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Study on Cemiplimab and Mitotane for Patients with Advanced Adrenocortical Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called adrenocortical carcinoma, which affects the outer layer of the adrenal glands. The study is investigating the use of a treatment called cemiplimab, also known by its code name REGN2810. Cemiplimab is a type of immunotherapy, which means it helps the body's immune system fight cancer. The trial will also involve another medication called Lysodren, which contains the active substance mitotane. Lysodren is used to treat cancer by interfering with the growth of cancer cells.

The purpose of this study is to evaluate how effective cemiplimab is as a maintenance treatment for patients with advanced adrenocortical carcinoma who have not shown disease progression after initial treatment. Participants in the study will receive cemiplimab through an intravenous infusion, which means the medication is given directly into a vein. The study will also include a comparison with a placebo to assess the effectiveness of the treatment. The trial will last for a period of up to 36 months, during which participants will have regular clinic visits to monitor their health and the effects of the treatment.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The main goal is to see if cemiplimab can help prevent the cancer from getting worse and to understand its impact on the overall quality of life and survival of the patients. The study will also collect information on any adverse effects experienced by participants to ensure the safety and effectiveness of the treatment. This research aims to provide valuable insights into the potential benefits of cemiplimab for individuals with advanced adrenocortical carcinoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age, medical history, and previous treatments.
A comprehensive health assessment is conducted, including blood tests and other necessary evaluations to ensure adequate organ and bone marrow function.
Step 2
Treatment initiation
The treatment phase begins with the administration of cemiplimab, a medication used as a maintenance therapy for advanced adrenocortical cancer.
Cemiplimab is given through an IV infusion (intravenous infusion), which means it is delivered directly into the bloodstream through a vein. The dosage is 350 mg, and the frequency of administration is determined by the study protocol.
Step 3
Ongoing treatment and monitoring
Regular clinic visits are required to monitor the response to the treatment and to manage any side effects. These visits include physical examinations, blood tests, and other assessments as needed.
Patients are asked to complete questionnaires to evaluate their quality of life and any symptoms experienced during the study.
Step 4
End of treatment
The treatment with cemiplimab continues until the study's end date or until it is determined that the treatment is no longer beneficial.
After completing the treatment, follow-up visits are scheduled to monitor the patient's health and to gather information on long-term outcomes.

Who can join the trial?

18 criteria

Men and women who are over 18 years old.
Willing and able to attend clinic visits and follow study-related procedures.
Willing and able to provide informed consent, which is a document that explains the study and confirms your agreement to participate.
Able to understand and complete questionnaires related to the study.
Patients with a confirmed diagnosis of adrenocortical carcinoma (ACC), a type of cancer affecting the adrenal glands.
Have previously received a treatment called EDP-M and, if needed, had surgery to reduce the size of the tumor.
No worsening of the disease after the first 4 to 6 cycles of EDP-M treatment.
Have an ECOG Performance Status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
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Have adequate organ and bone marrow function, which includes:
- Hemoglobin levels greater than 9.0 g/dL (a measure of red blood cells).
- ANC (Absolute Neutrophil Count) greater than 1.5 x 10⁹/L (a type of white blood cell).
- Platelet count greater than 75 x 10⁹/L (cells that help with blood clotting).
- Serum creatinine less than 1.5 times the upper limit of normal or estimated creatinine clearance greater than 30 mL/min (measures of kidney function).
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  Adequate liver function, including:
  - Total bilirubin less than 1.5 times the upper limit of normal.
  - AST and ALT (liver enzymes) both less than 3 times the upper limit of normal.
  - ALP (alkaline phosphatase) less than 2.5 times the upper limit of normal.
  - Women who can become pregnant must agree to use effective birth control methods during the study and for 6 months after treatment ends. They must also have a negative pregnancy test within 24 hours before starting the study drug.
  - Women must not be breastfeeding.
  - Men must agree to use effective birth control methods during the study and for 6 months after treatment ends. They must also agree not to donate sperm during this time.

Who cannot join the trial?

8 criteria

Patients who have not completed 4 to 6 cycles of EDP-M treatment. EDP-M is a combination of drugs used to treat certain cancers.
Patients whose disease has progressed after the EDP-M treatment.
Patients who are not diagnosed with advanced adrenocortical carcinoma.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Patients with other serious health conditions that could interfere with the study.
Patients who are participating in another clinical trial.

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Universita Degli Studi Di Brescia
Brescia, Italy

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Investigated drugs

Cemiplimab is a type of immunotherapy used in this clinical trial. It works by helping your immune system recognize and attack cancer cells. In this study, cemiplimab is being tested as a maintenance treatment for patients with advanced adrenocortical cancer. The goal is to see if it can help keep the cancer from getting worse after patients have already received some initial chemotherapy treatments.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a maintenance treatment for advanced adrenocortical carcinoma, a rare type of cancer affecting the adrenal glands. The main goal of using cemiplimab is to help prevent the cancer from progressing after initial treatment cycles. At the molecular level, cemiplimab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug, which means it helps the body's immune system fight cancer.

Investigated diseases

Adrenocortical carcinoma – Adrenocortical carcinoma is a rare cancer that originates in the outer layer of the adrenal glands, which are located on top of the kidneys. This disease involves the abnormal growth of cells in the adrenal cortex, which can lead to the production of excess hormones. As the carcinoma progresses, it may cause symptoms such as abdominal pain, weight loss, and hormonal imbalances. The tumor can grow and potentially spread to other parts of the body, including the liver and lungs. The progression of the disease can lead to increased pressure on surrounding organs and tissues. The growth rate and spread of the carcinoma can vary significantly among individuals.