to 15 years) or Lansky Play scales ≥ 50% (<12 years). Please see specific treatment arm appendices for any variations on this criterion. Note: Patients <16 years: patients with Central Nervous System (CNS) tumours and a 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, be due to tumour or due to a post-surgical adverse event that is deemed by the local Investigator.
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.
- 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:
- Ongoing AEs >Common Terminology Criteria of Adverse Events (CTCAE) Grade 2 attributable to previous anti-cancer treatments. Exceptions to this are any ongoing toxic manifestation, which in the opinion of the Investigator should not exclude the patient.
- At high medical risk, in the opinion of the Investigator, because of non-malignant systemic disease (including active uncontrolled infection).
- 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.
Is (or plans to be) a participant 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 Quality of Life (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).
- Co-administration of anti-cancer therapies other than those administered in this trial.
- Radiotherapy (except for palliative reasons) or chemotherapy, endocrine therapy, nitrosoureas, mitomycin-C, immunotherapy and molecularly targeted agents or other investigational medicinal products within 4 weeks or 5 half-lives (whichever is the shorter).
- 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 two weeks prior to registration. 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 trial enrolment. 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.
- Any other condition which, in the opinion of the local Investigator, would not be in the best interests of the patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm 1: Alectinib
This alectinib treatment arm is for adult, teenage/young adults (TYA) and paediatric participants with ALK-positive cancers.
|
Adult participants will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric participants with a body weight ≥40 kg and who are able to swallow the capsules will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and participants may continue on treatment until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
|
Experimental: Treatment Arm 2: Atezolizumab
This atezolizumab treatment arm is for adult, teenage/young adults (TYA) and paediatric participants with high tumour mutational burden (TMB) or microsatellite instability high (MSI-high) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD) only.
|
Adult participants will receive 1200 mg of atezolizumab intravenously every 21 days. Paediatric participants will receive atezolizumab at a dose of 15 mg/kg (maximum 1200 mg) every 21 days. Participants may continue on treatment until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
|
Experimental: Treatment Arm 3: Entrectinib
This entrectinib treatment arm is for adult, teenage/young adult (TYA) and paediatric participants with ROS1 gene fusion-positive malignancies only.
|
Adult and paediatric participants 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). Paediatric participants will receive a dose adjusted for BSA. Each cycle of treatment will consist of 28 days and participants may continue until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
|
Experimental: Treatment Arm 4: Trastuzumab in combination with pertuzumab
This trastuzumab and pertuzumab treatment arm is for adult, teenage/young adult (TYA) and paediatric participants with malignancies with HER2 amplification or activating mutations.
|
The initial loading dose of trastuzumab is 8 mg/kg body weight administered intravenously every 21 days followed thereafter by a maintenance dose of 6 mg/kg body weight. The initial loading dose of pertuzumab is 840 mg administered intravenously every 21 days followed thereafter by a maintenance dose of 420 mg. Participants may continue until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
|
Experimental: Treatment Arm 5: Vemurafenib in combination with cobimetinib
This vemurafenib and cobimetinib appendix is for BRAF V600 mutation-positive malignancies occurring in adults only.
|
Participants will receive vemurafenib at a dose of 960 mg (4 tablets of 240 mg) orally on a twice daily schedule throughout a 28-day cycle. Participants will receive cobimetinib at a dose of 60 mg (3 tablets of 20 mg) to be taken orally, once daily for 21 consecutive days (days 1 to 21 in each 28-day cycle); followed by a 7-day break. Participants may continue on treatment until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who consent to each arm.
Time Frame: Up to 5 years.
|
This is a master screening entry with sub-study entries to capture the results of each arm.
As such a primary outcome measure for this entry is not relevant, however this entry will be used to report the number of patients with a cancer containing the appropriate genetic alteration that have been successfully allocated and consented to each arm.
|
Up to 5 years.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Krebs, Prof, The Christie Hospital
Publications and helpful links
Helpful Links
- Overview of the DETERMINE trial.
- ClinicalTrials.gov record for DETERMINE Trial Treatment Arm 01 (alectinib) (NCT05770037)
- ClinicalTrials.gov record for DETERMINE Trial Treatment Arm 02 (atezolizumab) (NCT05770102)
- ClinicalTrials.gov record for DETERMINE Trial Treatment Arm 03 (entrectinib) (NCT05770544)
- ClinicalTrials.gov record for DETERMINE Trial Treatment Arm 04 (trastuzumab in combination with pertuzumab) (NCT05786716)
- ClinicalTrials.gov record for DETERMINE Trial Treatment Arm 05 (vemurafenib in combination with cobimetinib) (NCT05768178)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Child
- Cancer
- Rare
- Adult
- Immune Checkpoint Inhibitors
- Atezolizumab
- Antineoplastic Agents
- Mutation
- Trastuzumab
- Young adult
- Precision Medicine
- Malignancy
- Pertuzumab
- Lymphoproliferative Disorders
- Cobimetinib
- Neoplasms by Histologic Type
- Paediatric
- Neoplasms by Site
- Molecular Targeted Therapy
- Vemurafenib
- Genes, HER2
- Protein Kinase Inhibitors
- TMB
- Alectinib
- MSI
- Entrectinib
- Malignant Neoplasms
- Immunological
- ALK Tyrosine Kinase Receptor
- BRAF Kinase
- CMMRD
- ROS1 protein, human
- Tumour-agnostic
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Tyrosine Kinase Inhibitors
- Trastuzumab
- Atezolizumab
- Pertuzumab
- Vemurafenib
- Entrectinib
- Alectinib
Other Study ID Numbers
- CRUKD/21/004
- IRAS ID: 1004057 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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