New trial offers hope to Stage IV patients

New trial offers hope to Stage IV patients

17 November 2014

A world-first clinical trial led by Melanoma Institute Australia has opened that may benefit patients with advanced melanoma, specifically melanoma tumours that have metastasised to the brain.

Half of all patients diagnosed with Stage IV melanoma will develop brain metastases at some point during their illness, and 20–25% will already have brain metastases when first diagnosed with Stage IV melanoma. Sadly, most patients with brain metastases die within four months and they have limited treatment options available. This is a significant unmet need and one that the clinicians at Melanoma Institute Australia (MIA) are passionate to do something about.

Historically, patients with brain metastases are excluded from clinical trials unless they have been completely treated and stable for a long time. However, because of the incredibly poor prognosis with brain metastases, this is difficult to attain and until recently they have only been treated with local treatments such as surgery or radiotherapy. Systemic chemotherapy historically has shown little effect in brain metastases and so patients with brain metastases have been excluded from these trials.

“The outcome of this trial may well change the treatment paradigm for how doctors treat melanoma patients with brain metastases.”

Associate Professor Georgina Long

This new MIA-led clinical trial is investigating the use of an experimental new therapy called anti-PD-1. This immunotherapy trial is the first in the world to investigate the anti-PD-1 drug, nivolumab, and nivolumab plus ipilimumab specifically in patients with active brain metastases.

“Being able to test the activity of an immunotherapy in the brain is an exciting avenue of research. It offers potential hope not only to the patients who are on the trial but if it proves successful, this has implications for patients around the world,”

Principal Investigator Associate Professor Georgina Long
MIA and The University of Sydney

The trial is being run at MIA in North Sydney, and will also be in collaboration with a number of other research centres along the Eastern seaboard.

Funding from this trial was passionately raised by the community through Melanoma March 2014 and 900KMFORACURE – an event that saw 2 melanoma survivors walk from Sydney to Melbourne to raise melanoma awareness and $160,000 for this trial. Grant funding was also provided by BMS.

As strict inclusion criteria apply, patients interested in going on the trial should speak with their oncologist.