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

Status:

Results

Phase:

Phase 1/2

This trial looked at nivolumab on its own or with another drug called ipilimumab. It was for people with cancer that had spread:

  • into surrounding tissues or 
  • to another part of their body

This trial was open for people to join between 2013 and 2015. These results were published in 2016.

More about this trial

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

At the time this trial was done doctors already used ipilimumab to treat some people with melanoma skin cancer. Nivolumab was a treatment for different types of cancer.

The aims of this trial were to find out:

  • whether nivolumab and ipilimumab together worked better than nivolumab on its own
  • what the side effects were
  • how safe the treatment was

Summary of results

The trial team found that nivolumab on its own and in combination with ipilimumab worked well for people with small cell lung cancer (SCLC).

Nivolumab on its own worked well for people with a cancer of the urinary tract that had spread. The urinary tract consists of the:

  • centre of the kidney (renal pelvis)
  • tube that take the urine from the kidneys to the bladder (ureter)
  • bladder

Nivolumab on its own and in combination with ipilimumab worked well for people with gastro oesophageal cancer. This included:

  • stomach cancer
  • cancer of the food pipe (oesophagus)
  • cancer where the food pipe joins the stomach (gastro oesophageal junction)

They said there should be further trials of nivolumab in these cancer types. 

About this trial
This was a phase 1/2 trial. 

Results for Small Cell Lung Cancer (SCLC)

216 people with SCLC took part. 

At the start of the trial 3 people had a low dose of nivolumab with a low dose of ipilimumab. This was to make sure the combination of nivolumab and ipilimumab was acceptable and safe for people with SCLC. 

The results provided here are for the other 213 people who were in 3 groups.

  • 98 people had nivolumab on its own.
  • 61 people had a low dose of nivolumab and a higher dose ipilimumab.
  • 54 people had a higher dose of nivolumab and low dose of ipilimumab. 

Everyone was followed up for at least 12 weeks. 

The team looked at how well the treatment worked for people in each group. This included people where there was no sign of their cancer (a complete response) and people whose cancer had shrunk (a partial response). 

They found it was:

  • 10 people (10%) who had nivolumab on its own
  • 14 people (23%) who had low dose nivolumab and high dose ipilimumab
  • 10 (19%) people who had high dose nivolumab and high dose ipilimumab

Across all 3 groups the time it took for treatment to work was from just under 2 months (1.4 months) to just over 2 months (2.1 months). 

The team looked at the overall median  Open a glossary itemtime people lived. They found it was:

  • just under 4½ months (4.4) for people who had nivolumab on its own
  • just over 7½ months (7.7) for people who had low dose nivolumab and high dose ipilimumab
  • 6 months for people who had high dose nivolumab and low dose ipilimumab

The team also looked at the median time people lived before their cancer started to get worse. They found it was:

  • just 1½ months (1.4) for people who had nivolumab on its own
  • just over 2½  months (2.6) for those who had low dose nivolumab and high dose ipilimumab 
  • just under 1½ months for people who had high dose nivolumab and high dose ipilimumab 

Side effects
The team looked at the number of people in each group who had bad to severe side effects. They found it was:

  • 13 people (13%) who had nivolumab on its own
  • 18 people (30%) who had low dose nivolumab and high dose ipilimumab
  • 10 people (19%) who had high dose nivolumab and high dose ipilimumab 


The most common side effects reported were:

  • tiredness (fatigue)
  • itching 
  • diarrhoea
  • feeling sick
  • loss of appetite 
  • changes to how well the thyroid gland Open a glossary item worked 
  • rash

Conclusion for small cell lung cancer                
The team concluded that nivolumab on its own and nivolumab with ipilimumab worked well and the side effects were manageable. 

They say these results suggest that this could be another choice of treatment for people with few options. And to further look at these treatments in a randomised phase 3 clinical trial. 

Results for urinary tract cancer

86 people agreed to take part in the nivolumab on its own part of the trial. 78 people had at least 1 dose of nivolumab. 

These 78 people were followed up for at least 9 months. 

The team looked at how well the treatment worked. They found that for:

  • 5 people there was no sign of their cancer (a complete response)
  • 14 people their cancer had shrunk (a partial response)


The median Open a glossary item length of time it took for treatment to work was 1½ months. 

The median length of time people lived was just over 9½ months (9.7). 

The median length of time people lived without a sign of their cancer getting worse was just over 2½ months (2.8).  

Side effects
Of the 78 people, 17 (22%) had bad to severe side effects. 

The side effects included:

  • tiredness (fatigue)
  • itching
  • rash
  • feeling sick 
  • joint pain
  • a drop in red blood cells (anaemia Open a glossary item) causing breathlessness

Conclusion for urinary tract cancer    
The trial team concluded that nivolumab:

  • worked well
  • was acceptable 

And these results support further research of nivolumab as a treatment for these people. 

Results for gastro oesophageal cancer

160 people with gastro oesophageal cancer took part. This was open to people who had already had chemotherapy but it had stopped working.

  • 59 people had nivolumab on its own.
  • 49 people had a low dose of nivolumab and a high dose of ipilimumab. 
  • 52 people had a high dose of nivolumab and a low dose of ipilimumab.

The median Open a glossary item follow up for each group was about 2 years. 

After a year the trial team looked at the number of people who were still alive and their cancer had not got any worse. They found it was:

  • 5 people (8%) who had nivolumab on its own 
  • 8 people (17%) who had a low dose of nivolumab and a high dose of ipilimumab
  • 5 people (10%) who had a high dose of nivolumab and a low dose of ipilimumab


They also looked at the number of people who were still alive. They found it was:

  • 23 people (39%) who had nivolumab on its own
  • 17 people (35%) who had a low dose of nivolumab and a high dose of ipilimumab
  • 12 people (24%) who had a high dose of nivolumab and a low dose of ipilimumab 

Side effects
The team looked at how many people in each group had severe to very severe side effects. They found that it was:

  • 10 people (17%) in the nivolumab on its own group
  • 23 people (49%) in the low dose of nivolumab and high dose of ipilimumab group
  • 14 people (27%) in the high dose of nivolumab and low dose of ipilimumab group

Conclusions for gastro oesophageal cancer   
The trial team concluded that for these people nivolumab on its own and in combination with ipilimumab:

  • worked when their initial chemotherapy had stopped working and
  • the side effects were manageable

There is now a phase 3 trial going on to look at these treatments for people with gastro oesophageal cancers. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11750

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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