JAVELIN Merkel 200 Study – Metastatic Merkel Cell Cancer

STUDY BASICS

Have you been diagnosed with metastatic Merkel cell carcinoma, but have not had any treatment yet? If so, you may be able to participate in a research study to find out if an investigational cancer immunotherapy drug called avelumab is safe and effective in treating metastatic Merkel cell carcinoma.

STUDY PURPOSE

Merkel cell carcinoma (MCC) is a very rare type of skin cancer that occurs when Merkel cells (cells found in the top layer of the skin) grow out of control. Merkel cell carcinoma tends to grow and spread (metastasize) quickly, and is likely to come back after treatment. Current treatment options include surgery, radiotherapy and chemotherapy. The purpose of this study is to help researchers find out if an investigational cancer immunotherapy drug called avelumab is safe and effective in treating metastatic Merkel cell carcinoma in patients who have not had any previous treatment for their metastatic cancer. Avelumab is an antibody that works by blocking proteins that help cancer cells grow, and by stimulating the immune system to attack cancer cells.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Have metastatic Merkel cell cancer (cancer that has spread to other parts of the body)
• Have not received any previous treatment for metastatic Merkel cell cancer
• Are in reasonably good health, meaning you are capable of normal daily activities

WHAT PARTICIPANTS CAN EXPECT

Participation involves multiple visits and phone calls over the course of one year. During an initial visit, participants will have tests and assessments to find out if they qualify for the study. Following the initial visit, qualified participants will receive avelumab as a 1-2 hour intravenous (IV) infusion into a vein once every two weeks until your doctor decides to stop study treatment. During the study, participants will also have physical exams, CT or MRI scans, an echocardiogram, blood and urine tests, serum and plasma studies, infectious disease tests, and collection of blood biomarker and tumor tissue samples.