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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Aida Sarmiento Castro +442034695101
determine@cancer.org.uk


Study Location:

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

Recruiting

Open to: ALL

Age: All

Manchester London Newcastle Southampton Birmingham Belfast Sheffield Oxford Edinburgh Leicester London London Cardiff Manchester Wirral Bristol Birmingham Cambridge Glasgow Glasgow Liverpool London Borough of Sutton Newcastle Bristol Oxford

Medical Conditions

Neoplasms
Hematologic Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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). Participants 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 Oct 2029

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Treatment Arm 1: Alectinib;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Treatment Arm 2: Atezolizumab;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Treatment Arm 3: Entrectinib;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Treatment Arm 4: Trastuzumab in combination with pertuzumab;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Treatment Arm 5: Vemurafenib in combination with cobimetinib;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Manchester Children's Hospital
    Manchester
    M13 9WL
  • Great Ormond Street Hospital
    London
    WC1N 3JH
  • Freeman Hospital
    Newcastle
    NE7 7DN
  • Southampton General Hospital
    Southampton
    SO16 6YD
  • Birmingham Children's Hospital
    Birmingham
    B4 6NH
  • Belfast City Hospital
    Belfast
    BT9 7AB
  • Weston Park Hospital
    Sheffield
    S10 2SJ
  • John Radcliffe Hospital
    Oxford
    OX3 9DU
  • Western General Hospital
    Edinburgh
    EH4 2XU
  • Leicester Royal Infirmary
    Leicester
    LE1 5WW
  • Guy's Hospital
    London
    SE1 9RT
  • University College London Hospital
    London
    NW1 2BU
  • Velindre Cancer Centre
    Cardiff
    CF14 2TL
  • The Christie Hospital
    Manchester
    M20 4BX
  • Clatterbridge Cancer Centre
    Wirral
    CH63 4JY
  • Bristol Royal Hospital for Children
    Bristol
    BS2 8BJ
  • University Hospital Birmingham
    Birmingham
    B15 2TT
  • Addenbrooke's Hospital
    Cambridge
    CB2 OQQ
  • The Beatson Hospital
    Glasgow
    G12 OYN
  • Royal Hospital for Children Glasgow
    Glasgow
    G51 4TF
  • Alder Hey Hospital
    Liverpool
    L14 5AB
  • The Royal Marsden Hospital
    London Borough of Sutton
    SM2 5PT
  • Great North Children's Hospital
    Newcastle
    NE1 4LP
  • Bristol Haematology and Oncology Centre
    Bristol
    BS2 8ED
  • Churchill Hospital
    Oxford
    OX3 7LE

Aida Sarmiento Castro +442034695101
determine@cancer.org.uk



The study is sponsored by Cancer Research UK and is in collaboration with University of Manchester; University of Birmingham; Royal Marsden NHS Foundation Trust; Hoffmann-La Roche.



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Read full details for Trial ID: NCT05722886
Last updated 19 March 2024

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