Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
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;
• An ECOG PS of 0, 1;
• Adequate organ and bone marrow function documented by:
∙ Hemoglobin \>9.0 g/dL
‣ ANC \>1.5 x 109/L
‣ Platelet count \>75 x 109/L
‣ Serum creatinine \<1.5 ULN or estimated CrCl \>30 mL/min
‣ Adequate hepatic function:
⁃ Total bilirubin \<1.5 x ULN;
• AST and ALT both \<3 x ULN;
• ALP \<2.5 x ULN; Note: For patients with Gilbert's syndrome, total bilirubin ≤3x ULN. Gilbert's syndrome must be documented appropriately as past medical history.
• Women of child-bearing potential (physiologically capable of becoming pregnant) that must agree to follow instructions for methods of contraception (including at least one highly effective contraception method, see study protocol) for the duration of treatment with study drug, and after discontinuation of treatment as long as mitotane plasma levels are detectable and, in any case, at least for 6 months post treatment completion; must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug;
• Women must not be breastfeeding;
• Males that must agree to follow instructions for methods of contraception (see study protocol) for the duration of treatment with study drug, and then for a total of 6 months post treatment completion. In addition, male patients must not donate sperm for the time period specified above;
⁃ Willing and able to comply with clinic visits and study-related procedures;
⁃ Willing and able to provide informed consent signed by study patient or legally acceptable representative;
⁃ Able to understand and complete study-related questionnaires.