New Clinical Trial Led by Lombardi Doctor to Compare Drug Sequences in Treatment of Melanoma

August 31, 2015 — A new nationwide clinical trial that recently opened at Georgetown Lombardi Comprehensive Cancer Center and MedStar Georgetown University Hospital will help doctors determine not only which drugs are most effective, but also how the order in which the drugs are administered affects patient outcomes. Conducted by the ECOG-ACRIN Cancer Research Group, the study will test drug combinations in different sequences to determine the ideal course of treatment for melanoma, a dangerous form of skin cancer.

The trial is in good hands. As the study’s principal investigator and national chair, Michael Atkins, MD, deputy director of Georgetown Lombardi, will lead a team of researchers comparing responses to two different treatment regimens and lend his well-regarded expertise in melanoma research.

“The drug combinations in this the trial have shown the success of innovative modern medicine in slowing the spread of melanoma. Our mission now is to investigate which combination should be administered first,” says Atkins. “This will not only allow us to develop better treatment plans, but will hopefully reduce the number of different regimens endured by future patients.”

Two Combinations, Two Different Approaches

Each regimen has its own distinct method of combating melanoma. The first works by targeting a gene called BRAF with the drugs dabrafenib and trametinib. BRAF provides instructions for making a protein, which in turn relays signals that control the division of cells. Mutations in the gene can result in overactive proteins that fail to appropriately regulate cell growth. Working together, these two drugs inhibit BRAF and its associated proteins, mitigating the effects of such mutations.

Rather than using precision medicine, the other two-drug combination utilizes immunotherapy to fight back against rapidly dividing melanoma cells. Ipilimumab and nivolumab, each approved by the U.S. Food and Drug Administration (FDA) for separate use, help disable the cancer’s defense mechanisms and harness the power of the body’s immune system.

After being informed of the drugs’ side effects, approximately 300 trial patients will be randomly divided into two groups and administered one of these drug combinations. When or if a patient’s cancer resists the first treatment, they will then be given the second drug regimen. Participants will be followed for up to five years. In addition to the typical procedures associated with melanoma treatment, they will also undergo exams to track their symptoms and overall function.

Beyond Melanoma

The results of the sequencing tests have exciting potential to inform future research.

“While this trial focuses specifically on melanoma, it could have significant implications for the treatment of other forms of cancer,” Atkins says. “Immunotherapies, as well as molecular-level and gene-based therapies, are increasingly being recognized as important means of fighting cancer from the ground up. By taking a targeted approach to medicine, we can go beyond treating cancer’s symptoms and begin to understand its underlying causes.”

ECOG-ACRIN is receiving funding for this trial from the National Cancer Institute, with additional 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™).

Atkins reports that he serves or has served recently on advisory boards for Bristol-Myers Squibb, Merck & Co., Genentech, Amgen, Novartis, NeoStem, Alkermes, Infinity Pharm, GSK and Pfizer.

Information about the clinical trial and medical centers that are actively recruiting participants is available here or by calling Georgetown Lombardi at 202-444-4000.

Meghan Lasswell
GUMC Communications