A trial of nivolumab and ipilimumab for people with solid tumours that have spread (CA209032)

Cancer type:

Lung cancer
Ovarian cancer
Small cell lung cancer




Phase 1/2

This trial is looking at nivolumab either on its own or alongside a drug called ipilimumab for people with cancer that has spread into surrounding tissues, or to another part of their body.  This trial is now recruiting people with

More about this trial

It is no longer recruiting people with

Recruitment for these cancer types has now closed.

Nivolumab and ipilimumab are both types of biological therapy called monoclonal antibodies. These drugs aim to seek out cancer cells by looking for particular proteins.

Doctors already use ipilimumab to treat some people with melanoma skin cancer. Nivolumab (also known as BMS-936558) is a new drug being tested in trials for different types of cancer.

The aims of this trial are to find out

  • Whether nivolumab and ipilimumab together works better than nivolumab alone
  • What the side effects are
  • How safe the treatment is

Who can enter

You may be able to join this trial if you have one of the following situations.

You have have small cell lung cancer that has continued to grow or come back despite having standard treatment. You must have had at least 1 course of chemotherapy that included a platinum drug Open a glossary item, but no more than 2 courses of chemotherapy.

You have ovarian cancer, fallopian tube cancer or primary peritoneal cancer and your cancer has continued to grow or come back following at least 1 course of chemotherapy that included a platinum drug. You may also have had other treatments, including biological therapy.

As well as the above, all the following must apply. You

  • Have cancer that can be measured by a scan
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for several months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply. You

  • Have cancer that has spread to your brain and hasn’t been treated or is causing symptoms. You can take part if cancer spread to your brain has been treated with surgery or radiotherapy, is not getting worse and if you take steroids, the dose has been the same for at least 2 weeks
  • Have already had treatment with ipilimumab or another drug that works in a similar way to nivolumab (the trial team can advise you about this)
  • Have had chemotherapy, radiotherapy,biological therapy or treatment in a trial in the last 4 weeks, or radiotherapy to treat a single area of cancer spread in the last 2 weeks (there may be some exceptions to this that the trial team can advise you about)
  • Are still having side effects from any anti cancer treatment, apart from hair loss and tiredness (fatigue)
  • Have a condition that affects your immune system (the trial team can advise you about this)
  • Have any other medical condition that the trial doctor thinks could affect your taking part
  • Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are allergic to the drugs used in this trial, anything they contain, or similar drugs
  • Are pregnant or breast feeding

Trial design

This international phase 1/2 trial is recruiting about 160 patients, including about 22 people from the UK. It is a randomised trial. The people taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • People in one group have nivolumab
  • People in the other group have nivolumab and ipilimumab

You have both of these drugs through a drip into a vein. If you are in the group having nivolumab alone, you have it every 2 weeks. It takes about an hour each time.

If you are in the group having nivolumab and ipilimumab, you have nivolumab first followed by ipilimumab. This will take about two and a half hours. You have treatment every 3 weeks for the first 12 weeks. After these 4 treatments, you then have nivolumab alone every 2 weeks.

People in either group can carry on having nivolumab for as long as it is helping and you don’t have bad side effects.

If you have nivolumab alone, and your cancer starts to grow again, you may be able to cross over to the other group and have treatment with both drugs. Your doctor will discuss this with you if it is possible.

The trial team will ask you to fill out a questionnaire before you start treatment, every 2 to 3 weeks during treatment, then 1 month and 3 months after you finish treatment. The questionnaire will ask about side effects and how you've been feeling. This is called a quality of life study.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • CT scan

You may have an MRI scan of your brain.

The trial team will ask to take a biopsy Open a glossary item of your cancer. If this is not possible, they will need to get a sample of your cancer that was removed when you had surgery or a biopsy in the past.

During treatment, you go to hospital every 2 to 3 weeks depending on which treatment group you are in.

Everybody taking part has regular blood tests throughout treatment. You have a CT or MRI scan about 9 weeks after starting treatment, then every 6 weeks for 6 months. These are then reduced to every 3 months for as long as you have treatment.

When you finish treatment you go to hospital after 1 month and 3 months. The trial team will then check how you are every 3 months. This may be at a hospital appointment or by phone. You may have more CT or MRI scans.

Side effects

As nivolumab is a new drug, there may be side effects we don't know about yet. In other trials, the most common side effects have included

The most common side effects of ipilimumab include

  • Diarrhoea and abdominal pain
  • Constipation
  • Tiredness
  • Skin rash or itchy skin
  • Feeling and being sick
  • Loss of appetite
  • High temperature
  • Headache

We have more information about ipilimumab.



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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Jeff Evans

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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