This clinical trial is a single-arm, non-randomized, prospective phase II study.
The study aims to evaluate if the maintenance immunotherapy with cemiplimab in patients with AdrenoCortical Carcinoma (ACC), who obtained disease response or stabilization after first-line chemotherapy, may delay/prevent disease progression.
The study will be conducted at ASST Spedali Civili Hospital, Brescia - Italy.
Male and females >18 years of age;
Patients with histologically confirmed ACC;
Previous induction therapy with EDP-M followed by cytoreductive surgery if indicated;
No disease progression after first line 4-6 EDP-M cycles;
History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 5 years;
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor;
Administration of a live vaccine within 30 days of the first dose of study treatment;
Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs);