LSU Health New Orleans is recruiting participants to a clinical trial to determine the effectiveness of MK-3475 (pembrolizumab) in treating patients with Merkel cell cancer that cannot be removed by surgery, or controlled with treatment, or has spread to other parts of the body. It is the first systemic intervention for patients with advanced Merkel cell carcinoma. Pembrolizumab is an immunotherapy drug. Immunotherapy works differently than chemotherapy in that it boosts the body’s own natural defense system to help fight cancer. LSU Health New Orleans is one of 11 sites in the country selected to enroll patients in this clinical trial.
Merkel cell carcinoma (MCC) is an aggressive form of skin cancer. It is linked to exposure to ultraviolet rays, but about 80% of cases are associated with a virus called Merkel cell polyomavirus. There are currently no FDA-approved drugs to treat Merkel cell carcinoma. While some patients do respond to chemotherapy, after about three months, the disease typically progresses, leaving patients with few, if any, treatment options. Merkel cell carcinoma took the life of Al Copeland Sr. in 2008. There were no and are still no FDA-approved treatments for Merkel cell carcinoma. After their experience searching for an effective treatment, the Copeland family dedicated themselves to raising funds to help find a cure for this and other cancers, and the Al Copeland Foundation was born. The ACF chose LSU Health New Orleans as its partner in this quest and continues to raise funds for cancer research at LSU Health New Orleans.
“LSU Health New Orleans is one of a few sites able to offer this clinical trial, and patients with advanced Merkel cell carcinoma in our area will no longer have to travel long distances to participate,” notes Dr. Larry Hollier, Chancellor of LSU Health New Orleans.
Pembrolizumab targets a protein on immune system cells called PD-1, for programmed cell death-1. PD-1 inhibits immune system activity. By blocking PD-1, pembrolizumab may stimulate the immune system to identify and destroy cancer cells. Early results of the first 26 patients with advanced Merkel cell carcinoma treated with pembrolizumab were published in April 2016. According to the National Cancer Institute, more than half of the patients in this small clinical study had a complete or partial response to treatment with pembrolizumab, and overall, the responses have been longer-lasting than those typically seen in patients with this very rare cancer who have received chemotherapy.
“This protocol shows how important immunotherapy may be as a new form of treatment in cancer and in particular tumors caused by viruses,” says Dr. Augusto Ochoa, Director of LSU Health New Orleans Stanley S. Scott Cancer Center and co-Principal Investigator.
The clinical trial, sponsored by the National Cancer Institute seeks to enroll a total of 50 patients among the participating sites. Although there are a number of inclusions and exclusions, participants must be 18 years or older, have biopsy-proven or metastatic MCC, measurable disease and a life expectancy of greater than six months. Exclusions include having prior systemic therapy for MCC, radiation therapy within two weeks of beginning study treatment, having active autoimmune disease or other diseases such as congestive heart failure and cardiac arrhythmias, or is pregnant or breastfeeding.
“Pembrolizumab is already approved to treat melanoma and certain lung cancers,” says co-Principal Investigator Dr. Adam Riker, Professor of Surgery and Director of Surgical Oncology at LSU Health New Orleans School of Medicine. “Although Merkel cell carcinoma is a rare disease, as we learn more about pembrolizumab’s clinical activity, another goal of the clinical trial, we hope to learn if it could be beneficial as a treatment option for other cancers caused by viruses as well.”
Other goals of the study include learning more about the duration of response, the incidence of adverse events, overall survival and progression-free survival.
The Al Copeland Foundation donated $100,000 to support this clinical trial, raised with the first annual Chicken Jam event.
“We are excited that the Copeland-LSU Health Sciences Center Partnership in Viruses, Cancer and Immunotherapy is now able to be the driving force to bring the first ever Merkel Cell Carcinoma immunotherapy trials program to the Louisiana and Mississippi areas,” said Al Copeland Jr., Chairman of the Board and CEO of Al Copeland Investments. “The Al Copeland Foundation is proud to invest in immunotherapy right here at home, and we need the community’s help to ensure patients who have Merkel Cell carcinoma in the Gulf State region can be recruited to receive this game changing, possibly lifesaving treatment.”
All participants will be given the study medication, pembrolizumab, by infusion every three weeks for as long as they benefit, up to two years. The visits, which also include a CT scan, EKG or other laboratory procedures, will be approximately four hours long. There may be no benefit to participants, and there are a number of risks. Side effects have been reported in patients receiving this study medication, although most have been reversible. Two of the early participants in the study had to stop treatment after only a couple of infusions, but nearly a year afterwards both patients continued to have tumor responses.
For more information about the Merkel cell carcinoma clinical trial at LSU Health New Orleans, call 504-407-7395.