A trial looking at V940 and pembrolizumab for renal cell cancer
Cancer type:
Status:
Phase:
This trial is looking at a drug called V940 in combination with pembrolizumab for renal cell cancer.
It is open to people who have had surgery to remove their cancer and have not had any other treatment after their operation.
More about this trial
After your surgery to remove the renal cell cancer, your doctor might treat you with pembrolizumab. The aim of this treatment is to reduce the risk of the cancer coming back. Research has shown that it is a useful treatment for people in this situation. Doctors are looking for ways to further improve treatment.
Pembrolizumab is an immunotherapy. It works by helping the to find and kill cancer cells.
V940 is an immunotherapy. It is a therapy that is made in the laboratory from found in the cells of your cancer. V940 works by helping the immune system to find and kill cancer cells.
Researchers think that combining V940 with pembrolizumab might work better than pembrolizumab on its own. In this trial half the people will have pembrolizumab and V940. And the other half will have pembrolizumab and a dummy drug ().
The aims of the trial are to find out:
- how well the combination of pembrolizumab and V940 works and if it is better than pembrolizumab by itself
- how safe the combination of pembrolizumab and V940 is
- more about the side effects of this combination
- how the combination of pembrolizumab and V940 affects
quality of life
Who can enter
The following bullet points are a summary of the 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.
Who can take part
You may be able to join this trial if all of the following apply. You:
- had kidney cancer that was a clear cell or papillary renal cell cancer and was completely removed by surgery and has a high risk of coming back
- had cancer that was 7cm across and completely in the kidney or had grown into the surrounding tissue or had spread beyond the layer of tissue around the kidney (stage T2, T3 or T4). And your cancer is
high grade (grade 3 or 4). You can join if you had kidney cancer that was stage T1 to T4 if the cancer had spread to 1 or more of the
lymph nodes around the kidney (N1). You might be able to join if your kidney cancer had spread to another part of the body if it was removed when you had surgery to remove your kidney cancer, or it was removed within 2 years of having your kidney cancer removed.
- had surgery to remove your kidney cancer, cancer spread or both within 12 weeks before going into a trial treatment group (
randomisation )
- have had scans and tests that show there is no sign of cancer within a certain period of time before randomisation. Your doctor will know about this.
- have tissue left over from your surgery that the trial team can ask for a piece of and it is suitable for them to use. Your doctor will know this.
- are willing to use reliable contraception during treatment and for a period of time after treatment if there is any chance you or your partner could become pregnant
- have satisfactory blood test results
- are able to look after yourself, are up for most of the day but might not be able to do heavy physical work (performance status 0 or 1)
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- had treatment that reached the whole body (systemic treatment), such as chemotherapy, or you had radiotherapy after your surgery
- had a blood clot in the major vein of the kidney or the
vena cava after your surgery
- had an experimental drug to treat cancer that reaches the whole body within 4 weeks of randomisation
- have had a
cancer vaccine before
- have radiotherapy within 2 weeks of starting the trial treatment. For radiotherapy to relieve symptoms it is 1 week. This is apart from radiotherapy to relieve brain or spinal cord symptoms.
- are taking
steroids to treat ongoing side effects of radiotherapy
- had another cancer that got worse or needed treatment in the past 3 years. This is apart from successfully treated
non melanoma skin cancer and
carcinoma in situ , unless it was carcinoma in situ of the bladder. You can join if you had low risk early stage prostate cancer that was treated with the aim to cure or is untreated and you are in active surveillance and your cancer is stable.
- have, or had, cancer that had spread to the brain or bones
Medical conditions
You cannot join this trial if any of these apply. You:
- have major surgery within 4 weeks of
randomisation . You might be able to join if your surgery was to remove the kidney or an area of cancer spread. Ask your doctor if this is the case.
- have ongoing complications from surgery or have not satisfactorily recovered from surgery
- have had treatment with certain
targeted drugs and
immunotherapy drugs. Your doctor will know which drugs these are.
- are taking an experimental drug or using a device as part of another clinical trial within 4 weeks of starting the trial treatment
- have an immune system that is not working well
- are taking medication such as steroids that damp down the
immune system within 7 days of starting the trial treatment. You might be able to join if you are taking a small dose of steroids. Ask your doctor about this.
- had an
autoimmune disease in the past 2 years that needed treatment. This is apart from certain ones which your doctor will know.
- have hepatitis B unless you are on antiviral medication for at least 4 weeks and your viral load is undetectable before randomisation
- have hepatitis C unless your viral load is undetectable when you join the trial and you have had at least 4 weeks of antiviral medication before randomisation
- have HIV unless you are taking antiretroviral (ART) and it is controlling the HIV
- have an active infection that needs treatment with medication that reaches the whole body such as
antibiotics - have, or had, inflammation of the lungs not caused by an infection that needed treatment with steroids
- have had an
organ transplant - have had a stem cell or bone marrow transplant from a donor (
allogenic transplant )
- have any other medical condition, mental health condition or other circumstances that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to any of the treatments or their ingredients used in this trial
- have had a
live vaccine within 30 days of starting the trial treatment. The COVID-19 and seasonal flu vaccines are not live vaccines.
- are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The team need 272 people worldwide to take part including 15 people in the UK.
This is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which group you are in. This is called a double blind trial.
Your doctor will be able to find out which treatment group you are in if needed.
The 2 groups are:
- V940 and pembrolizumab
- pembrolizumab and a dummy drug (
placebo )
V940
You have V940 as an injection into a muscle, such as the upper arm, thigh or buttocks. You have V940 every 3 weeks. Each 3 week period is a .
V940 is made in the laboratory using genes taken from your cancer cells. Your V940 is made just for you. In the laboratory certain genes with changes () are selected to make V940. To get the genes from the cancer cells, the researchers use a piece of the cancer tissue that was removed when you had surgery. They will also use a sample of your blood. They will make it as fast as possible. But it might take between 6 and 8 weeks from when you join the trial.
It may not be possible to make V940 for some people who take part. In this situation, you will stay in the trial and have pembrolizumab and the dummy drug.
Dummy drug (placebo)
You have the dummy drug as an injection in the same way you have V940.
Pembrolizumab
You have pembrolizumab as a drip into a vein. You have it every 6 weeks. Each 6 weeks is a cycle of treatment.
You can have 9 cycles of the trial treatment as long as it is helping and the side effects aren’t too bad.
Quality of life
People in both groups fill in questionnaires:
- before starting treatment
- during treatment
- after treatment
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- side effects
These are called quality of life questionnaires.
Samples for research
The team ask everyone for a piece of tissue from the cancer that was removed when you had your operation. You also have a blood test. They use these samples to look for substances () that might tell them:
- more about the cancer
- how well treatments work
- why some treatments work better than others
- why some treatments work better for some people
The team will ask for a fresh sample of tissue () if your cancer comes back during the trial. You do not have to agree to have this biopsy taken. You can still take part in the trial.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- CT scan or MRI scan. Your doctor will tell you which scan you have.
- bone scan
- heart trace (ECG)
You see the doctor regularly during treatment. This is to see how you are and for blood tests.
Follow up
Everyone sees the doctor a month after finishing treatment. This is to see how you are.
If you completed treatment, you see the doctor every:
- 12 weeks for a year
- every 16 weeks for year 3 to 5
- every 24 weeks in year 6 and beyond
If you stopped treatment because your cancer came back, the team will contact you every 12 weeks for up to 6 years.
Side effects
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.
Pembrolizumab 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. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
V940 is a new drug and there may be side effects we don’t know about yet.
The side effects of V940 we know about are:
- pain, redness, itching, warmth and swelling at the site of the injection
- high temperature (fever)
- tiredness (fatigue)
- shivering
- flu-like symptoms
- headache
- muscle and joint pain
- feeling sick
- loss of appetite
- diarrhoea
- itching
- inflammation of the bowels
- swelling including legs and joints
- dry mouth
- being more sensitive to sunlight
You might have an allergic reaction to V940. Symptoms include:
- changes in blood pressure
- difficulty breathing
- hives
The healthcare team will watch you closely when you have V940 and for a while after, to make sure you are okay. If you have an allergic reaction, they will give you medication to help.
We have information about pembrolizumab and its side effects.
Your doctor will talk to you about the possible side effects of the treatments used in the trial and will answer any questions you may have.
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 Bala Venugopal
Supported by
Merck Sharpe and Dohme (MSD)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040