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Study of ALX148 and Pembrolizumab for Patients with Advanced 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 called advanced head and neck squamous cell carcinoma. This cancer can be challenging to treat, especially when it has spread to other parts of the body or cannot be removed by surgery. The study is testing a combination of two treatments: ALX148 and pembrolizumab. ALX148 is a new type of treatment that is given as an injection, while pembrolizumab, also known as Keytruda, is a well-known medication used to help the immune system fight cancer. Both treatments are administered through a vein, a method known as intravenous administration.

The purpose of this study is to see how well the combination of ALX148 and pembrolizumab works in improving the survival rate and response to treatment in patients with this type of cancer. Participants in the study will receive these treatments over a period of up to 24 months. The study will monitor how the cancer responds to the treatment and how long the effects last. It will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, participants will have regular visits to the clinic for treatment and check-ups. These visits will include various tests to monitor the cancer and overall health. The study aims to provide valuable information on the effectiveness of combining ALX148 with pembrolizumab for treating advanced head and neck squamous cell carcinoma.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A biopsy sample is required to confirm specific biomarkers. This sample should ideally be taken after the most recent therapy for head and neck squamous cell carcinoma (HNSCC).
Step 2
Screening tests
Screening tests are performed to ensure all health criteria are met. These tests include blood tests to check bone marrow, liver, and kidney function.
A pregnancy test is conducted for females of childbearing potential.
Step 3
Treatment initiation
Treatment begins with the administration of two medications: ALX148 and pembrolizumab. Both are given through intravenous administration.
The medication pembrolizumab is provided as a concentrate for solution for infusion, known as KEYTRUDA 25 mg/mL.
Step 4
Treatment schedule
The treatment is administered on a regular schedule. The specific frequency and duration of each medication will be explained by the healthcare provider.
Regular monitoring is conducted to assess the response to treatment and to manage any side effects.
Step 5
Follow-up assessments
Follow-up assessments are scheduled to evaluate the effectiveness of the treatment. These include imaging tests to measure tumor response.
Blood tests and other evaluations are performed to monitor overall health and detect any adverse effects.
Step 6
End of study
The study is expected to conclude by December 31, 2024. At the end of the study, a final assessment is conducted to evaluate the overall outcomes.
Participants may be asked to continue follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

16 criteria

Patients must have a type of cancer called **head and neck squamous cell carcinoma (HNSCC)** that has spread or cannot be removed by surgery, and it must be **PD-L1 positive**. This means the cancer has a specific protein that can be detected by a test.
Patients should not have received any previous treatment for their advanced cancer. However, if they had treatment for an earlier stage of the disease, it must have been completed more than 6 months ago.
Patients must have recovered from any side effects of previous treatments to a mild level, except for side effects that are not considered risky, like hair loss. Patients with mild nerve damage may still be eligible.
A sample from a previous biopsy, preferably taken after the most recent treatment, must be available for testing.
Women who can have children must have a negative pregnancy test before starting the study.
Both men and women who can have children must agree to use effective birth control during the study and for at least 120 days after the last treatment.
Patients must provide a signed consent form indicating they understand the study details.
Patients must be willing and able to attend scheduled visits and follow the treatment plan.
Patients must have at least one measurable tumor that can be tracked during the study.
Patients must have adequate **bone marrow function**, which means having enough healthy blood cells.
Patients must have adequate **kidney function**, which means their kidneys are working well enough.
Patients must have adequate **liver function**, which means their liver is working well enough.
Patients must be at least 18 years old, unless the local regulations require a higher minimum age.
Patients must have normal blood clotting levels unless they are on blood-thinning medication.
Patients must have a good general health status, as measured by a specific scale called the **ECOG Performance Status**.
Patients with a specific type of throat cancer must have results from a test for a virus called **HPV**.

Who cannot join the trial?

6 criteria

Patients who have already received treatment for their advanced disease cannot participate.
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Patients with a condition that is not **metastatic** or **unresectable, recurrent HNSCC** are excluded.
- Metastatic means the cancer has spread to other parts of the body.
- Unresectable means the cancer cannot be removed with surgery.
- Recurrent means the cancer has come back after treatment.
- HNSCC stands for head and neck squamous cell carcinoma, a type of cancer in the head and neck area.
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  Patients with a **CPS** less than 1 are not eligible.
  - CPS stands for Combined Positive Score, a measure used to evaluate certain proteins in cancer cells.

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Verified sites

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

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

ALX148
is an investigational medication being studied for its potential to help the immune system fight cancer. It is used in combination with other treatments to see if it can improve outcomes for patients with certain types of cancer, such as advanced head and neck squamous cell carcinoma.
Pembrolizumab
is a medication that helps the immune system detect and fight cancer cells. It is used in various types of cancer treatments and is being studied in combination with other drugs to see if it can improve survival rates and response rates in patients with advanced head and neck squamous cell carcinoma.

Pembrolizumab

What is already known about the treatment

ALX148
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced head and neck squamous cell carcinoma (HNSCC). It is not yet widely recognized in medical literature as a standard treatment. ALX148 is designed to enhance the immune system's ability to fight cancer by blocking a protein that helps cancer cells evade immune detection. It is classified as an immune checkpoint inhibitor.
Pembrolizumab
This medication is given through an intravenous infusion and is an established treatment in the medical field, particularly for various types of cancer, including advanced head and neck squamous cell carcinoma (HNSCC). It works by targeting and inhibiting a specific protein on immune cells, allowing the immune system to better identify and attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and an immune checkpoint inhibitor.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) – 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 can become metastatic, meaning it spreads to other parts of the body, or unresectable, indicating it cannot be surgically removed. Recurrent HNSCC refers to cancer that has returned after treatment. The disease often progresses through stages, starting from localized growths to more advanced stages where it spreads to lymph nodes or distant organs. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. The progression can vary, with some cases remaining localized while others spread more aggressively.