This is a
phase 3 trial. The researchers hope 939 people will take part worldwide including 12 from the UK. It is a
randomised trial. You are put into 1 of the following treatment groups by computer:
- nivolumab and ipilimumab
- nivolumab and chemotherapy
- chemotherapy

You have all your treatment as a
drip into a vein. Depending on which group you are in, you have treatment for up to 2 years. You have it for as long as it is working and the side effects aren’t too bad.
Nivolumab and ipilimumab group
You have treatment in
cycles. Each 2 week period is a cycle of treatment. You have:
- nivolumab every 2 weeks
- ipilimumab every 6 weeks
Nivolumab and chemotherapy group
Each 4 week period is a cycle of treatment. Day 1 is the first day of each treatment cycle. You have:
- nivolumab on day 1 and day 15
- fluorouracil on day 1 to 5 through a small hand held pump
- cisplatin on day 1
Chemotherapy group
Each 4 week period is a cycle of treatment. You have:
- fluorouracil from day 1 to day 5 through a small hand held pump
- cisplatin on day 1
Quality of life
The trial team will ask you to fill out questionnaires before you start treatment and at set times during treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
The trial team will ask you to give some extra blood samples. Where possible you have these at the same time as your routine samples.
They will ask to look at a sample of tissue you gave when you were first diagnosed.
The researchers plan to look at:
- biomarkers
- what happens to the drugs in your body
- genes
They might also ask you to give a new sample if your cancer gets worse. But you don’t have to agree to give this if you don’t want to. You can still take part in the trial.