Not recruiting

Study of Lenvatinib and Pembrolizumab for Patients with Recurrent or Metastatic Head and Neck Cancer After Platinum and Immunotherapy Treatment

Verified siteRegistered drugNo placebo

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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 treatments for recurrent or metastatic squamous cell carcinoma of the head and neck, a type of cancer that has returned or spread to other parts of the body. The study will explore the effectiveness and safety of different treatment options. One of the treatments being tested is a combination of two medications: lenvatinib (also known by the code name MK-7902) and pembrolizumab (also known by the code name MK-3475). These medications will be compared to standard chemotherapy treatments, which include drugs like docetaxel, cetuximab, capecitabine, and paclitaxel.

The purpose of the study is to determine how well these treatments work in patients whose cancer has progressed after previous treatments, including platinum-based chemotherapy and immunotherapy targeting PD-1/PD-L1 proteins. Participants in the study will be randomly assigned to receive either the combination of lenvatinib and pembrolizumab, lenvatinib alone, or one of the standard chemotherapy options. The study will monitor the response of the cancer to these treatments over time.

Throughout the study, participants will receive their assigned treatment and will be regularly monitored by healthcare professionals. The study aims to gather information on how the cancer responds to the treatments, how long the response lasts, and any side effects experienced by participants. This information will help researchers understand which treatment options may be most effective for patients with this type of cancer.

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
Randomization
Upon joining the study, participants are randomly assigned to one of three treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.
Step 2
Treatment group 1: lenvatinib and pembrolizumab
Participants in this group receive a combination of lenvatinib and pembrolizumab.
Lenvatinib is taken orally in the form of capsules. The dosage and frequency are determined by the study team based on individual needs.
Pembrolizumab is administered through an intravenous infusion. The frequency and duration of the infusion are specified by the study protocol.
Step 3
Treatment group 2: standard chemotherapy
Participants in this group receive standard chemotherapy, which may include medications such as docetaxel, cetuximab, capecitabine, and paclitaxel.
These medications are administered either orally or through intravenous infusion, depending on the specific drug and treatment plan.
Step 4
Treatment group 3: lenvatinib monotherapy
Participants in this group receive lenvatinib alone.
Lenvatinib is taken orally in the form of capsules. The dosage and frequency are determined by the study team based on individual needs.
Step 5
Monitoring and assessments
Throughout the study, participants undergo regular monitoring and assessments to evaluate the effectiveness and safety of the treatment.
These assessments may include imaging tests, blood tests, and other evaluations as required by the study protocol.
Step 6
Completion of treatment
Upon completion of the treatment period, participants may undergo final assessments to determine the overall response to the treatment.
The study team will provide guidance on any follow-up care or additional treatments that may be necessary.

Who can join the trial?

12 criteria

The patient must have a type of cancer called recurrent or metastatic squamous cell carcinoma of the head and neck, which cannot be cured with local treatments.
If the patient has hepatitis B, they must have been treated with antiviral medication for at least 4 weeks and have no detectable virus in their blood before starting the study.
If the patient has a history of hepatitis C, the virus must not be detectable in their blood at the start of the study.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
The patient's disease must have gotten worse during or after treatment with a platinum-containing regimen, which is a type of chemotherapy.
The patient's disease must have gotten worse after treatment with an anti-PD-1/PD-L1 monoclonal antibody, which is a type of cancer treatment that helps the immune system fight cancer.
The patient must have imaging tests that show their disease has gotten worse, based on a review of at least two images taken before the study.
The patient must have measurable disease, meaning the cancer can be measured using a CT or MRI scan, even if it is in an area that was previously treated with radiation.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Male patients must agree to avoid donating sperm and use contraception or remain abstinent from heterosexual intercourse during the study and for a specified time after the last dose of the study drugs.
Female patients must not be pregnant or breastfeeding and must use effective contraception or remain abstinent from heterosexual intercourse during the study and for a specified time after the last dose of the study drugs.
The patient must have adequately controlled blood pressure, whether or not they are taking medication for it.

Who cannot join the trial?

13 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have a medical condition that could interfere with the study treatment.
Patients who are currently pregnant or breastfeeding.
Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread).
Patients who have an active infection that requires treatment.
Patients who have a known allergy to the study drugs.
Patients who have received certain treatments for cancer within a specific time before the study.
Patients who have a history of certain heart conditions.
Patients who have uncontrolled high blood pressure.
Patients who have a history of bleeding disorders.
Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have a history of organ transplant.
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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Centre Henri Becquerel
Verified
Rouen, France
Centre Jean Perrin
Verified
Clermont Ferrand, France

Trial locations

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Investigated drugs

Lenvatinib
is a medication used in this trial to treat participants with head and neck cancer that has returned or spread after previous treatments. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.
Pembrolizumab
is another medication used in this trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used in combination with lenvatinib to enhance the treatment's effectiveness against head and neck cancer.
Standard of Care Chemotherapy
refers to the usual chemotherapy treatments that are commonly used for head and neck cancer. These treatments aim to kill or stop the growth of cancer cells and are used as a comparison to evaluate the effectiveness of the new combination therapy in the trial.

What is already known about the treatment

Lenvatinib
Lenvatinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating recurrent or metastatic squamous cell carcinoma of the head and neck. The medication works by inhibiting certain proteins that promote the growth of cancer cells, specifically targeting the vascular endothelial growth factor receptors. It is classified as a tyrosine kinase inhibitor, which helps to slow down or stop the growth of cancer cells.
Pembrolizumab
Pembrolizumab is given as an intravenous infusion. It is under investigation in clinical trials for its potential to treat recurrent or metastatic squamous cell carcinoma of the head and neck. This medication functions by blocking a specific protein on immune cells, known as PD-1, which helps the immune system to better recognize and attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, enhancing the body's immune response against cancer.

Investigated diseases

Recurrent or metastatic squamous cell carcinoma of the head and neck – This is a type of cancer that originates in 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. When the cancer is recurrent, it means it has returned after treatment. If it is metastatic, it has spread to other parts of the body beyond the head and neck region. The disease can progress by invading nearby tissues and spreading to lymph nodes or distant organs. Symptoms may include persistent sore throat, difficulty swallowing, and changes in voice.