A trial of vemurafenib for children with advanced melanoma (BRIM-P)

Cancer type:

Children's cancers
Melanoma
Secondary cancers
Skin cancer

Status:

Results

Phase:

Phase 1

This trial looked at a drug called vemurafenib for children and teenagers with advanced melanoma. It was for children and young people aged 12 to 17 whose melanoma:

  • had grown into surrounding tissues and couldn’t be removed with surgery or
  • had spread to another part of the body 

The trial was open for people to join between 2011 and 2015. The team published the results in 2018. There is a link to more information in the ‘Summary of results’ section below.

More about this trial

When this trial was done, vemurafenib (RO5185426) was already being used to treat adults. Doctors wanted to find out whether is was a good treatment option for children with advanced melanoma.

Vemurafenib is a type of targeted cancer drug called a BRAF inhibitor. BRAF is a protein that makes the cancer cells grow and divide. Blocking BRAF may stop cancer cells growing.

Vemurafenib is only useful for people who have a change (mutation Open a glossary item) in the BRAF gene. The researchers checked this for each person as part of the trial.

There were 2 parts to this trial.

People in part 1 had different doses of vemurafenib. This is called a dose escalation study. It helps doctors find the best dose to give.

People in the part 2 were due to have the best dose found in part 1. But this part didn’t go ahead as planned. 

The main aims of this study were to find out:

  • the best dose of vemurafenib to give children 
  • how well it works
  • more about the side effects 
  • what happens to vemurafenib in the body

Summary of results

We aim to add a lay summary of results to all the trials on our database. Unfortunately we have not been able to include a summary for this one.

There is more information about the results in the link below.

BRIM-P: A phase I, open-label, multicenter, dose-escalation study of vemurafenib in pediatric patients with surgically incurable, BRAF mutation-positive melanoma
Julia C. Chisholm and others
Pediatric Blood Cancer, 2018. Volume 65, issue 5.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

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 Julia Chisholm

Supported by

NIHR Clinical Research Network: Cancer
Roche

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9147

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

Last reviewed:

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