A trial looking at nivolumab for mesothelioma (CONFIRM)

Cancer type:

Mesothelioma

Status:

Results

Phase:

Phase 3

This trial looked at nivolumab to treat mesothelioma that had come back after chemotherapy treatment (relapsed). It was supported by Cancer Research UK.

The trial was open for people to join between 2017 and 2020. The team published the results in 2021.

More about this trial

Mesothelioma is a cancer that most commonly starts in the layers of tissue that cover each lung. This is called the pleura. Rarely it starts in the layer of tissue in the abdomen which surrounds the digestive system organs. This is called the peritoneum. People with either pleural or peritoneal mesothelioma could join this trial.

Doctors usually treat mesothelioma with chemotherapy. But sometimes it starts to grow again.

Nivolumab (Opdivo) is a type of targeted cancer treatment called a monoclonal antibody. It works by stimulating the body’s immune system to recognise and kill cancer cells.

Doctors wanted to find out how well nivolumab works for people who’ve had chemotherapy but their mesothelioma has come back.

In this trial, some people had nivolumab and some had a dummy drug (placebo).

The main aims of the trial were to find:

how well nivolumab works for people whose mesothelioma has come back after chemotherapy
more about the side effects

Summary of results

The trial team found that nivolumab could be a useful treatment for mesothelioma that has come back after chemotherapy.

Trial design
Everyone who took part in this trial had already had at least 1 course of chemotherapy for their mesothelioma. But it had come back or started to grow again.

People taking part were put into a treatment group at random. Two out of every 3 people were in the nivolumab group. And one out of every 3 were in the dummy drug (placebo) group.

They had treatment once every 2 weeks for up to a year.

Results
A total of 332 people took part in this trial. They were put into a treatment group at random:

221 had nivolumab
111 had a dummy drug (placebo)

CONFIRM Diagram 1

The trial team looked at how long it was until people’s cancer started to grow, and found it was:

3 months for those who had nivolumab
1.8 months for those who had the placebo

CONFIRM Bar Chart 1

The team also looked at how long people lived for and found it was:

10.2 months for those who had nivolumab
6.9 months for those who had the placebo

CONFIRM bar chart results

These are early results and the team will continue to see how well people do and analyse the results.

Side effects
No one who had nivolumab had any new or unexpected side effects. Just over 7 out of 10 people (73%) had at least 1 side effect. But some were mild or didn’t last long.

Just under 2 out of 10 people (19%) had a more severe side effect. The most common of these were:

symptoms such as itching, rash or fever just after having treatment (an infusion reaction)
diarrhoea

A little over 1 out of 10 people (13%) who had nivolumab decided to stop treatment early because of the side effects they were having.

We have more information about the side effects of nivolumab in our Cancer drugs section.

Conclusion
The trial team concluded that nivolumab helped stopped mesothelioma growing, and helped people live longer. They suggest it should be a treatment option for people whose mesothelioma has come back after chemotherapy.

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 research team. We have not analysed the data ourselves.