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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

825

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2029

Conditions
Haematological MalignancySolid Tumour
Interventions
DRUG

Alectinib

"Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily.~Paediatric patients 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 patients may continue on treatment until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

DRUG

Atezolizumab

"Adult patients will receive 1200 mg of atezolizumab intravenously every 21 days.~Paediatric patients will receive atezolizumab at a dose of 15 mg/kg (maximum 1200 mg) every 21 days.~Patients may continue on treatment until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

DRUG

Entrectinib

"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).~Paediatric patients with BSA \<1.51 m\^2 will receive a dose adjusted for BSA. Each cycle of treatment will consist of 28 days and patients may continue until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

DRUG

Trastuzumab in combination with pertuzumab

"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.~The initial loading dose of pertuzumab is 840 mg followed thereafter by a maintenance dose of 420 mg administered intravenously every 21 days. Paediatric patients will receive a dose of pertuzumab adjusted by body weight.~Patients may continue until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

DRUG

Vemurafenib in combination with cobimetinib

"Patients 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.~Patients 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.~Patients may continue on treatment until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

DRUG

Capmatinib

Patients will be administered capmatinib orally at a daily dose of 800 mg consisting of 400 mg (two 200 mg tablets) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent.

Trial Locations (27)

BT9 7AB

RECRUITING

Belfast City Hospital, Belfast

B15 2TT

RECRUITING

University Hospital Birmingham, Birmingham

B4 6NH

NOT_YET_RECRUITING

Birmingham Children's Hospital, Birmingham

BS2 8BJ

RECRUITING

Bristol Royal Hospital for Children, Bristol

BS2 8ED

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

CB2 OQQ

RECRUITING

Addenbrooke's Hospital, Cambridge

CF14 2TL

RECRUITING

Velindre Cancer Centre, Cardiff

CF14 4XW

NOT_YET_RECRUITING

Cardiff Children's Hospital, Cardiff

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh

G12 OYN

RECRUITING

The Beatson Hospital, Glasgow

G51 4TF

RECRUITING

Royal Hospital for Children Glasgow, Glasgow

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester

L14 5AB

RECRUITING

Alder Hey Hospital, Liverpool

NW1 2BU

RECRUITING

University College London Hospital, London

SE1 9RT

RECRUITING

Guy's Hospital, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital, London

M13 9WL

NOT_YET_RECRUITING

Royal Manchester Children's Hospital, Manchester

M20 4BX

RECRUITING

The Christie Hospital, Manchester

CH63 4JY

RECRUITING

Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

NE1 4LP

RECRUITING

Great North Children's Hospital, Newcastle

NE7 7DN

RECRUITING

Freeman Hospital, Newcastle

OX3 7LE

RECRUITING

Churchill Hospital, Oxford

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford

S10 2SJ

RECRUITING

Weston Park Hospital, Sheffield

S10 2TH

RECRUITING

Sheffield's Children's Hospital, Sheffield

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton

SM2 5PT

RECRUITING

The Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

University of Manchester

OTHER

collaborator

University of Birmingham

OTHER

collaborator

Royal Marsden NHS Foundation Trust

OTHER

collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Cancer Research UK

OTHER