Actively Recruiting
DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
16
Research Sites
343 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is looking at a combination of drugs called vemurafenib and cobimetinib. Vemurafenib is approved as standard of care for adult patients with unresectable or metastatic melanoma. Cobimetinib is approved as standard of care in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Cobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
CONDITIONS
Official Title
DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cancer with an actionable BRAF V600 mutation using validated next-generation sequencing
- Adult patients 18 years old or older
- Ability and willingness to undergo fresh tissue biopsy and blood sample collection for research
- Adequate organ function based on blood tests as defined in the protocol
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstinence during and for 6 months after treatment
- Male patients with partners of childbearing potential must agree to use barrier contraception or abstinence during and for 6 months after treatment and refrain from sperm donation
You will not qualify if you...
- Diagnosis of unresectable or metastatic melanoma with BRAF V600 mutation
- Female patients who are pregnant, breastfeeding, or planning pregnancy during or for 6 months after treatment
- QTcF interval above 450 ms for males or 470 ms for females on ECG
- History of long QT syndrome, Torsades de Pointes, or medications that increase this risk
- Known allergy to vemurafenib, cobimetinib, or their ingredients
- Inability to swallow tablets whole without chewing or crushing
- Recent live attenuated vaccine within 28 days before or planned during treatment and for 6 months after
- Significant heart conditions within 3 months before screening including uncontrolled angina, arrhythmias, severe heart failure, low heart function, or recent heart attack
- Certain eye disorders like retinal detachment or severe visual impairment
- History of pancreatitis
- Recent central nervous system or gastrointestinal bleeding within 3 months
- History of hemorrhagic stroke
- Prior treatment with the same drug class unless resistance mutations sensitive to study drugs are present
- Any significant illness or condition that could interfere with treatment or pose high risk
- Active infections that affect safety or efficacy assessment, including untreated HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
4
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Actively Recruiting
5
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
6
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
7
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
8
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
9
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
10
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
11
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
12
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
13
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
14
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
15
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
16
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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