New Nationwide Clinical Trial Highlights Major Changes in Managing Melanoma

A new nationwide clinical trial comparing two groups of drugs for treating melanoma is marking a new era in the treatment of melanoma and how best to use the latest molecular tools. 

Instead of looking at a single agent and its effectiveness, this trial will look at different drug classes delivered at different time points. In this study, patients will be randomly assigned to either receive an anti-BRAF mutation drug first or an immunotherapy drug first. The patients will receive the other drug combination when and if their cancers become resistant to the treatment.

“After many years of research, we’ve ended up with exciting and effective new combination treatment regimens,” said study investigator, Michael Atkins, MD, who is the deputy director at the Georgetown Lombardi Comprehensive Cancer Center/MedStar Georgetown University Hospital, Washington, DC. “Now, we need to figure out how to sequence these treatment regimens in order to best extend the lives of our patients.”¹

Dr. Atkins, who is also the national chair for the study, said there is an approved two-drug combination (dabrafenib and trametinib) and it 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,” said Dr. Atkins. “The question that remains is which of the two-drug combinations should be used first and in whom?”¹

He said this study addresses an important question, not just for melanoma, but for other cancers where both molecularly targeted therapy and immunotherapy are active. The study will include approximately 300 melanoma patients and they will be followed for up to 5 years. All the patients will be tracked for their symptom burden and overall function. This study is important because it will help clinicians better understand the quality-of-life issues among these patients, and which agents are the most tolerable as well as effective.

The National Cancer Institute (NCI) is providing the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ACRIN) with funding support for this trial. ECOG-ACRIN is receiving additional funding support from Bristol-Myers Squibb, the manufacturer of ipilimumab (Yervoy®) and nivolumab (Opdivo®), and from Novartis, the company that commercializes dabrafenib (Tafinlar®) and trametinib (Mekinist™).

References:

• Georgetown University Medical Center. (2015). Georgetown Lombardi Offers New Melanoma Study Comparing Two Treatment Regimens.