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New treatment option for Adrenal Cortical Carcinoma
Official title Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
ClinicalTrials.gov ID: NCT07085572
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for adrenal cortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
- An ECOG PS of 0, 1;
You likely can't join if
- History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in...
- 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...
- Diagnosis of immunodeficiency or systemic steroid therapy (i.e., dosing exceeding 10 mg of prednisone or equivalent). In case of mitotane treatment...
- Uncontrolled HIV, Hepatitis B or Hepatitis C (see protocol for details);
See the full eligibility criteria
- 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;
- An ECOG PS of 0, 1;
- Adequate organ and bone marrow function documented by:
- Hemoglobin \>9.0 g/dL
- ANC \>1.5 x 109/L
- Platelet count \>75 x 109/L
- Serum creatinine \ 30 mL/min
- Adequate hepatic function:
- Total bilirubin \<1.5 x ULN;
- AST and ALT both \<3 x ULN;
- ALP \<2.5 x ULN; Note: For patients with Gilbert's syndrome, total bilirubin ≤3x ULN. Gilbert's syndrome must be documented appropriately as past medical history.
- 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...
- Women must not be breastfeeding;
- 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...
- Willing and able to comply with clinic visits and study-related procedures;
- Willing and able to provide informed consent signed by study patient or legally acceptable representative;
- Able to understand and complete study-related questionnaires.
- 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...
- 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);
- 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...
- Uncontrolled HIV, Hepatitis B or Hepatitis C (see protocol for details);
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis;
- Active infection requiring systemic therapy;
- 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...
- Pregnancy or breastfeeding;
- 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...
- History of active tuberculosis (TB, Bacillus Tuberculosis);
- Untreated brain metastasis that may be considered active.
- Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
- Patients with a history of solid organ transplant (exception: corneal transplant)
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
- ECOG PS ≥ 2
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Brescia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Brescia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.