A renowned Georgetown University Medical Center physician will lead a national clinical trial involving new treatments for melanoma. The trial will compare two groups of drugs known for their efficacy in treating the condition and will be conducted by the ECOG-ACRIN Cancer Research Group. Patient recruitment is expected to begin soon at cancer centers across the US, including Georgetown Lombardi Comprehensive Cancer Center.
“After many years of research, we’ve ended up with exciting and effective new combination treatment regimens,” explained in a recent news release 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 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?”
Patients will be randomized into two treatment groups and will initiate treatment either with anti-BRAF mutation drugs or immunotherapeutic drugs. If their cancers become resistant to the treatment, patients will receive another drug combination.
“This study addresses an important question, not just for melanoma, but for other cancers where both molecularly targeted therapy and immunotherapy are active,” Atkins said in the news release.
The study will involve about 300 patients that will be followed for a period of up to five years. Patients’ tests, surveys and exams will be the same as the ones used in standard care. Nevertheless, researchers will track patients’ overall function and symptom burden with other assessment tools. Drugs’ side effects will be reviewed with patients before study enrolment.
ECOG-ACRIN will receive funding from the National Cancer Institute (NCI), and additional funding will be provided by Novartis, the company responsible for the commercialization of dabrafenib (Tafinlar®) and trametinib (Mekinist™), and also by Bristol-Myers Squibb, the manufacturer of ipilimumab (Yervoy®) and nivolumab (Opdivo®).