Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study ID
NCT07085572
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adrenal Cortical Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 18, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab added to the standard maintenance therapy with mitotane

Primary Outcome Measure

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 [ Time Frame: 36 months ]

Central Contacts

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