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);
Single group
Cemiplimab
Drug350 mg IV Q3W
Evaluation of efficacy of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4-6 EDP-M cycles
Proportion of patients free from progression at 6 months after the end of first-line chemotherapy
Evaluation of the effect of cemiplimab as a maintenance therapy on Overall Survival (OS)
The time from the date of the study start to the date of death due to any cause will be measured.
Evaluation of the effect of cemiplimab on patients' Quality of Life (QoL)
The QoL will be assesed by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Evaluation of the safety profile of maintenance cemiplimab therapy
The safety profile of maintenance cemiplimab therapy will be evaluated by the frequency of Adverse Effects (AEs) and laboratory abnormalities as graded by NCI CTCAE v5.0.
Evaluation the safety of adding cemiplimab to standard mitotane therapy (Safety run-in phase)
Frequency of occurrence of dose limiting toxicities (DLTs)
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