Phase II Study of Cemiplimab Maintenance Therapy After First-Line Chemotherapy in Adults with Advanced Adrenocortical Carcinoma

What this Trial Is About

Researchers are evaluating cemiplimab as a maintenance immunotherapy for patients with advanced Adrenocortical Carcinoma ACC who have achieved disease response or stabilization after first-line chemotherapy. This phase II, single-arm study aims to determine if cemiplimab can delay or prevent the progression of ACC, a rare cancer with limited treatment options, especially after failure of standard therapies. The study is conducted at ASST Spedali Civili Hospital in Brescia, Italy. Participants will receive cemiplimab at a dose of 350 mg intravenously every three weeks as maintenance treatment following initial chemotherapy with the EDP-M regimen etoposide, doxorubicin, cisplatin plus mitotane. The study explores whether adding cemiplimab can enhance antitumor activity while avoiding additional toxicities or drug interactions. Maintenance therapy continues for up to 36 months, monitoring patient response and safety. During the study, participants will undergo regular assessments to monitor progression-free survival, overall survival, quality of life, and safety of cemiplimab maintenance therapy. These evaluations include clinical visits, laboratory tests to confirm organ and bone marrow function, and questionnaires assessing quality of life. The trial lasts up to 36 months, with continuous follow-up to gather data on treatment effects and tolerability.

Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer