Targeted Therapy and Avelumab in Merkel Cell Carcinoma (GoTHAM)

• Drug: Avelumab
• Radiation: External Beam Radiation Therapya treatment that uses controlled doses of radiation to damage or kill cancer cells (EBRT)
• Radiation: Lutetium-177 (177Lu)-DOTATATE

Inclusion Criteria

• Patient is 18 years of age or older and who has provided written informed consent.
• Patient has histologically confirmed metastatic MCC.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 .
• Willing and able to comply with all study protocol requirements for the duration of the study.
• Patient must have measurable disease by CT or MRI per RECIST version 1.1 criteria.
• Patient is treatment naïve (no prior systemic therapy for unresectable or metastatic MCC). Note that prior chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells is permitted in the adjuvant setting for loco-regional disease. Prior radiation is permitted for treatment of the primary or loco-regional disease.
• At least 2 weeks since the completion of prior therapy, including surgery or radiotherapy.
• Screening laboratory values, obtained within 14 days prior to registration/randomisation must meet the criteria specified in the protocol.
• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception
• WOCBP must have a negative serum or urine pregnancy test within within 7 days prior to the start of avelumab treatment and should be performed every 4 weeks in line with other safety bloods or clinical reviews.
• Male patients who are sexually active with a WOCBP must use any contraceptive method with a failure rate of less than 1% per year.
• Patient must be agreeable to have archival tumour material collected