A trial comparing 2 ways of giving dabrafenib and trametinib for advanced melanoma (INTERIM)
Cancer type:
Status:
Phase:
This trial was for people with advanced melanoma and a change in a gene called BRAF. It compared taking tablets every day to having regular breaks in treatment.
The trial was open for people to join between 2017 and 2020. The team finished analysing the results in 2023
More about this trial
Doctors often use dabrafenib and trametinib to treat advanced melanoma skin cancer that has a change (
Dabrafenib and trametinib are both types of targeted treatment called cancer growth blockers. They block the signals that cancer cells need to divide and grow.
We already knew from research that having breaks from some treatments can help them work for longer. Researchers wanted to find out if this was the case for dabrafenib and trametinib.
The people taking part were put into a treatment group at random:
- half took dabrafenib and trametinib tablets every day (continuous treatment)
- half had regular breaks in treatment (intermittent treatment)
The main aims of this trial were to find out if:
- people were happy to take part and took tablets on the right days
- there was a difference in people’s quality of life
- intermittent treatment worked as well as continuous treatment
Summary of results
A total of 79 people with advanced melanoma joined this trial:
- 40 had treatment every day (continuous treatment)
- 39 had regular treatment breaks (intermittent treatment)
The research team looked at how long it was before the melanoma started to grow. They found it was:
- 10.7 months for those who had continuous treatment
- 8.5 months for those who had intermittent treatment
When they looked at how many people’s melanoma responded to the treatment, they found it was:
- nearly 8 out of 10 (77%) who had continuous treatment
- nearly 6 out of 10 (57%) who had intermittent treatment
They also looked at whether people had small pieces of genetic material from cancer cells in their blood. This is called circulating tumour DNA, or ctDNA. They found that people who had ctDNA in their blood before they started treatment did less well.
Quality of life
The research team looked at people’s
Side effects
The research team looked at how many people had side effects. They found it was higher in the continuous treatment group:
- nearly 9 out of 10 (88%) who had continuous treatment
- nearly 8 out of 10 (76%) who had intermittent treatment
Then they looked at how many people had more severe side effects. They found it was higher in the intermittent group:
- just over 4 out of 10 (42%) who had continuous treatment
- more than 5 out of 10 (53%) who had intermittent treatment
Conclusion
The research team concluded that having treatment breaks did not help dabrafenib and trametinib work better. This was for advanced melanoma that could not be removed or had spread to another part of the body.
They suggest it could be useful for people who are having a lot of side effects from continuous treatment.
Sometimes trials show a different way of giving treatment isn’t useful for a particular type or stage of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.
Where this information comes from
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently
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.
Chief Investigator
Dr Pippa Corrie
Supported by
Cambridge University Hospitals NHS Foundation Trust
NIHR Research for Patient Benefit (RfPB) Programme
Cancer Research UK
University of Oxford
Oxford University NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040