Recruiting

Study on Reducing Chemotherapy Cycles with Pembrolizumab for Patients with PD-L1-Positive Recurrent or Metastatic Head and Neck 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 known as head and neck squamous cell carcinoma, which can recur or spread to other parts of the body. The study is specifically looking at cases where the cancer is positive for a protein called PD-L1. The trial will explore the effects of reducing the number of chemotherapy cycles when used in combination with a medication called Pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is a type of treatment that helps the immune system fight cancer. The chemotherapy drugs being studied include Fluorouracil, Cisplatin, and Carboplatin, all of which are given through an infusion into a vein.

The purpose of the study is to evaluate how effective and safe it is to use fewer chemotherapy cycles along with Pembrolizumab for treating this type of cancer. Participants in the study will receive these treatments and will be monitored to see how their cancer responds and to check for any side effects. The study will help determine if a shorter course of chemotherapy can still be effective when combined with Pembrolizumab.

Throughout the study, participants will receive regular check-ups and assessments to track their progress. The study aims to provide valuable information on whether reducing chemotherapy cycles can maintain treatment effectiveness while potentially reducing side effects. This research could lead to improved treatment options for patients with PD-L1-positive recurrent or metastatic head and neck squamous cell 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 treatment phase
Upon joining the study, the patient will begin the initial treatment phase. This involves receiving a combination of medications through intravenous infusion.
The medications include fluorouracil, pembrolizumab, cisplatin, and carboplatin. Each of these medications is administered as a solution for infusion, which means they are given directly into the bloodstream through a vein.
The specific dosage and frequency of each medication will be determined by the study protocol and the patient's individual health needs.
Step 2
Monitoring and assessment
Throughout the treatment, the patient's response to the medications will be closely monitored. This includes regular assessments to evaluate the effectiveness and safety of the treatment.
The primary focus is on the objective response rate, which measures how well the cancer responds to the treatment. This will be assessed using imaging techniques like CT scans, following specific criteria known as RECIST v1.1.
Safety assessments will also be conducted to monitor any adverse effects that may occur as a result of the treatment.
Step 3
Follow-up phase
After completing the initial treatment phase, the patient will enter a follow-up phase. This involves continued monitoring to track the progression-free survival and overall survival.
Progression-free survival refers to the length of time during and after the treatment that the patient lives with the disease without it getting worse.
Overall survival is the duration from the start of the study until death from any cause. These metrics help determine the long-term effectiveness of the treatment.
Step 4
End of study
The study is expected to conclude by July 2030. At this point, all data collected will be analyzed to evaluate the overall success of the treatment regimen.
The results will contribute to understanding the potential benefits and risks of reducing chemotherapy cycles in combination with pembrolizumab for treating PD-L1-positive recurrent or metastatic head and neck squamous cell carcinomas.

Who can join the trial?

16 criteria

Must be at least 18 years old on the day of signing the consent form.
Must have test results for HPV status for certain throat cancers. HPV is a virus that can affect some cancers.
Women who can have children must have a negative pregnancy test before starting the study treatment.
Women who can have children must agree to use birth control, be surgically sterile, or not engage in heterosexual activity during the study and for a certain time after the last dose of treatment.
Men must agree to use birth control during the study and for 180 days after the last dose of treatment.
Must sign a written consent form agreeing to participate in the study.
Must be able to participate and willing to follow the study rules.
Must have health insurance in France.
Must have a specific type of head and neck cancer that has come back or spread and cannot be treated with the aim to cure.
Must not have received previous treatment for cancer that has come back or spread.
If previously treated with a certain type of chemotherapy for advanced cancer, it must have ended at least 6 months before joining the study.
The main cancer must be in specific areas like the throat, mouth, or voice box, but not in areas like the nose or skin.
Must have a certain score (CPS PD-L1 ≥ 1) from a test that measures a protein related to cancer. This can be from a new or old tissue sample.
Must have cancer that can be measured on a CT scan, a type of imaging test.
Must have a performance status of 0 or 1 on the ECOG scale, which measures daily living abilities.
Must have adequate organ function, meaning organs are working well enough, as defined by specific medical tests.

Who cannot join the trial?

20 criteria

Patients who have had previous treatment for their head and neck cancer.
Patients with other types of cancer that are not head and neck squamous cell carcinomas.
Patients who have serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are not able to follow the study procedures or attend study visits.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.
Patients with infections that are not well controlled.
Patients with a history of certain heart problems.
Patients with a history of certain lung problems.
Patients with a history of certain liver problems.
Patients with a history of certain kidney problems.
Patients with a history of certain immune system problems.
Patients who have received a live vaccine within 30 days before the start of the study.
Patients who have had a major surgery within 4 weeks before the start of the study.
Patients who have a history of drug or alcohol abuse.
Patients who have a history of mental health conditions that are not well controlled.
Patients who have a history of certain blood disorders.
Patients who have a history of certain neurological disorders.
Patients who have a history of certain gastrointestinal disorders.

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Verified sites

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

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
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Centre Hospitalier Et Universitaire De Limoges
Limoges, France

Trial locations

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. This medication is used in combination with chemotherapy to treat patients with certain types of head and neck cancer that have returned or spread to other parts of the body.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, a shortened regimen of chemotherapy is being tested to see if it is effective and safe when used with pembrolizumab for treating head and neck cancer. The goal is to reduce the number of chemotherapy cycles while still effectively treating the cancer.

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 for various cancers, including head and neck squamous cell carcinomas. The main therapeutic indication for pembrolizumab in this context is the first-line treatment of PD-L1-positive recurrent or metastatic head and neck squamous cell carcinomas. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody and is part of the broader category of immune checkpoint inhibitors.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It is characterized by the abnormal growth of these cells, which can form tumors. The disease can be recurrent, meaning it returns after treatment, or metastatic, indicating it has spread to other parts of the body. The progression of this cancer can vary, with some tumors growing slowly while others may spread more rapidly. Factors such as the presence of the PD-L1 protein can influence the behavior and treatment response of the cancer.