DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2029

Conditions
Haematological MalignancyMelanomaThyroid Cancer, PapillaryOvarian NeoplasmsColorectal NeoplasmsLaryngeal NeoplasmsCarcinoma, Non-Small-Cell LungGliomaMultiple MyelomaErdheim-Chester DiseaseThyroid Carcinoma, AnaplasticSolid Tumour
Interventions
DRUG

Vemurafenib

Patients will receive vemurafenib at a dose of 960 mg orally (4 tablets of 240 mg) on a twice daily schedule throughout a 28-day cycle. Patients may continue until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent.

DRUG

Cobimetinib

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 until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent.

Trial Locations (15)

B15 2TT

RECRUITING

University Hospital Birmingham, Birmingham

BS2 8ED

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

CB2 OQQ

RECRUITING

Addenbrooke's Hospital, Cambridge

CF14 2TL

RECRUITING

Velindre Cancer Centre, Cardiff

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh

G12 OYN

RECRUITING

The Beatson Hospital, Glasgow

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester

NW1 2BU

RECRUITING

University College London Hospital, London

SE1 9RT

RECRUITING

Guy's Hospital, London

M20 4BX

RECRUITING

The Christie Hospital, Manchester

CH63 4JY

RECRUITING

Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

NE7 7DN

RECRUITING

Freeman Hospital, Newcastle

OX3 7LE

RECRUITING

Churchill Hospital, Oxford

S10 2SJ

RECRUITING

Weston Park Hospital, Sheffield

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

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

lead

Cancer Research UK

OTHER