A clinical trial, supported by Cancer Research UK, will take place to look at how a drug called nivolumab could help and treat people suffering with mesothelioma, an incurable cancer of the lung.
One of the few treatments for mesothelioma is chemotherapy. After a completed course of chemotherapy, if the mesothelioma relapses, the current aim is to control the symptoms. This is called “active symptom control”.
Researchers conducting this trial want to find out if nivolumab can help these people and if the drug is more effective than active symptom control.
What is nivolumab?
Nivolumab is a type of immunotherapy drug called a monoclonal antibody. It works by stimulating the body’s immune system to recognise and kill cancer cells.
Results from previous research shows that nivolumab could help people whose mesothelioma has returned after chemotherapy, but it isn’t known if it is effective as active symptom control.
What are the aims of the clinical trial?
The main aims of the trial are to find:
- How well nivolumab works for people whose mesothelioma has relapsed;
- How safe it is;
- How it affects quality of life.
What is the design of the trial?
Participants will be put into one of two groups. Neither participants nor their doctors can choose which group they are in and neither will know which group they are in once placed. This is called a “double blind trial”. The groups will consist of:
- Participants taking nivolumab;
- Participants taking a dummy drug (placebo).
The group who will be taking nivolumab will consist of two thirds of participants, and the remaining third will be taking a placebo.
Nivolumab, or the placebo, will be taken as a drip into a vein every two weeks. Treatment will continue for up to a year, unless side effects become too serious or the mesothelioma comes back.
Before the trial begins, when participants agree to take part, they will fill in a questionnaire regarding their quality of life. This will be repeated at the start of the treatment, and again at six weeks and twelve weeks. Then, when the treatment finishes, participants will fill the in the questionnaire again after one month, six months and one year. The questions will ask about how they feel and any side effects they might have.
Will there be any hospital visits?
Before taking part in the trial, participants will see a doctor to have some tests. These include:
- A physical examination;
- Blood tests;
- A CT scan.
During the treatment, participants will see the doctor every two weeks for a physical examination and blood tests and a CT scan will be taken at six weeks and twelve weeks.
What will be the outcome?
It is hoped that if nivolumab can help those in the trial, then it can be widely used by those suffering with mesothelioma.
As it stands, mesothelioma is typically fatal within one year of diagnosis, but research into potential treatments is slowly improving. If successful in the trials, nivolumab could help further our understanding of how to treat and control mesothelioma and what to look for in the future of mesothelioma research.