Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of talimogene laherparepvec and pembrolizumab for head and neck cancers
This trial is for people with a head and neck cancer that has come back after treatment (recurred) or has spread to another part of the body (metastatic).
Talimogene laherparepvec is a form of the cold sore virus. It has been changed so it isn’t harmful to normal cells, but destroys cancer cells. The virus is changed by altering the genes that tell it how to behave.
More about this trial
Talimogene laherparepvec (T-VEC) works in several ways it:
- puts the changed virus directly into cancer cells where it can grow and kill them
- tells the cancer cell to make more of a substance called GM-CSF before the virus kills it
- helps the body’s immune system to recognise and attack cancer cells
GM-CSF stands for granulocyte and macrophage colony stimulating factor. It can encourage the immune system to recognise and attack cancer cells. Small amounts of GM-CSF are produced naturally in the body.
T-VEC IS injected directly into the cancer. This is called
Pembrolizumab is a type of biological therapy called a monoclonal antibody. It can seek out cancer cells by looking for particular proteins. We know from research that pembrolizumab can help people with a head and neck cancer.
Researchers think the combination of T-VEC and pembrolizumab might be better than pembrolizumab on its own.
There are 2 parts to this trial.
In the 1st part everyone will have T-VEC and pembrolizumab. The main aim of this part is to find how safe it is for people with a head and neck cancer to have T-VEC and pembrolizumab.
In the 2nd part researchers want to compare:
- T-VEC and pembrolizumab
- pembrolizumab and dummy drug (
The main aim of this part of the trial is to find how well the combination of T-VEC and pembrolizumab works for people with a head and neck cancer.
Who can enter
The following bullet points list 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.
You may be able to join this trial if you have one of the following cancers:
And all of the following apply:
- Your cancer is a type called
squamous cell cancer
- Your cancer has come back after treatment or has spread to another part of the body
- Your cancer got worse after having had chemotherapy that included a
platinum drug, such as cisplatin or carboplatin
- You have a single area of cancer, or a
lymph node, at least 10mm across (diameter) that talimogene laherparepvec can be injected into or you have a number of smaller areas of cancer that can be injected into and the total of the diameters of each area adds up to at least 10mm
- You have an area of cancer that can be measured on a scan and hasn’t been treated with radiotherapy
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 4 months afterwards if there is any chance you or your partner could become pregnant and you are willing to use male or female latex condoms during treatment and for 4 months afterwards to avoid the possibility of passing on talimogene laherparepvec
- You are at least 18 years old
You cannot join this trial if any of these apply:
- You have nasopharyngeal cancer
- You have cancer spread to the brain or spinal cord unless the cancer spread has been treated and is stable, you have no symptoms and haven’t had steroids for at least a week before starting treatment
- Your cancer is near your airway and your doctor feels that the swelling caused by injecting it might block the airway
- You have had 3 or more treatments that reach your whole body (
systemic treatment) to treat your cancer that had come back or spread to another part of your body.(This only applies to the phase 3 part of the trial)
- You have had any treatment for cancer in the past 28 days
- You haven’t recovered from any previous treatment for cancer apart from mild to moderate hair loss
- You have had cancer in the past 3 years apart from successfully treated
non melanoma skin cancer, some early cancersand any other cancer that has been treated with the aim to cure, hasn’t been treated with chemotherapy in the past 3 years and there is a low risk of the cancer coming back
- You have had a 2nd course of treatment with radiotherapy
- Your cancer has direct contact with a blood vessel or surrounds a blood vessel and the cancer is visible on your skin or there are ulcers on the skin
- You have symptoms of inflammation of the lung (pneumonitis) or have had steroids to treat pneumonitis
- You have had an
autoimmune diseasethat has needed treatment that reaches your whole body in the past 2 years apart from treatment that replaces a substance in the body for example thyroxine and insulin
- You currently have an outbreak of herpes infection
- You have complications of a previous herpes infection for example inflammation of the eye or inflammation of the brain
- You have a weakened
immune systemdue to another disease such as an infection
- You have HIV, hepatitis B or hepatitis C
- You have had treatment for hepatitis B or hepatitis C within the 12 weeks before starting treatment in this trial
- You have had major surgery in the past 28 days
- You have had an organ transplant
- You have had medication such as steroids that damp down the immune system for more than 2 weeks or within a week of starting treatment in this trial
- You are taking medication by mouth or as an injection such as acyclovir to treat herpes apart from the occasional use of cream
- You have had a
live vaccinewithin a month of agreeing to take part in this trial
- You have already had talimogene laherparepvec
- You have had an experimental drug or used an experimental device as part of another clinical trial in the past 28 days
- You are sensitive to talimogene laherparepvec or any of its ingredients
- You have another medical or mental health problem that the study team think could affect you taking part
- You are pregnant or breastfeeding
The phase 1 part is still open. The phase 3 part will open after the phase 1 part is completed.
In this part the trial team need 40 people to join. Everyone will have talimogene laherparepvec (T-VEC) and pembrolizumab.
In this part the trial team need 450 people to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
The 2 groups are:
- T-VEC with pembrolizumab
- pembrolizumab with placebo
T-VEC is injected directly into the cancer. You may have more than 1 cancer site injected. Your doctor will talk to you about how many will be injected. The doctor might use
You have pembrolizumab as a drip into a vein (intravenous) every 3 weeks.
You continue to have treatment as long as it is helping and the side effects are too bad.
Quality of life
The trial team will ask people in the phase 3 trial to fill out a questionnaire:
- at the start treatment
- every 3 weeks to 18 weeks
- every 9 weeks to the end of treatment
- a month after the end of treatment
- every 3 months during follow up (if applicable)
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Tissue and blood samples
The team will ask for a sample of your cancer that was removed when you had surgery or a
To take part in the trial a sample of tissue from your cancer must have been taken in the past 6 months. You will need to have a new biopsy done if this hasn’t been done.
They will also ask for extra blood samples. They will use these to look for substances in the body (
The team will also ask if you are willing to have your tissue and blood samples stored for future research. You don’t have to agree to this. You can still take part in the trial.
Talimogene laherparepvec is a changed form of the cold sore virus (herpes virus). If you develop a rash or a sore that your doctor thinks might be herpes, they will ask your permission to take a swab of it. This is to find out if they can detect talimogene laherparepvec in the rash or sore. Your doctor will talk to you about this.
You see the doctor to have some tests before you take part. These tests include:
- a physical examination
- blood tests
- urine test
- heart trace (
- a body scan such as an MRI scan or CT scan
During treatment you see the doctor every 3 weeks for a physical examination and blood tests.
A month after finishing treatment you see the doctor for the same tests you had at the beginning.
You then see the doctor every 3 months for 3 years to have:
- a physical examination
- blood tests (only twice)
- scan such as an MRI scan or CT scan (until your cancer starts to grow again)
A member of the team will see you at your clinic appointment or phone you every 3 months. They will ask you a few questions about your health. They might also ask you to let them know when you:
- have been in hospital
- start any new medications
- are ill
The most common side effects of talimogene laherparepvec are:
- flu like symptoms including chills, a high temperature (fever), feeling sick, tiredness and muscle pain
- pain at the injection site
- joint, arm and leg pain
- diarrhoea or constipation
We have information on the side effects of pembrolizumab.
Your doctor will talk to you about the side effects of talimogene laherparepvec and pembrolizumab before you agree to take part.
How to join a clinical trial
Professor Kevin Harrington