A study of nivolumab before other treatment for cancer (CA209358 Neo adjuvant group)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is to find out what effect giving nivolumab before surgery or chemotherapy and radiotherapy together (chemoradiotherapy) has on certain cancers.
There are 2 groups in this study
- people who are having other anti-cancer treatment (the Neo adjuvant group)
- people whose cancer has spread (the Metastatic group)
This summary is for the Neo adjuvant group. We have information for the Metastatic group.
More about this trial
Nivolumab is a type of biological therapy called a monoclonal antibody. It works by triggering the 
to attack and kill cancer cells.
We know from research that nivolumab works for people who have melanoma that has spread and some types of lung cancer.
In this study researchers want to look at
- merkel cell skin cancer
- cervical cancer
- vulval cancer
- vaginal cancer
- mouth cancer
- laryngeal cancer
- pharyngeal cancer
You have nivolumab before having any other treatment for your cancer.
The main aims of this study are to find
- how well nivolumab works for these cancers
- how safe it is
- how well people cope with the drug
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if you have one of the following
Or a of one of the following
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Nasopharyngeal cancer
- Mouth cancer
- Oropharyngeal cancer
- Laryngeal cancer
And
- Your cancer can be removed by surgery or you are to have
chemoradiotherapy - You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You must be willing to use reliable contraception during treatment and for up to 31 weeks afterwards if there is a chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this study if any of these apply
- You have cancer that has spread to the brain unless it has been treated, an
MRI scan shows it hasn’t got worse in the past 4 weeks and within 28 days of starting treatment in the study and you aren’t taking more than 10 mg of steroids for at least 2 weeks before starting treatment - Your cancer or an affected
lymph node is attached to the main blood vessel in the neck, the part of the spine in the neck or at the base of the skull - You have had any cancer treatment including as part of a clinical trial in the past 4 weeks
- You have been treated with an anti cancer vaccine as part of a clinical trial
- You still have moderate to severe side effects from any treatment, apart from hair loss and tiredness
- You have had another cancer in the past 3 years apart from successfully treated
early cancers - You have an
autoimmune disease apart from conditions that you have hormone replacement for such as vitiligo, diabetes or underactive thyroid or any condition that isn’t expected to come back - You are taking medication that reaches your whole body, such as steroids, that affect how your
immune system works - You have HIV, hepatitis B or hepatitis C
- You are allergic to nivolumab or any of its ingredients
- You have had a severe allergic reaction to any monoclonal antibody
- You are pregnant or breastfeeding
Trial design
This is an international phase 1/2 study. The researchers need 84 people to join the Neo adjuvant group.
You have nivolumab as an injection into a vein. You have it every 2 weeks. You have a total of 2 doses before starting your other treatment.
After having nivolumab some people might have surgery to remove their cancer. The researchers will take a sample of tissue from what was removed.
People who don't have surgery will have a sample of tissue (biopsy) taken of their cancer.
You might be able to start nivolumab again if your cancer spreads and it can’t be removed by surgery.
Quality of life
The researchers will ask you to fill out a questionnaire
- when you have nivolumab
- 1 month after treatment
- 2 months after
- Then every 3 months
The questionnaires will ask about how you have being feeling and any side effects. This is a quality of life study.
Extra blood and tissue samples
The team will ask for extra blood samples. They will use these to look for substances ) in the blood that might tell them how well nivolumab is working.
Another sample of tissue will be asked for if your cancer gets worse or spreads. You don’t have to agree to have this done.
Hospital visits
You see the doctor to have some tests before taking part. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - A
scan such a CT scan or MRI scan
Before having nivolumab you see the doctor for a physical examination and blood tests.
After having nivolumab you see the doctor
- Before you have surgery or a biopsy taken
- 1 month after finishing nivolumab
- 2 months
- 4 months
- 8 months
- 1 year
- Then every 3 months
Side effects
The most common side effects of nivolumab are
- tiredness
- skin reactions such as a rash, itching, hives, redness, and dry skin
- diarrhoea
- feeling sick
- tummy (abdominal) pain
- loss of appetite
- a drop in red blood cells
- high temperature (fever)
- joint pain
We have more information about nivolumab.
Your doctor will talk to you about the side effects before you agree to take part.
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
Professor Jeff Evans
Supported by
Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
