Conducted by the ECOG-ACRIN Cancer Research Group, the study will begin recruitment soon at cancer centers nationwide including Georgetown Lombardi Comprehensive Cancer Center.
“After many years of research, we’ve ended up with exciting and effective new combination treatment regimens,” explains the study’s chair, Michael B. Atkins, MD, deputy director at Georgetown Lombardi who treats patients at MedStar Georgetown University Hospital. “Now we need to figure out how to sequence these treatment regimens in order to best extend the lives of our patients.”
As Atkins explains, “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?”
Patients in the study will be randomly assigned to either receive the anti-BRAF mutation drugs first or the immunotherapies first. The patients will receive the other drug combination when and if their cancers become resistant to the treatment.
“This study addresses an important question, not just for melanoma, but for other cancers where both molecularly targeted therapy and immunotherapy are active,” Atkins says.
There will be about 300 people taking part in this study who will be followed for up to five years. Most of the exams, tests and procedures in the study are part of the usual care. However, additional exams, tests and surveys are administered to track participants’ symptom burden and overall function. The study drugs have side effects that will be reviewed with study participants prior to their enrollment.
The National Cancer Institute (NCI) is providing ECOG-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™).
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 the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).