NCT07085572

Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Adrenocortical carcinoma (ACC) is a rare malignancy affecting around 0.7-2 persons per one million population per year. The only pharmacological approach approved by FDA and EMA for the treatment of ACC is mitotane, which has an adrenolytic effect causing adrenocortical insufficiency. So, the drug should be administered in association with glucocorticoid replacement for the purpose only of restoring the daily cortisol requirement. Few therapeutic alternatives are available for metastatic ACC patients failing one to two lines of systemic treatment, so immunotherapy could represent a potential new treatment. The immune checkpoint inhibitors are the most promising immunotherapy agents in cancer pharmacology and have been also investigated in ACC. Bases on results of some clinical studies, immunotherapy has achieved long-term control in a small proportion of patients with metastatic ACC. We need to identify the patient subset destined to benefit most from this therapy and at what point in the therapeutic sequence of adrenal carcinoma should immunotherapy be introduced. We also need to implement strategies to overcome the intrinsic immuno-resistance of ACC. The current strategy in the management of advanced ACC is the administration of the EDP (etoposide, doxorubicin, cisplatin) scheme associated with mitotane followed by maintenance mitotane in patients not progressing on chemotherapy. Maintenance immunotherapy could be administered in combination with mitotane, enhancing its efficacy. In addition, the powerful adrenolytic effect of mitotane could keep cortisol production inhibited, facilitating the efficacy of immunotherapy. Maintenance therapy with cemiplimab in ACC patients after first-line chemotherapy may result in enhanced antitumor activity while avoiding potential interactions, including cross-resistance and cumulative toxicity.

Conditions

• Adrenal Cortical Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	350 mg IV Q3W

Timeline

• Start date: 2025-09-18
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-07-25
• Last updated: 2025-10-06

Locations

1 site across 1 country: Italy