The Georgetown Lombardi Comprehensive Cancer Center and MedStar Georgetown University Hospital embarked on a nationwide clinical trial Sept. 1 that will compare two melanoma drugs.
ECOG-ACRIN Cancer Research Group, an organization that designs and conducts cancer research on adults who have or are at risk of developing cancer, is conducting the study and currently recruiting patients. Melanoma is the fifth most common cancer in American men and the seventh most common cancer in American women.
Lombardi Center Deputy Director Michael Atkins will lead the trial to its completion in five years.
The study will determine the optimal sequence of two distinct treatment regimens. One directly targets the melanoma cells, while the other restores the activity of immune cells that can attack the cancer.
“One regimen involves a combination of pills that block a pathway within tumor cells, which causes the tumor cells to self-destruct in the majority of patients,” Atkins said. “The second approach is a combination of specific antibodies that reactivates the patient’s immune system against the melanoma.”
Both regimens have been shown in previous clinical trials to be effective in treating patients with advanced melanoma.
Lombardi Center Director Louis Weiner said Atkins’ expertise in this area of clinical study and his intuition about the future of the cancer treatment field make him an excellent leader for the job.
“Dr. Atkins joined Georgetown Lombardi just a few years ago and brought with him innumerable talents,” Weiner wrote in an email to The Hoya. “He is a well-respected leader in the field of immunotherapy and has particular interest in treating melanoma. His expertise is evident in the vision he had to design this national clinical trial — predicting how and when the field would progress.”
Atkins emphasized that this trial can provide more insight into which sequence of treatments should be used first on different types of patients.
“The question in this trial is, do you start with the highly effective pills, and use the highly effective immunotherapy only after the pills stop working?” Atkins said. “Or do you start with the immunotherapy and only use the pills for the patients whose disease is not eradicated by the immunotherapy?”
Approximately 300 people with advanced melanoma will be recruited from cancer centers nationwide— including the Lombardi Center —to take part in the clinical trial. Half the patients will be randomly assigned to receive treatment using the pills first. The other half will begin treatment with the immunotherapy drugs.
If the regimen stops working for patients in either group, indicating that their cancer has become resistant to the initial treatment, they will receive the other drug combination. After patients finish their treatment regimens — which can take up to two years — their physicians will continue to monitor side effects for up to five years.
Participating patients will be asked to report their experiences on the two regimens using standardized questionnaires. This will allow researchers to better understand the symptoms, side effects and toxicities of the treatments, according to an ECOG-ACRIN Group press release emailed to The Hoya.
“The trial gives patients the potential to cross over and receive the other treatment approach because researchers already know that for many patients, melanoma can be highly aggressive and existing treatments often stop working,” a spokesman from ECOG-ACRIN Group wrote. “As a result, advanced melanoma patients and their physicians find themselves with many treatment options but few answers to questions surrounding how and when to use these new approaches.”
Atkins also highlighted the potential contributions this trial could make to further melanoma treatment studies.
“We hope to identify the regimen that optimally produces long-term survival in patients with advanced melanoma,” Atkins said. “We also hope to uncover unique features of our patients who might respond better to one treatment sequence versus the other sequence, and also try to understand the properties related to resistance to a particular therapy that might help us develop better treatments in the future.”
The National Cancer Institute will sponsor the clinical trial. The ECOG-ACRIN Group will also receive funding support from Novartis, the company that commercializes the two oral drugs in the first regimen, and from Bristol-Myers Squibb, the manufacturer of the antibodies used in the immunotherapy regimen.
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