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Study of Pembrolizumab for Patients with Advanced Adrenocortical Carcinoma

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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 the effects of a medication called pembrolizumab in treating a type of cancer known as adrenocortical carcinoma. Adrenocortical carcinoma is a rare cancer that affects the outer layer of the adrenal glands, which are located on top of the kidneys and produce important hormones. The purpose of this study is to evaluate how effective and safe pembrolizumab is for patients with advanced stages of this cancer.

Participants in the study will receive pembrolizumab, which is given as an injection into a vein. The study will monitor how the cancer responds to the treatment over time, including whether the cancer shrinks or stops growing. The study will also look at how long patients live without the cancer getting worse and how long any positive effects of the treatment last. Additionally, the study will assess the overall survival of patients and their quality of life during the treatment.

Throughout the study, researchers will keep track of any side effects or adverse events that participants may experience, whether they are related to the treatment or not. The study aims to provide valuable information about the potential benefits and risks of using pembrolizumab for treating advanced adrenocortical carcinoma, which could help improve future treatment options for this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide an informed consent form. This confirms understanding and agreement to participate in the trial.
Eligibility criteria include being over 18 years old, having a confirmed diagnosis of adrenocortical carcinoma, and meeting specific health requirements such as adequate bone marrow and organ function.
Step 2
Treatment administration
The patient will receive pembrolizumab, a medication administered through intravenous use. This means the drug is given directly into a vein.
The treatment aims to evaluate the effectiveness of pembrolizumab in managing advanced, progressive adrenocortical carcinoma.
Step 3
Monitoring and evaluation
Throughout the trial, the patient's response to the treatment will be closely monitored. This includes assessing the Objective Response Rate (ORR), which measures the percentage of patients whose cancer shrinks or disappears after treatment.
Other key measures include Progression-Free Survival (PFS), which tracks the length of time during and after treatment that the patient lives with the disease without it getting worse, and Overall Survival (OS), which is the duration the patient lives from the start of the trial.
Step 4
Quality of life assessment
The patient's quality of life will be evaluated using the QLQ-C30 questionnaire. This tool helps to understand the impact of the treatment on daily living and overall well-being.
Step 5
Adverse events monitoring
The trial will also track any adverse events, which are unwanted effects of the treatment. These are categorized as Adverse Events (AEs) and Serious Adverse Events (SAEs), and will be recorded according to established criteria.

Who can join the trial?

12 criteria

Sign an informed consent form to participate in the study. This means you agree to join the study after understanding what it involves.
Be over 18 years old.
Have a confirmed diagnosis of adrenal cortex cancer. This means a doctor has verified the presence of this type of cancer through tests.
Have a general health condition that is assessed as less than 2 on the ECOG scale. The ECOG scale is a way to measure how well you can perform daily activities.
Have a measurable disease according to RECIST 1.1. RECIST 1.1 is a set of guidelines used to measure how cancer responds to treatment.
Show confirmed progression of the disease according to RECIST 1.1 within the last 6 months, after receiving at least one line of treatment with EDP or EDP-M. This means the cancer has worsened despite previous treatments.
Have adequate function of the bone marrow and internal organs, which includes:
- Hemoglobin level of at least 9 grams per deciliter, neutrophils greater than 1500 per cubic millimeter, and platelets greater than 100,000 per cubic millimeter. These are measures of blood health.
- Bilirubin level no more than 2 times the upper limit of normal, and Alat and AST levels no more than 3 times the upper limit of normal (or 5 times if there are liver metastases). These are measures of liver function.
- Creatinine clearance greater than 40 milliliters per minute. This measures kidney function.
- Coagulation parameters (INR, PT, APTT) less than 1.5 times the upper limit of normal, unless you are on anticoagulation therapy, in which case these should be within the recommended range for you. These are measures of blood clotting ability.
- For women of reproductive age: Have a confirmed negative pregnancy test result and use double barrier contraception. This means using two forms of birth control to prevent pregnancy.
- For men of reproductive age: Use double barrier contraception. This also means using two forms of birth control.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer other than adrenocortical carcinoma cannot participate. Adrenocortical carcinoma is a rare cancer that starts in the outer layer of the adrenal glands, which are small glands located on top of each kidney.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups, so those outside these groups are excluded.
Patients who are not experiencing advanced or worsening stages of the cancer cannot participate. The study focuses on those with advanced progressive cancer, meaning the cancer is in a later stage and is getting worse.
Patients who are unable to follow the study procedures or who have conditions that might interfere with the study results cannot participate.
Patients who are part of a vulnerable population that the study cannot safely include are excluded. This means people who might be at higher risk of harm or who cannot give informed consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Verified
Cracow, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to treat advanced, progressive adrenocortical carcinoma. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is a type of immunotherapy known as a checkpoint inhibitor, which blocks a specific protein on cancer cells, allowing the immune system to better target and destroy them.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating advanced, progressive adrenocortical carcinoma. Pembrolizumab is primarily used for its immune-boosting properties, helping the body's immune system to detect and fight cancer cells. At the molecular level, it works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

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 can cause the adrenal glands to produce excess hormones, leading to symptoms such as high blood pressure, weight gain, and changes in mood or behavior. As the cancer progresses, it may spread to other parts of the body, including the liver, lungs, and bones. The growth of the tumor can lead to abdominal pain or a feeling of fullness. The progression of adrenocortical carcinoma can vary, with some tumors growing slowly while others may advance more rapidly.