MCC is a rare and aggressive skin cancer that arises from uncontrolled growth of cells in the skin. Increasing in incidence, approximately 2,000 new cases are reported in the U.S. each year, according to the American Cancer Society. Patients with metastatic or locally-advanced MCC have an extremely poor prognosis, with less than 20% of patients surviving longer than five years. Typically, these patients are treated with a range of drugs, including chemotherapy, which can result in significant side effects. Although new immune therapies have the potential to improve survival, Merkel cell carcinoma is still fatal for a majority of patients who have progressed on or after treatment with a checkpoint inhibitor. This represents an unmet medical need.
Merkel Cell Carcinoma Clinical Trial
A Study of N-803, haNK and Avelumab in Patients with Merkel Cell Carcinoma that Has Progressed After Checkpoint Therapy
This Phase 2, single-arm study will evaluate the combination therapy of Avelumab, haNK, and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients must have progressed on or within six months of completing treatment with either Avelumab or pembrolizumab. Patients will receive treatment for a maximum of two years, with Avelumab and haNK administered every two weeks, and N-803 administered every three weeks. Radiologic evaluation will occur every eight weeks during the first year of treatment, and every twelve weeks during the second year of treatment. (NCT03853317)