A trial of targeted treatment for rare cancers that have spread (DETERMINE)
Cancer type:
Status:
Phase:
This trial is looking at matching targeted treatment to people who have a rare cancer. It is also looking at matching targeted treatment to people with a common cancer that has a rare gene change (
) in the cancer cells.
This trial is for people whose cancer has come back or got worse despite treatment. It is also for people when there is no available for them.
The trial is for adults, teenagers and children. We use the term ‘you’, but of course if you are a parent, we are referring to your child.
Cancer Research UK supports this trial.
More about this trial
Researchers are looking for ways to improve treatment for people with a rare cancer that has grown into surrounding tissues or spread elsewhere in the body. Rare cancers affect a small number of people.
In this trial researchers are looking at existing that are already approved treatments for some types of cancer. Researchers want to see how well certain targeted drugs work for other types of cancer.
Targeted cancer drugs work by targeting the differences that help a cancer cell to grow and divide.
To begin with, researchers analyse the cancer cells to check for gene changes. This helps them to work out if one of the drugs in this trial is likely to work for you. They can then match you to a suitable treatment. At the moment, there are 5 treatment groups in the trial.
You will have one of the following treatments:
- alectinib
- atezolizumab
- entrectinib
- trastuzumab and pertuzumab
- vemurafenib and cobimetinib
The main aims of the trial are to:
- find out how well these treatments work for your cancer
- find out how safe these treatments are
- find out what the side effects are
- look for
biomarkers to find out who benefits most from treatment in the future - find out how treatment affects quality of life
Who can enter
The following bullet points are a summary of the main entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Please note, there are several treatment groups so the entry conditions for this trial are complex. Each group has specific entry conditions and we haven’t listed them all.
The group you join depends on the gene changes in your cancer cells.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have cancer that has grown into surrounding tissue or spread elsewhere in the body
- have cancer that has come back after treatment, your treatment has stopped working or there is no standard treatment available
- have a rare cancer that has certain gene changes (
mutations ) in the cancer cells or a common cancer that has a rare mutation in the cancer cells. Your doctor will check this before you join this trial. - have cancer that your doctor can measure or assess to see how treatment is working
- are willing to give a new sample of tissue for the trial team to do some tests on. Some people won’t need to give a new sample. Your doctor can tell you more about this.
- are well enough to have the treatments in the trial
- are willing to use reliable contraception if you are sexually active and there is any chance you or your partner could become pregnant
- are an adult, teenager or a child
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the brain or spinal cord (unless it isn’t causing symptoms, has been treated and is stable)
- are having another cancer treatment
- have had radiotherapy, chemotherapy,
hormone therapy , a nitrosoureas mitomycin C, immunotherapy , targeted drugs or an experimental treatment within 4 weeks of starting trial treatment or it hasn’t cleared your system yet - aren’t well enough to have the treatment in this trial
- have moderate to bad side effects from your previous cancer treatment that aren’t getting better. You might be able to join if your doctor thinks these side effects won’t affect you taking part.
- have an active infection that isn’t well controlled with medication
- have any other medical condition such as
heart problems that the trial doctors think would affect you taking part - have had or might need a
live vaccinaton around starting, during or finishing treatment. The exact timeframes will depend on which treatment you are having. Your doctor can discuss this with you. - are having an experimental treatment as part of a clinical trial
- are pregnant or breastfeeding or planning to become pregnant
| As well as the above there are specific entry conditions and exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial. |
Trial design
This is a phase 2/3 trial. The trial team hope to find at least 30 people to take part in each group.
Trial treatment
The treatment you have depends on the gene changes in your cancer cells. Your doctor analyses a sample of cancer tissue to find this out. Using this information will help them to decide which treatment is best for you. They can tell you more about this.
At the moment, there are 5 treatment groups in the trial. We have included a brief summary of each group.
The trial team plan to add more treatment groups in the future. We’ll update the summary when this happens.
Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Alectinib group
Alectinib is a targeted drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Alectinib is a capsule. You take the capsules twice a day, every day. The team tell you how many capsules to take.
Atezolizumab group
Atezolizumab is a type of targeted cancer drug called an immunotherapy. It helps your to find and kill cancer cells.
You have atezolizumab as a drip into a vein. You have it once every 3 weeks.
Entrectinib group
Entrectinib is a targeted drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Entrectinib is a capsule. You take the capsules once a day, every day.
Trastuzumab and pertuzumab
Trastuzumab and pertuzumab are types of targeted cancer drugs called . They stop signals that cancer cells use to divide and grow.
You have trastuzumab and pertuzumab as a drip into a vein. You have it once every 3 weeks.
Vemurafenib and cobimetinib
Vemurafenib and cobimetinib are types of targeted cancer drugs called cancer growth blockers. They stop signals that cancer cells use to divide and grow.
Vemurafenib and cobimetinib are tablets. You take:
- vemurafenib twice a day, every day for 4 weeks and
- cobimetinib once a day every day for 3 weeks. And then you don’t take it for a week.
For all groups
You have treatment in cycles. You continue to have treatment for as long as it is working and the side effects aren’t too bad.
Hospital visits
You see the doctor and have tests before you can take part. These include:
You might also have:
- x-rays
- eye tests
- bone scan
- heart scan (echocardiogram)
- PET-CT scan
You see the doctor often while having treatment. This is to see how you are and for blood tests. Some of the hospital visits are long. The team can tell you roughly how long you can expect to be at the hospital for.
Those having atezolizumab or trastuzumab and pertuzumab have it on the day care ward. You shouldn’t need to stay overnight.
During treatment you have a CT scan or MRI scan every 6 to 8 weeks. This depends on which treatment group you are in. You might have a PET-CT scan instead. The scan you have depends on the type of cancer you have.
After treatment finishes you see the doctor at 1 month. You then see them every 3 months for 2 years. Or they might call you to see how you are getting on.
Blood and tissue samples for research
The researchers ask you to give an extra tissue sample ( when you join the trial and before you start treatment. They might also ask you to give one when you finish treatment. You can say no to giving this sample.
They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about your cancer type - look for substances called
biomarkers to help work out why treatment might work for some people and not for others.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
|
Atezolizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of atezolizumab are:
- joint pain and back pain, muscle aches or tenderness
- tiredness (fatigue)
- high temperatures (fever)
- headache
- loss of appetite
- feeling or being sick
- diarrhoea
- skin rash and itching
- shortness of breath or a cough
- urine infections
The most common side effects of alectinib include:
- changes to blood tests that show how the liver and muscles work
- a drop in red blood cells (
anaemia ) causing an increased risk of tiredness and breathlessness - constipation or diarrhoea
- feeling or being sick
- skin rash
- swelling caused by fluid build up
- weight gain
The most common side effects of entrectinib include:
- shortness of breath or a cough
- swollen ankles and legs
- confusion, changes in your mood, problems with memory or seeing things that are not there (hallucinations)
- dizziness or feeling lightheaded
- blurred vision
- changes to your heartbeat
- joint or bone pain, muscle aches and pain or problems moving about
- tiredness
- tummy pain, feeling and being sick
- constipation or diarrhoea
- taste changes or loss of appetite
- high temperatures (fever)
- headaches
- weight gain
- changes to the sense of touch. This feels like tingling, itching or a burning sensation.
- skin rash
- problems passing urine or pain when you pass urine
- difficulty swallowing
- sleep problems
The most common side effects of vemurafenib and cobimetinib include:
- sensitivity to sun
- skin lesions or growths
- problems with your eyes. You might have blurred vision, loss of sight, distortion or spots in your vision.
- bleeding problems
- changes to your heartbeat or heart rhythm
- diarrhoea
- feeling or being sick
- high temperatures (fever) or chills
The most common side effects of trastuzumab and pertuzumab include:
- infections or colds
- a drop in blood cells causing an increased risk of breathlessness and tiredness or an increased risk of infection or bleeding
- loss of appetite or weight loss
- difficulty sleeping
- tremor, dizziness, headache or pins and needles
- conjunctivitis and watering eyes
- heart problems
- low or high blood pressure
- hot flushes, difficulty breathing, cough and a runny nose
- diarrhoea or constipation
- feeling or being sick
- tummy pain or indigestion
- sore mouth or lip swelling
- skin rash, dry itchy skin or nail problems
- hair loss
- redness, swelling and pain on the palms of your hands
- joint pain or muscle pain and tightness
- feeling weak
- flu-like symptoms
- fluid build up in the body
- an
allergic reaction to the infusion
Your doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask them any questions you may have.
We have more information about:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Matthew Krebs
Supported by
Cancer Research UK (Centre for Drug Development)
University of Manchester
The Royal Marsden NHS Foundation Trust
University of Birmingham
Roche
Other information
You can find out more about this trial on the DETERMINE website.
This is Cancer Research UK trial number CRUKD/21/004.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
