Mercury

The Merkel cell carcinoma (MCC) is an extremely rare cutaneous epithelial malignancy with highly aggressive behavior.
Surgery currently represents the standard of care for localized disease and postoperative RT on the tumor bed and lymphatic drainage is now recommended by international guidelines and should be evaluated by a multidisciplinary team.
However, despite multimodal treatment and aggressive surgery, disease relapse is extremely common and the prognosis of MCC is remarkably poor with lower survival rates compared with melanoma or other skin malignancies. The 5-year OS is, in fact, estimated around 51, 35, and 14 % for local, nodal, and distant disease.
Due to the rarity of MCC, the quality of the data on medical treatment is poor.

Historically, metastatic MCC has been treated with a combination of platinum- based chemotherapy and etoposide that provided relatively high response rates, but short-lasting response and unsatisfactory survival advantage. In recent years, immunotherapy agents showed promising results. Given the rapid and profound responses observed in patients with metastatic MCC, there is a great interest in exploring immunotherapy, alone or in combination, in earlier disease stages.
Based on available evidence, we design this multicenter, single-arm, open-label, phase 2, window of opportunity trial directed to assess the activity of one cycle of preoperative retifanlimab plus platinum-etoposide chemo-immunotherapy regimen in patients with resectable MCC (stage IIA-III).

– Histologically confirmed diagnosis of MCC amenable for radical surgery as defined by local or institutional surgical practices, based on multidisciplinary team assessment. Subjects must have one of the following stages of disease:
a. Stage IIA – IIB- III (according to the AJCC staging system 8th edition)
b. Local/Regional recurrent disease after primary surgery, as defined as total disease burden ≥ 1 cm diameter amenable for a radical intent surgery.
– No prior systemic treatment or neoadjuvant radiation therapy.
– Adequate hematopoietic, liver and renal function.
– No history of autoimmune disease.

The primary objective of this trial is to assess the activity of one cycle of preoperative retifanlimab plus platinum-etoposide chemo-immunotherapy regimen as measured in terms of pathological complete response (pCR).