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Study of Pembrolizumab for Patients with High-Risk Thyroid 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 thyroid cancer, a type of cancer that affects the thyroid gland, which is located in the neck and produces hormones that regulate metabolism. The study is investigating the use of pembrolizumab, a medication that is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. Pembrolizumab is also known by other names such as Keytruda and is used to help the immune system fight cancer cells.

The purpose of this study is to explore how pembrolizumab works as a treatment before surgery in patients with high-risk thyroid cancer. Participants in the study will receive pembrolizumab to see how it affects their cancer and immune system. The study will involve regular monitoring and assessments to understand the medication's impact on the cancer and the body's immune response.

Throughout the study, researchers will collect and analyze samples to learn more about how pembrolizumab influences the immune system and its ability to target cancer cells. This research aims to provide insights into the potential benefits of using pembrolizumab as a treatment option for thyroid cancer, particularly in cases where the cancer is considered high-risk. The study is expected to continue until 2026, with the goal of improving treatment strategies for thyroid cancer patients.

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, you will be required to provide written informed consent. This means you agree to participate in the trial after understanding all the details and potential risks involved.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and specific characteristics of your thyroid cancer.
You will need to have a confirmed diagnosis of differentiated thyroid carcinoma and be a candidate for surgery. Your cancer should not have been previously treated.
Step 3
Treatment with pembrolizumab
You will receive the medication pembrolizumab, which is administered as an intravenous infusion. This means the medication is given directly into your vein through a needle.
The specific dosage and frequency of the medication will be determined by the study team based on your individual needs and the study protocol.
Step 4
Monitoring and follow-up
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and any side effects.
You will be required to follow specific guidelines regarding contraception if applicable, and you must refrain from donating sperm during the treatment period and for a specified time after the last dose.
Step 5
End of treatment
After completing the treatment phase, further assessments will be conducted to evaluate the outcomes of the therapy.
The study aims to understand the behavior of certain immune cells in response to pembrolizumab and how this affects thyroid cancer.

Who can join the trial?

9 criteria

Participants must be male or female and at least 18 years old on the day they sign the consent form.
Participants must have a confirmed diagnosis of differentiated thyroid carcinoma and be candidates for surgery. They should not have received any prior treatment for this condition.
Female participants must not be pregnant or breastfeeding. They must either not be able to have children or agree to use birth control during the study and for at least 4 months after the last dose of the study treatment.
Male participants must agree to use contraception during the study and for at least 6 months after the last dose of the study treatment. They should also refrain from donating sperm during this period.
Participants must have a risk greater than 20% for persistent or recurrent disease, which includes conditions like a primary tumor larger than 4 cm, certain genetic mutations, or expected incomplete tumor removal.
Participants must have measurable disease based on specific medical criteria (RECIST 1.1).
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means they should be fully active or have some symptoms but be able to carry out light work.
Participants must have adequate organ function, which will be checked with tests done within 10 days before starting the study treatment.
Participants must provide written informed consent to take part in the trial, or a legally acceptable representative must do so on their behalf.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides thyroid cancer cannot participate.
Patients who have received any other treatment for thyroid cancer before the study cannot participate.
Patients with serious heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with known allergies to the study medication cannot participate.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients with a history of drug or alcohol abuse cannot participate.

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Verified sites

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

Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Verified
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being used before surgery to treat high-risk thyroid cancers. The goal is to see if it can shrink the tumors and make them easier to remove, potentially improving the outcomes for patients with this type of cancer.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – Pembrolizumab 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 for its effectiveness in treating high-risk thyroid cancers. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a specific protein called PD-1 on immune cells, which can otherwise prevent these cells from attacking cancer. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Thyroid Cancer – Thyroid cancer is a type of cancer that begins in the thyroid gland, which is located at the base of the neck. It often starts as a small lump or nodule in the thyroid, which may grow slowly over time. As the cancer progresses, it can spread to nearby lymph nodes and, in some cases, to other parts of the body. The disease can cause symptoms such as a noticeable lump in the neck, changes in voice, difficulty swallowing, and neck pain. Thyroid cancer is categorized into different types, including papillary, follicular, medullary, and anaplastic, each with distinct characteristics. The progression and behavior of the disease can vary depending on the type and stage at diagnosis.