A trial comparing 2 ways of giving dabrafenib and trametinib for advanced melanoma (INTERIM)

Cancer type:

Melanoma
Secondary cancers
Skin cancer

Status:

Results

Phase:

Phase 2

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 (mutation Open a glossary item) in the BRAF gene Open a glossary item. This means melanoma that can’t be removed with surgery or has spread to another part of the body. 

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 quality of life Open a glossary item 6 months after starting treatment. They found it was a little better in those having continuous treatment.

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 peer reviewed Open a glossary item or published in a medical journal yet. The figures we quote above were provided by the research team. 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

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

Last review date

CRUK internal database number:

15242

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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