Merkel cell carcinoma is a rare, highly aggressive neuroendocrine skin cancer that affects around 300 Australians each year. Australia has the highest incidence of this cancer in the world and cases are rapidly increasing.
Even when diagnosed early, Merkel cell carcinoma has a high risk of returning, with around one-third to one-half of patients experiencing recurrence within two years.
Merkel cell carcinoma can very quickly spread to other sites of the body and is the most lethal type of skin cancer. Only around 14% of patients who develop advanced metastatic Merkel cell carcinoma are expected to survive for five years.
Treatment strategies to complement surgery and / or radiotherapy are urgently needed to prevent the cancer from metastasising and improving the survival rates for Merkel cell carcinoma patients.
The I-MAT trial, led by Melanoma and Skin Cancer Trials Ltd. (MASC Trials), is investigating the use of an immunotherapy drug after patients with early-stage Merkel cell carcinoma have had initial surgery and / or radiotherapy treatment for the cancer.
I-MAT will determine if a six-month treatment regime of Avelumab is well-tolerated and can eliminate residual microscopic cancer cells, thus reducing the risk of the cancer reoccurring and improving the overall outcomes for patients with early-stage Merkel cell carcinoma.
The trial aims to enrol 132 participants with stage I-III Merkel cell carcinoma throughout Australia, including capital cities and many regional towns.
Participants in the phase II, prospective, randomised, placebo-controlled, multi-institutional trial will receive either Avelumab or a placebo for six months, and have follow-up assessments for five years.