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Cemiplimab maintenance treatment for advanced adrenocortical cancer
EU CTIS ID: 2024-520449-21-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and females >18 years of age
- 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.
- Patients with histologically confirmed ACC
- Previous induction therapy with EDP-M followed by cytoreductive surgery if indicated
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 situ, or other treated malignancies where there has been no evidence of disease for at least 5 years.
- 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 CHF NYHA Class III or IV.
- Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
See the full eligibility criteria
Who can join
- Male and females >18 years of age
- 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.
- 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 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)
- 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;
- 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 patients must not donate sperm for the time period specified above.
What rules you out
- 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.
- 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 CHF NYHA Class III or IV.
- 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
- 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 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.
- History of active tuberculosis (TB, Bacillus Tuberculosis).
- Untreated brain metastasis that may be considered active.
- 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 equivalent hydrocortisone dose) will be accepted.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.