CEMIPLIMAB for Adrenocortical carcinoma

Inclusion criteria

• {"criterion_text":"- Male and females >18 years of age"}
• {"criterion_text":"- Willing and able to comply with clinic visits and study-related procedures."}
• {"criterion_text":"- Willing and able to provide informed consent signed by study patient or legally acceptable representative."}
• {"criterion_text":"- Able to understand and complete study-related questionnaires."}
• {"criterion_text":"- Patients with histologically confirmed ACC"}
• {"criterion_text":"- Previous induction therapy with EDP-M followed by cytoreductive surgery if indicated"}
• {"criterion_text":"- No disease progression after first line 4–6 EDP-M cycles"}
• {"criterion_text":"- An ECOG PS of 0,1"}
• {"criterion_text":"- Adequate organ and bone marrow function documented by: Hemoglobin >9.0 g/dL; ANC >1.5 x 10^9 /L; Platelet count >75 x 10^9 /L; Serum creatinine <1.5 ULN or estimated CrCl >30 mL/min; Adequate hepatic function: (Total bilirubin <1.5 x ULN; AST and ALT both <3 x ULN; ALP <2.5 x ULN)"}
• {"criterion_text":"- Women of child-bearing potential (physiologically capable of becoming pregnant) that must agree to follow instructions for methods of contraception (including at least one highly effective contraception method, see study protocol) for the duration of treatment with study drug, and then for 6 months post treatment completion; must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug;"}
• {"criterion_text":"- Women must not be breastfeeding."}
• {"criterion_text":"- Males that must agree to follow instructions for methods of contraception (see study protocol) for the duration of treatment with study drug, and then for a total of 6 months post treatment completion. In addition, male patients must not donate sperm for the time period specified above."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Uncontrolled HIV, Hepatitis B or Hepatitis C (see protocol for details)."}
• {"criterion_text":"- History of (non-infectious) pneumonitis that required steroids or current pneumonitis."}
• {"criterion_text":"- Active infection requiring systemic therapy."}
• {"criterion_text":"- Significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty / stenting / bypass grafting within the last 6 months OR CHF NYHA Class II-IV or history of CHF NYHA Class III or IV."}
• {"criterion_text":"- Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product."}
• {"criterion_text":"- Patients with a history of solid organ transplant (exception: corneal transplant)"}
• {"criterion_text":"- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation."}
• {"criterion_text":"- ECOG PS ≥ 2"}
• {"criterion_text":"- Pregnancy or breastfeeding."}
• {"criterion_text":"- Continued sexual activity in women of childbearing potential (physiologically capable of becoming pregnant) or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose."}
• {"criterion_text":"- History of active tuberculosis (TB, Bacillus Tuberculosis)."}
• {"criterion_text":"- Untreated brain metastasis that may be considered active."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Administration of a live vaccine within 30 days of the first dose of study treatment."}
• {"criterion_text":"- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)."}
• {"criterion_text":"- Diagnosis of immunodeficiency or systemic steroid therapy (i.e., dosing exceeding 10 mg of prednisone or equivalent). In case of mitotane treatment, a maximum steroid supplementation of 75 mg of cortone acetate (or equivalent hydrocortisone dose) will be accepted."}

Primary endpoints

• {"endpoint_text":"- To evaluate the effect of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4–6 EDP-M cycles.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- OS: time from the date of the study start to the date of death due to any cause.","definition_or_measurement_approach":"OS defined as time from study start to date of death due to any cause."}
• {"endpoint_text":"- QoL: EORTC QLQ-C30 questionnaire.","definition_or_measurement_approach":"Quality of life assessed using the EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.","definition_or_measurement_approach":"Adverse events and laboratory abnormalities graded per NCI CTCAE v5.0."}

Italy

Earliest CTIS Part Ii Submission Date

23-05-2025

Latest Decision Or Authorization Date

05-06-2025

Processing Time Days

13

Number Of Sites

1

Number Of Participants

31

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy