Actively Recruiting
Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2025-10-06
31
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients older than 18 years
- Histologically confirmed diagnosis of Adrenocortical Carcinoma (ACC)
- Previous induction treatment with EDP-M chemotherapy followed by cytoreductive surgery if needed
- No disease progression after 4 to 6 cycles of first-line EDP-M chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function including:
- Hemoglobin greater than 9.0 g/dL
- Absolute neutrophil count greater than 1.5 x 10^9/L
- Platelet count greater than 75 x 10^9/L
- Serum creatinine less than 1.5 times the upper limit of normal (ULN) or creatinine clearance greater than 30 mL/min
- Liver function with total bilirubin less than 1.5 x ULN (or up to 3 x ULN with documented Gilbert's syndrome), AST and ALT less than 3 x ULN, and alkaline phosphatase less than 2.5 x ULN
- Women of child-bearing potential must agree to use at least one highly effective contraception method during treatment and for at least 6 months after treatment ends, and have a negative pregnancy test within 24 hours before starting the study drug
- Women must not be breastfeeding
- Men must agree to use contraception during treatment and for 6 months after, and not donate sperm during this time
- Able and willing to comply with clinic visits and study procedures
- Able to provide informed consent
- Able to understand and complete study questionnaires
You will not qualify if you...
- History of recent or active cancer except certain treated cancers with no disease for at least 5 years
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint inhibitors
- Receipt of live vaccine within 30 days before first study treatment
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Immunodeficiency or systemic steroid therapy exceeding 10 mg prednisone equivalent (with some steroid use allowed if on mitotane)
- Uncontrolled HIV, Hepatitis B, or Hepatitis C infection
- History or current non-infectious pneumonitis requiring steroids
- Active infection needing systemic treatment
- Significant cardiovascular disease including recent heart attack or severe heart failure
- Pregnancy or breastfeeding
- Inability or unwillingness to use effective contraception during and after the study
- History of active tuberculosis
- Untreated active brain metastases
- Known allergy or hypersensitivity to cemiplimab ingredients
- History of solid organ transplant except corneal transplant
- Prior stem cell transplantation
- ECOG performance status of 2 or higher
AI-Screening
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Trial Site Locations
Total: 1 location
1
S.C. Oncologia - ASST Spedali Civili di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
Research Team
A
Aldo Roccaro, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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