New Clinical Trial for BRAFV600-Advanced Melanoma Currently Recruiting Patients

New Clinical Trial for BRAFV600-Advanced Melanoma Currently Recruiting Patients

A new clinical trial, entitled “Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma” is actively recruiting patients to test two new treatments for advanced melanoma. These two therapies work through different mechanisms but were previously shown to effectively treat advanced melanoma.

A research team at the ECOG-ACRIN Melanoma Group are conducting the study, which consists in administering two different treatment combinations. Enrolled patients will be divided in two groups:

– Half will initially receive a combination of two investigational immunotherapy drugs; if in this group of patients the treatment fails and patients’ cancer progresses, then they will be submitted to a second distinct treatment of two drugs that block signalling pathways sustaining tumor growth and survival.

– The other half will receive the same treatments but in a reverse other, i.e., patients will receive first the combination of the two signalling pathway inhibitors and if treatment fails and disease progresses then the two immunotherapies will be administered.

The immunotherapy drug combination used in the trial consists of ipilimumab and nivolumab, which will be administered to advanced melanoma patients for a maximum period of two years. The drug combination targeting tumor growth and survival consists of dabrafenib and trametinib.

Michael B. Atkins, MD, a medical oncologist and deputy director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC and study chair commented, “After many years of research we’ve ended up with exciting and effective new combination treatment regimens. Now we need to figure out how to sequence these treatment regimens in order to best extend the lives of our patient. To be better, one sequence should significantly improve the number of patients alive at two and three years from the start of treatment when compared to the other sequence.”

To be considered for the trial, patients need to be positive for a specific mutation – BRAFV600 –  as dabrafenib-trametinib directly targets melanoma cells carrying this mutation. As Dr. Atkins explained, “We have an approved two-drug combination, dabrafenib and trametinib, which works by directly attacking BRAF-mutated melanomas. We also have two immunotherapy options, ipilimumab and nivolumab, each approved for separate use, that work in combination to unleash the body’s own immune system to attack the cancer. The question that remains is which of the two drug combinations should be used first and in whom?”

Additionally, exclusion criteria include patients who have already been treated with systemic therapies against melanoma or those that have already received the agents used in the trial.

The trial identifier is NCT02224781 and more information can be found here and in the ECOG-ACRIN website.