Recruiting

Study of Pembrolizumab and Chemotherapy for Patients with Locally Advanced Sinonasal 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 a type of cancer called locally advanced sinonasal carcinoma, which affects the nasal cavity and sinuses. The study will explore the use of a medication called pembrolizumab, also known by its code name MK-3475, in combination with chemotherapy. Pembrolizumab is a type of treatment that helps the immune system fight cancer cells. The purpose of the study is to evaluate the safety and effectiveness of this combination as a treatment before surgery, known as neoadjuvant therapy, for patients with this type of cancer.

Participants in the study will receive pembrolizumab along with chemotherapy. The treatment is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 48 weeks, during which the effects of the treatment will be closely monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the results with those receiving the actual treatment.

The main goal is to observe how well the cancer responds to the treatment, looking for signs of complete or partial remission, which means the cancer shrinks or disappears. This study aims to provide valuable information on whether pembrolizumab combined with chemotherapy can be a safe and effective option for treating locally advanced sinonasal carcinoma before surgery.

The research process

The trial runs in 6 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 will provide written informed consent. This consent is necessary to participate in the trial and confirms understanding of the study's purpose and procedures.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of locally advanced sinonasal carcinoma and ensuring the disease is measurable based on specific criteria.
The patient's performance status will be evaluated using a standard scale to ensure they are fit to participate.
Step 3
Treatment initiation
The treatment involves the administration of pembrolizumab, a medication given as a solution for infusion. This is combined with chemotherapy as part of the neoadjuvant treatment plan.
The specific dosage and frequency of pembrolizumab will be determined by the study protocol and administered under medical supervision.
Step 4
Ongoing monitoring
Throughout the treatment period, the patient will be closely monitored for safety and response to the therapy. This includes regular medical check-ups and assessments to track the progress of the treatment.
Step 5
Completion of treatment
Upon completion of the treatment regimen, the patient's response to the therapy will be evaluated. This involves assessing the reduction in tumor size and overall health status.
Step 6
Follow-up
After the treatment phase, the patient will continue to be monitored for any long-term effects and overall health outcomes. This follow-up period is crucial for understanding the long-term efficacy and safety of the treatment.

Who can join the trial?

10 criteria

The patient must have a type of cancer called locally advanced sinonasal carcinoma, which has not been treated before and can be treated with local therapies.
The cancer must be at stage III or IVa-b, according to a system that classifies the severity of cancer.
The patient must be willing and able to sign a document that shows they agree to participate in the trial.
The patient must be 18 years of age or older at the time of signing the consent form.
The patient must have a tumor that can be measured using specific medical guidelines.
The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have organs that are working well, as shown by medical tests done within 15 days before starting treatment.
Male patients must agree to use birth control during the treatment and for at least 180 days after the last dose, and they should not donate sperm during this time.
Female patients must not be pregnant or breastfeeding and must agree to use birth control during the treatment and for at least 180 days after the last dose, unless they are not able to have children.
The patient must provide a sample of their tumor tissue, preferably a newly obtained biopsy.

Who cannot join the trial?

7 criteria

Patients with other types of cancer that are not the specific type being studied.
Patients who have had a different cancer treatment recently.
Patients with serious health problems that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients with allergies to the study medications.
Patients who are participating in another clinical trial.

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Verified sites

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

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Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
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Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
Pavia, Italy

Trial locations

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. In this study, pembrolizumab is given before surgery to shrink the tumor and make it easier to remove.
Chemotherapy
refers to a group of cancer-fighting drugs used in this trial to kill or slow the growth of cancer cells. These drugs are given before surgery to reduce the size of the tumor, making it easier to remove and potentially improving the outcome of the surgery.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently well-established in medical literature as an immunotherapy drug used to treat various types of cancer. In this trial, it is being investigated for its effectiveness in treating locally advanced sinonasal carcinoma. Pembrolizumab works by blocking a specific protein on immune cells, allowing them to better detect and attack cancer cells. It is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Locally Advanced Sinonasal Carcinoma – This is a type of cancer that occurs in the nasal cavity and paranasal sinuses, which are air-filled spaces around the nose. It is considered "locally advanced" when the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. The disease often begins with symptoms such as nasal obstruction, nosebleeds, or facial pain. As it progresses, it may cause more severe symptoms, including vision problems or changes in facial appearance. The growth of the tumor can affect nearby structures, leading to complications. The progression of the disease depends on various factors, including the specific location and size of the tumor.